DSM-IV Criteria For Opioid Dependence Research Articles

Validation of Two Diagnostic Assessments for Opioid and Stimulant Use Disorder for Use by Non-Clinicians.

The United States is in the fourth wave of the opioid epidemic marked by the increase in fentanyl and co-occurring stimulant use related overdose deaths. Measures are needed to quickly diagnose opioid and stimulant use disorders, yet current traditional diagnostic assessments pose barriers to providing rapid diagnoses. This study aimed to (1) validate an updated version of the Rapid Opioid Dependence Screen (RODS) from DSM-IV criteria for opioid dependence to the now DSM-5 moderate-to-severe opioid use disorder, the Rapid Opioid Use Disorder Assessment (ROUDA); and (2) create and validate the Rapid Stimulant Use Disorder Assessment to DSM-5 stimulant use disorder (RSUDA) when compared to the substance use disorder module from the DSM-5 version of the Mini International Neuropsychiatric Interview. One-hundred and fifty adults completed study assessments, 122 reported opioid misuse and 140 reported stimulant misuse within their lifetime. The ROUDA had a sensitivity of 82.5% (95% confidence interval [CI]75.7, 89.2), specificity of 100.0% (95% CI: 100, 100), and strong internal consistency α=0.94. The RSUDA had similarly high sensitivity (83.8%, 95% CI: 77.7, 89.9), specificity (91.4%, 95% CI: 86.8, 96.1), and internal consistency α=0.87. The ROUDA and RSUDA are efficient and valid measures that can be administered in various settings by non-clinical staff to rapidly diagnose opioid and stimulant use disorders and allow for immediate treatment and harm reduction interventions. The ROUDA and RSUDA are efficient and valid measures that can be administered by non-clinicians to rapidly diagnose opioid and stimulant use disorders.

Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial

BackgroundAs the USA grapples with an opioid epidemic, medical emergency departments (EDs) have become a critical setting for intervening with opioid-dependent patients. Brief interventions designed to bridge the gap from acute ED care to longer-term treatment have shown limited efficacy for this population. Strength-based case management (SBCM) has shown strong effects on treatment linkage among patients with substance use disorders in other healthcare settings. This study aimed to investigate whether SBCM is an effective model for linking opioid-dependent ED patients with addiction treatment and pharmacotherapy. Here, we describe the implementation and challenges of adapting SBCM for the ED (SBCM-ED). Study rationale, design, and baseline characteristics are also described.MethodsThis study compared the effects of SBCM-ED to screening, assessment, and referral alone (SAR) on treatment linkage, substance use, and functioning. We recruited participants from a public hospital in NYC. Working alliance between case managers and participants and the feasibility of SBCM implementation were evaluated. Baseline data from the randomized sample were analyzed for group equivalency. Outcomes analyses are forthcoming.ResultsThree hundred adult participants meeting DSM-IV criteria for opioid dependence were randomly assigned to either SBCM, in which they received a maximum of six case management sessions within 90 days of enrollment, or SAR, in which they received a comprehensive referral list and pamphlet outlining drug use consequences. No significant differences were found between groups at baseline on demographic or substance use characteristics. All SAR participants and 92.6% of SBCM-ED participants initiated their assigned intervention. Over half of SBCM-ED first sessions occurred in the ED on the day of enrollment. Case managers developed a strong working alliance with SBCM-ED participants after just one session.ConclusionInterventions that exceed SBIRT were accepted by an opioid-dependent patient population seen in an urban medical ED. At the time of study funding, this trial was one of the first to focus specifically on this population in this challenging setting. The successful implementation of SBCM demonstrates its adaptability to the ED and may serve as a potential model for EDs seeking to adopt an intervention that overcomes the barrier between the ED encounter and more intensive treatment.Trial registrationClinicalTrials.gov NCT02586896. Registered on 27 October 2015.

