Abuse Treatment Clinical Trials Network Research Articles

Transdisciplinary collaboration and endorsement of pharmacological and psychosocial evidence-based practices by medical and psychosocial substance abuse treatment providers in the United States

Aims: To examine the relative contribution of providers’ professional affiliation (medical vs. non-medical), involvement in research, and training needs for associations with endorsement of the following evidence-based practices (EBPs): (1) pharmacological – buprenorphine treatment and (2) psychosocial – Cognitive Behavioural Therapy (CBT).Methods: Secondary analysis from a 2008 survey of a national sample (n = 571) of substance abuse treatment providers (medical, social workers, psychologists and counsellors) affiliated with the United States National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network. Multivariate linear regression models to analyze cross-sectional survey data.Findings: Results demonstrated that medical providers and providers with previous research involvement more strongly endorsed the effectiveness of buprenorphine over CBT. Compared to medical providers, psychosocial providers more strongly endorsed CBT. There was a positive association between needing training in rapport with patients and endorsement of buprenorphine and a negative association with CBT. There was a positive association between needing training in behavioural management and needs assessment and endorsement of CBT.Conclusions: Results underscore the importance of providers’ involvement in research and the need for training medical and non-medical providers in practice areas that can purposely enhance their use of pharmacological and psychosocial EBPs.

Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study

BackgroundPrescription opioid dependence is a growing problem, but little research exists on its treatment, including patient characteristics that predict treatment outcome. MethodsA secondary analysis of data from a large multisite, randomized clinical trial, the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study (POATS) was undertaken to examine baseline patient characteristics (N=360) associated with success during 12-week buprenorphine/naloxone treatment for prescription opioid dependence. Baseline predictor variables included self-reported demographic and opioid use history information, diagnoses assessed via the Composite International Diagnostic Interview, and historical opioid use and related information from the Pain And Opiate Analgesic Use History. ResultsIn bivariate analyses, pre-treatment characteristics associated with successful opioid use outcome included older age, past-year or lifetime diagnosis of major depressive disorder, initially obtaining opioids with a medical prescription to relieve pain, having only used opioids by swallowing or sublingual administration, never having used heroin, using an opioid other than extended-release oxycodone most frequently, and no prior opioid dependence treatment. In multivariate analysis, age, lifetime major depressive disorder, having only used opioids by swallowing or sublingual administration, and receiving no prior opioid dependence treatment remained as significant predictors of successful outcome. ConclusionsThis is the first study to examine characteristics associated with treatment outcome in patients dependent exclusively on prescription opioids. Characteristics associated with successful outcome after 12 weeks of buprenorphine/naloxone treatment include some that have previously been found to predict heroin-dependent patients’ response to methadone treatment and some specific to prescription opioid-dependent patients receiving buprenorphine/naloxone.

A Comparison of Buprenorphine Taper Outcomes Between Prescription Opioid and Heroin Users

Dependence on prescription opioids (PO) is a growing problem. Although most research with buprenorphine has focused on heroin-dependent populations, we hypothesize that individuals dependent on PO display characteristics that may predict different outcomes in treatment, particularly in short-term taper procedures in which comorbidities such as pain conditions may complicate taper. This secondary data analysis examined differences in outcomes between PO users (n = 90) and heroin users (n = 426) after a buprenorphine taper. Data were collected in a multisite randomized clinical trial conducted by the National Drug Abuse Treatment Clinical Trials Network at 11 study sites across the United States. After a 4-week buprenorphine induction/stabilization phase, 516 opioid-dependent individuals were randomized into 1 of 2 taper lengths (7 vs 28 days) to assess the association between taper length and outcome. The primary outcome was measured by urine drug test for opioids at the end of