Gender differences in prescription opioid use and misuse: Implications for men's health and the opioid epidemic

The majority of research on gender and the opioid epidemic focuses on women as patients, caregivers, or expectant mothers. However, little research approaches men as gendered subjects, despite their dramatically increased risk of opioid overdose. Accordingly, we examined gender differences in prescription opioid use and misuse with specific attention to implications for men using data from the 2017 National Survey on Drug Use and Health. We used design-adjusted, weighted Wald tests and multivariate logistic regression to compare gender differences in rates of prescription opioid use and misuse, prescription opioid sources, primary motivation for misuse, and prescription opioid dependence. We found that although men were significantly less likely than women to report opioid use, they were significantly more likely to report opioid misuse and to misuse prescription opioids primarily to feel good or get high. Among past-year opioid users, men were significantly more likely than women to meet DSM-IV criteria for opioid dependence. Results are consistent with past work on the intersection of masculinity norms and health behaviors. Although gender-specific interventions are typically synonymous with interventions tailored to women, our results suggest that such interventions could alleviate the burden of the opioid epidemic for men as well. Further research studying possible mechanisms that explain men's increased vulnerability to the opioid epidemic is urgently needed to address this growing public health crisis.

Re-engineering methadone—Cost-effectiveness analysis of a patient-centered approach to methadone treatment

Methadone maintenance treatment has proven effectiveness in the treatment of opioid use disorder, but significant barriers remain to treatment retention. In a randomized clinical trial, 300 newly-admitted methadone patients were randomly assigned to patient-centered methadone (PCM) v. treatment-as-usual (TAU). In PCM, participants were treated under revised program rules which permitted voluntary attendance at counseling and other changes focused on reducing involuntary discharge, and different staff roles which shifted disciplinary responsibility from the participant's counselor to the supervisor. The study found no significant differences in treatment retention, measures of opioid use, or other patient outcomes. This paper employs an activity-based costing approach to estimate the cost and cost-effectiveness of the two study conditions. We found that service use and costs were similar between PCM and TAU. Specifically, the average cost for PCM patients was $2396 compared to $2292 for standard methadone, while the average length of stay was 2 weeks longer for PCM patients. Incremental cost-effectiveness ratios (ICER) for self-reported heroin use, opioid positive urine screens, and meeting DSM-IV criteria for opioid dependence were mixed, with TAU achieving non-significantly better outcomes at lower treatment episode costs (i.e., economically dominating) for opioid positive urine screens. PCM patients reported slightly more days abstinent from heroin and fewer meet the opioid dependence criteria. While these differences are small and not statistically significant, we can still examine the cost-effectiveness implications. For days, abstinent from heroin, the ICER was $242 for one additional day of abstinence, however, there was notable uncertainty around this estimate. For opioid dependence criteria, the ICER was $1160 for a one-percentage point increase in the probability that a participant no longer met criteria for opioid dependence at follow-up. This economic study finds that patient choice concepts can be introduced into methadone treatment without significant impacts on costs or patient outcomes.

Predictors of buprenorphine treatment success of opioid dependence in two Baltimore City grassroots recovery programs

IntroductionDespite evidence for the efficacy of buprenorphine treatment in primary care, few studies have identified factors associated with treatment success, nor have such factors been evaluated in community settings. Identifying correlates of treatment success can facilitate the development of treatment models tailored for distinct populations, including low-income communities of color. The current study examined client-level socio-demographic factors associated with treatment success in community-based buprenorphine programs serving vulnerable populations. MethodsData were abstracted from client records for participants (N=445) who met DSM-IV criteria for opioid dependence and sought treatment at one of Behavioral Health Leadership Institute's two community-based recovery programs in Baltimore City from 2010 to 2015. Logistic regression estimated the odds ratios of treatment success (defined as retention in treatment for ≥90days) by sociodemographic predictors including age, race, gender, housing, legal issues and incarceration. ResultsThe odds of being retained in treatment ≥90days increased with age (5% increase with each year of age; p<0.001), adjusting for other sociodemographic factors. Clients who reported unstable housing had a 41% decreased odds of remaining in treatment for 90 or more days compared to clients who lived independently at intake. Treatment success did not significantly differ by several other client-level characteristics including gender, race, employment, legal issues and incarceration. ConclusionsIn vulnerable populations, the age factor appears sufficiently significant to justify creating models formulated for younger populations. The data also support attention to housing needs for people in treatment. Findings from this paper can inform future research and program development.

Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study

BackgroundDespite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). MethodsPOATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. ResultsAt Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29–16.04, p<.05). Engagement in agonist therapy was associated with a greater likelihood of illicit-opioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. ConclusionsLong-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use.

A needs comparison of justice-involved Iraq/Afghanistan veterans to other service eras

s / Drug and Alcohol Dependence 146 (2015) e34–e117 e55 evaluated by randomly assigning parolees to 6monthly naltrexone injections or treatment as usual (TAU) without medication. Methods: All patients met DSM-IV criteria for opioid dependence. 308 parolees were randomized and 290 are now eligible for 6-month follow up. The naltrexone group received 6 monthly injections of 380mg and amonthly visit with a nurse. The parolees randomized to TAU received help in joining a community counseling program. Outcomes were measured by urine tests and self-report. Results: Retention rates in treatment at 27, 52, and 78 weeks were 64%, 58% and 54% for the TAU group and 66%, 54% and 52% for the naltrexone group. Urine tests were examined at 27, 52 and 78 weeks andwithpooleddata fromall 5 sites, therewere significantly fewer opioid positive urines in the naltrexone group (p< .0001 for the pooled analysis). The rate of positive opioids for TAU was 3.36 times higher than that for naltrexone. No significant differencewas found for other drugs. There were 2 opioid overdoses in the TAU group and none in the naltrexone group. There were 4 deaths from all causes in the TAU group and 2 deaths in the naltrexone group unrelated to medication. Conclusions: A monthly injection of depot naltrexone significantly reduced opioid relapse in parolees. Six-month retentionwas similar in the two groups. Serious adverse events including opioid overdose occurred less often in the group receiving naltrexone (18 naltrexone vs. 43 for TAU). In this interim analysis, depot naltrexone was found to be both safe and effective in reducing the rate of relapse to opioid use. Financial support: This research was supported by collaborative RO-1 grants to the 5 sites involved. The extended release naltrexone in the form of Vivitrol was supplied by Alkermes Inc. http://dx.doi.org/10.1016/j.drugalcdep.2014.09.519 A needs comparison of justice-involved Iraq/Afghanistan veterans to other service eras Kathryn O’Connor1,2, Debra A. Pinals3,1, David Smelson1,2, Leon Sawh2,4,1, Carl Fulwiler1, Stephanie Singer1, William Fisher4, Stephanie Hartwell5, Gerardo Gonzalez1 1 University of Massachusetts Medical School, Worcester, MA, United States 2 US Department of Veterans Affairs, Bedford, MA, United States 3 Massachusetts Department of Mental Health, Boston, MA, United States 4 University of Massachusetts, Lowell, Lowell, MA, United States 5 University of Massachusetts, Boston, Boston, MA,

Risk-Taking Propensity as a Predictor of Induction Onto Naltrexone Treatment for Opioid Dependence

Heroin addiction is a chronic relapsing disorder that has devastating social, medical, and economic consequences. Naltrexone is an antagonist that blocks opioid effects and could be an effective medication for the treatment of opioid dependence. However, its clinical utility has been limited partly because of poor adherence and acceptability. Given the importance of compliance to naltrexone treatment for opioid dependence, the goal of the current study was to examine predictors involved in successful induction onto naltrexone treatment. Parametric and nonparametric statistical tests were performed on data from a sample of 64 individuals entering treatment who met DSM-IV criteria for opioid dependence. The relationship between naltrexone induction (ie, inducted vs not inducted onto naltrexone) and risk-taking propensity, as indexed by riskiness on the Balloon Analogue Risk Task (BART), was examined. Participants were recruited from local detoxification programs, inpatient drug treatment, and other Baltimore programs that provided services to opioid-dependent adults (eg, Baltimore Needle Exchange Program) during the period from August 2007 to September 2008. Positive association was shown between risk-taking propensity and odds of naltrexone induction. Specifically, each 5-point increase in the total BART score was associated with a 25% decrease in odds of naltrexone induction (OR = 0.76; 95% CI, 0.58-0.99; P = .041). This association remained statistically significant, even after adjusting for potential confounds, including injection drug use and cocaine positive urine results (P = .05). After adjusting for the covariates, each 5-point increase in BART score was associated with 28% decrease in the odds of achieving the maintenance dose (adjusted OR = 0.73; 95% CI, 0.54-0.99; P = .046). Risk-taking propensity was predictive of induction onto naltrexone treatment, above and beyond injection drug use and cocaine-positive urine samples.

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community — A potential conduit to improved HIV treatment outcomes

BackgroundHIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners. MethodsSentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6months after the intervention period. Assessments occurred within 90days pre-release (baseline), day of release, and then monthly for 12months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12months. The primary outcome was pre-defined as viral suppression (VL<400copies/mL) at 6months. ResultsBetween 2004 and 2009, 279 participants were screened, of which 202 met eligibility criteria and 154 were ultimately enrolled in the study; 103 subjects were randomized to DAART and 51 to SAT. Subjects were mostly male (81.2%), people of color (87.0%), had an alcohol use disorder (39.7%), had underlying depression (54.2%), were virally suppressed (78.8%) and had a mean CD4=390.7cells/mL. ConclusionsOutcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.

Commentary on Boscarino et al. (2010): Understanding the spectrum of opioid abuse, misuse and harms among chronic opioid therapy patients

In this issue, Boscarino et al. [1] report that one in four chronic opioid therapy (COT) patients in general practice met DSM-IV criteria for current opioid dependence. Since over five million Americans use COT on a regular basis while several million more chronic pain patients use opioids intermittently [2], understanding the extent of opioid abuse, misuse and opioid-related harms among COT patients is of clinical and public health significance. How does the high estimate of the prevalence of opioid dependence reported by Boscarino et al. compare to other estimates? A Cochrane review reported that only 0.27% of COT patients enrolled in randomized trials abused opioids [3]. Fishbain et al.’s [4] meta-analysis found that 3.3% of COT patients abused opioids, 11.5% had aberrant drug use behaviors, and 14.5% had illicit substances detected by urine drug screening. However, COT patients pre-screened for substance abuse risk had very low rates of opioid abuse and aberrant drug use behaviors. Given these disparate results, it is not surprising that confusion reigns about the extent of opioid abuse, misuse and opioid-related harms among COT patients. Among COT patients enrolled in randomized trials, low rates of opioid abuse are likely due to careful pre-screening of patients and, in some trials, use of passive methods with poor sensitivity for detecting opioid abuse. Since screening of COT patients for abuse risk is often cursory in general practice, the low rates of opioid abuse among pre-screened COT patients reported in structured reviews [3,4] are likely not generalizable to typical COT patients in primary care. However, DSM-IV criteria for opioid dependence have limitations in assessing opioid abuse among COT patients. Physiological dependence, tolerance, and withdrawal do not necessarily implicate a maladaptive pattern of substance use among chronic pain patients receiving medically prescribed opioids. Proposed DSM-V criteria do not consider either opioid tolerance or withdrawal among persons receiving medically prescribed analgesics in diagnosing opioid use disorder. For this reason, Boscarino et al.’s [1] prevalence estimate based on DSM-IV criteria is higher than would be found if opioid tolerance and withdrawal were ignored. In the absence of studies directly evaluating DSM-V criteria for opioid use disorder among COT patients, Fishbain et al.’s meta-analysis results [3] are useful, likely conservative, estimates of the extent of opioid abuse, aberrant drug use, and concurrent use of illicit substances among COT patients. Boscarino et al.’s finding [1] that opioid dependence was predicted by substance abuse history and psychological disorder are consistent with Fishbain et al.’s observation [3] that pre-screening yields low rates of opioid abuse and misuse among COT patients. These findings call attention to the importance of careful evaluation of opioid abuse risk among patients being considered for COT. Before adopting a sanguine view that opioid-related problems are relatively uncommon among COT patients, and that risks could be further reduced by pre-screening, there are troubling observations that need to be considered. COT patients without an opioid use disorder often have opioid-related problems. Fleming et al. [5] found that among COT patients without any substance use disorder, 19% purposely over-sedated themselves, 12% used opioids for reasons other than pain control, 16% used alcohol to relieve pain, 29% felt intoxicated when using opioids, and 33% increased opioid dose on their own. Banta-Green et al. [6] found that among typical COT patients without a pattern of addictive behaviors, 49% wanted to stop or cut-down use of opioids, 14% were angry or mistrustful of doctors, 9% borrowed opioid medicines, and 34% needed more opioids to achieve the same effect. COT patients in general practice often have: high levels of pain-related interference with major social role activities; apathy, lethargy, avoidance and depression; and other psychosocial problems and concerns potentially related to opioid use [7]. There are also risks of opioid-related medical harms among COT patients with potentially serious consequences including: opioid overdose [8], serious fractures [9], pneumonia [10], sleep-disordered breathing [11], opioid-induced hyperalgesia [12], chronic constipation [13], and hypogonadism [14], among others [15]. Given a wide-spectrum of opioid-related problems, along with conceptual and methodological difficulties in defining opioid use disorder among COT patients, focusing on opioid abuse as the predominate risk associated with COT seems too narrow. Rather, careful studies of the full spectrum of opioid-related problems among COT patients are needed, including opioid abuse, misuse, psychosocial harms and medical harms. Since specific manifestations of opioid abuse, misuse, psychosocial harms and medical harms are often not highly correlated, it is important to know the frequency of each kind of opioid-related problem, along with the distribution of number of problems observed among COT patients (e.g. 0, 1, 2 or more). Summary classifications, like DSM-IV opioid dependence or DSM-V opioid use disorder, do not adequately convey the character, range and extent of opioid-related problems among COT patients in general practice settings.

Mortality in Opioid-Maintained Patients after Release from an Addiction Clinic

Aim: To investigate the mortality rate in a cohort of 269 opioid-dependent patients and the outcome of survivors meeting DSM-IV criteria for opioid dependence. Design: Retrospective cohort study. Participants: Patients enrolled in synthetic opioid maintenance therapy during a time frame from 1998 to 1999 originally at the Addiction Clinic and then discharged to general practitioners. Methods: Structured interviews (Europ-ASI), urinalysis at time of interview as well as autopsy findings from deceased patients. Results: After six mailings, information from 147 (54.6%) patients was gained. 85 patients (31.6%) were interviewed. From these 76.5% (n = 65) were still enrolled in maintenance therapy, 18.8% (n = 16) were drug-free and 4.7% (n = 4) relapsed. From 29 fatalities, 37.9% died of intoxication with illicit substances, 34.5% related to AIDS and 27.6% of somatic complications. The Standardized Mortality Ratio (SMR) was 29.13 (95% CI = 19.27–44.04). A higher lifetime frequency of hospitalization, less working days and a lack of social relationships were factors associated with high mortality. Conclusions: The study confirms the high mortality rate in this patient group and supports the importance of maintenance therapy. Although great efforts were undertaken in locating patients, about 45% of the target group could not be located.

Management of relapse in naltrexone maintenance for heroin dependence

Opioid dependence is a growing public health problem. Maintenance on the antagonist naltrexone for clinic- or office-based treatment of opioid dependence is plagued by high rates of relapse. This paper identifies critical determinants of lapses to opioid use during naltrexone maintenance. Time retained in treatment was examined as a function of whether lapses to opioid use occurred while adherent to naltrexone (blocked use), or after having missed naltrexone doses (unblocked). Method Participants ( N = 83) met DSM-IV criteria for opioid dependence and identified a significant other willing to participate in their treatment. Following inpatient detoxification, participants were enrolled in a 26-week outpatient course of therapy and naltrexone maintenance. Results Patients with unblocked use had a very high rate of dropout (10% retained at 6 months), dropout usually occurring within 2 weeks after unblocked use. Patients with only blocked use had less dropout (33% retained at 6 months). However, episodes of blocked use were often followed by unblocked use and dropout. Conclusions During naltrexone maintenance for opioid dependence unblocked opioid use calls for immediate intervention, such as detoxification or switching to the partial agonist buprenorphine. Episodes of blocked use warrant increased clinical attention, such as direct observation of naltrexone ingestion, increased dose, or increased intensity of treatment contact. Maintenance on oral naltrexone is a fragile treatment because it is so easily undermined by episodes of opioid use while non-compliant. New long-acting injectable or implantable formulations of naltrexone may address this limitation and should be investigated for treatment of opioid dependence.

Multimodal drug addiction treatment: A field comparison of methadone and buprenorphine among heroin- and cocaine-dependent patients

Aims Our objective was to compare the effectiveness of buprenorphine (BUP) and methadone maintenance treatment in opiate-addicted patients in a clinical nonexperimental setting. Design We used a naturalistic observational prospective study of 24 months' duration. Setting Subjects were enrolled and treated at a drug addiction outpatient clinic of the National Health System Local Unit in Milan, Italy. Participants Two hundred fifty-seven subjects meeting the DSM-IV criteria for opioid dependence and opioid-seeking substitutive pharmacological treatment participated in the study. Intervention One hundred twenty-one subjects received BUP at a mean daily dose of 11 ± 6 mg (median = 8; range = 2–30) for a mean duration of 249 days. One hundred thirty-six subjects received methadone at a mean daily dose of 54 ± 29 mg (median = 50; range = 4–140) for a mean duration of 267 days. Measurements The main efficacy parameters were treatment retention rates and illicit substance abuse, as assessed by urinalysis. Findings Retention rates were comparable in both treatment groups, but BUP-treated subjects had significantly lower rates of illicit opiate consumption ( p < .0001). Conclusions The results confirm that, in a nonexperimental clinical practice setting, BUP is as effective as methadone in the treatment of heroin dependence, with significantly better opiate abuse control, thus possibly allowing longer and more effective treatment programs with reduced relapse rates.

Comparison of Pharmacological Treatments for Opioid-Dependent Adolescents

The prevalence of heroin and other opioid use has markedly increased among adolescents in the last decade; however, virtually no research has been conducted to identify effective treatments for this population. To evaluate the relative efficacy of 2 pharmacotherapies, the partial opioid agonist buprenorphine hydrochloride and the centrally active alpha(2)-adrenergic blocker clonidine hydrochloride, in the detoxification of opioid-dependent adolescents. A double-blind, double-dummy, parallel-groups randomized controlled trial conducted in a university-based research clinic from October 2001 to December 2003. Patients were a volunteer sample of 36 adolescents who met DSM-IV criteria for opioid dependence (ages 13-18 years eligible). Participants were randomly assigned to a 28-day, outpatient, medication-assisted withdrawal treatment with either buprenorphine or clonidine. Both medications were provided along with thrice weekly behavioral counseling and incentives contingent on opiate abstinence. Postdetoxification, all participants were offered the opportunity for continued treatment with the opiate antagonist, naltrexone hydrochloride. Treatment retention, opiate abstinence, and human immunodeficiency virus risk behavior, along with measures of withdrawal and medication effects. A significantly greater percentage of adolescents who received buprenorphine were retained in treatment (72%) relative to those who received clonidine (39%) (P<.05). For those in the buprenorphine group, a significantly higher percentage of scheduled urine test results were opiate negative (64% vs 32%; P = .01). Participants in both groups reported relief of withdrawal symptoms and drug-related human immunodeficiency virus risk behavior. Those in the buprenorphine condition generally reported more positive effects of the medication. No evidence of opioid intoxication or psychomotor impairment was observed. Sixty-one percent of participants in the buprenorphine condition and 5% of those in the clonidine group initiated treatment with naltrexone. Combining buprenorphine with behavioral interventions is significantly more efficacious in the treatment of opioid-dependent adolescents relative to combining clonidine and behavioral interventions.

A double-blind, double-dummy, randomized, prospective pilot study of the partial Mu opiate agonist, buprenorphine, for acute detoxification from heroin

The optimum dose of buprenorphine for acute inpatient heroin detoxification has not been determined. This randomized, double-blind, double-dummy, pilot study compares two buprenorphine sublingual tablet dosing schedules to oral clonidine. Heroin users ( N = 30) who met DSM-IV criteria for opioid dependence and achieved a Clinical Opiate Withdrawal Scale (COWS) score of 13 (moderate withdrawal), were randomized to receive higher dose buprenorphine (HD, 8-8-8-4-2 mg/day on days 1–5), lower dose buprenorphine (LD, 2-4-8-4-2 mg/day on days 1–5), or clonidine (C, 0.2-0.3-0.3-0.2-0.1 mg QID on days 1–5). COWS scores were obtained QID. Twenty-four hours after randomization, the percentages of subjects who achieved suppression of withdrawal, as defined by four consecutive COWS scores <12, were: C = 11%, LD = 40%, and HD = 60%. Generalized estimating equation regression models, controlling for baseline COWS and time, indicated that COWS scores over the course of 5 days were lower in both LD and HD compared to C ( χ 2(2) = 13.28, P = 0.001). Similar analyses examining scores over time on the Adjective Rating Scale for Withdrawal (ARSW) and on a Visual Analog Scale of Opiate Craving (VAS) indicated an overall treatment effect on the VAS accounted for by a significant difference between HD and C, but no overall treatment effect on the ARSW. There were no discontinuations due to treatment-related adverse events. Both HD and LD regimens are safe and efficacious treatment for opioid detoxification, but HD demonstrated superiority to C on a greater number of measures.

Twelve-month maintenance treatment of opium-dependent patients

The goal of this study was to compare the effects of 1, 3 and 8 mg per day doses of buprenorphine in the maintenance treatment of opium-dependent subjects in Iran over a treatment period of 12 months. Participants were randomized to three equal groups (171 subjects per group) of opium-dependent individuals who met the DSM-IV criteria for opioid dependence and were seeking treatment. They were treated in an urban outpatient clinic, offering a 1-hour weekly individual counseling session. Overall, 282 subjects (55%) completed the 12 months study. Completion rates by dosage group were 46 (26.9%) for the 1 mg dose group, 102 (59.6%) for the 3 mg dose group, and 134 (78.4%) for the 8 mg dose group ( p = .000). These findings are consistent with previous reports of effective buprenorphine use in western countries as a suitable maintenance treatment for opium dependence.

Buprenorphine maintenance treatment of heroin dependence: the first experience from Iran

The aim of this study was to assess the efficacy of 1-, 2-, and 4-mg-per-day sublingual doses of buprenorphine in the maintenance treatment of heroin-dependent patients over a 17-week treatment period. Subjects were randomized to three dosage groups. Participants consisted of 105 heroin addicts (102 men and 3 women) who met the DSM-IV criteria for opioid dependence and were seeking treatment. Subjects received buprenorphine at a dose of 1, 2, or 4 mg per day and were treated in an urban outpatient clinic, including a weekly 1-hour individual counseling session. Days retained in treatment were measured. Overall, 49 patients (46.7%) completed the 17-week study. Completion rates by dosage group were 34.3% for the 1 mg dose group, 42.9% for the 2 mg dose group, and 62.9% for the 4 mg dose group. Retention in the 4 mg dose group was significantly better than in the 1 mg dose group ( P = .017). None of the other comparisons was significant. The results support the efficacy and safety of buprenorphine for outpatient treatment of heroin dependence and seem to indicate that the highest dose (4 mg) of buprenorphine was the best of the three doses for Iranian heroin addicts to increase their retention in treatment.

A controlled trial of buprenorphine treatment for opium dependence: the first experience from Iran

Aims: To evaluate the effect of a 4 mg/day sublingual dose of buprenorphine in the maintenance treatment of opium dependence in comparison with a 1 mg/day dose over an 18-week treatment period. As a secondary objective, the results were determined concurrently for subjects treated with a 2 mg/day dose. Design: Subjects were assigned randomly to three dosage groups. Participants: 330 consecutive (320 men and 10 women) opium addicts who met the DSM-IV criteria for opioid dependence and were seeking treatment. Intervention: Subjects received a 1, 2 or 4 mg/day dose of buprenorphine and were treated in an outpatient clinic where they also received a weekly 1-hour clinical counseling session. Measurements: Addiction Severity Index, retention in treatment, and illegal opioid use as determined by random urine testing. Findings: The mean age was 37.5 years (SD=11.4, range 19–72). Overall, 194 (58.8%) of the patients completed the 18 week study. Completion rates by dosage groups were 47.3% for the 1 mg group, 58.2% for the 2 mg group and 70.9% for the 4 mg group ( χ 2=12.7, df=2, P=0.0017). Conclusions: The results support the efficacy and safety of buprenorphine for opium addiction and suggest that an adequate dose of buprenorphine would help to increase the success rate.

Naltrexone for opioid dependence: evaluation of a manualized psychosocial protocol to enhance treatment response

AbstractThe clinical application of the narcotic antagonist, naltrexone for the treatment of opioid dependence has been minimal. This study evaluated the impact of a multi‐component, manualized, psychosocial protocol designed to enhance the clinical value of naltrexone for opioid dependence treatment. Eighty‐one detoxified individuals meeting DSM‐IV criteria for opioid dependence were inducted onto naltrexone and randomly assigned to either a standard (ST) group, with monthly medical monitoring visits, or an enhanced (EN) group in which participants received counseling and educational interventions three times per week. EN group participants took more study medication, were retained in treatment longer, used less opioids while in treatment and showed greater improvement on a number of psychological/affective dimensions. The improved performance of the EN group was relatively short‐lived as there were no significant group differences at 6‐ or 12‐month post‐admission follow‐up points.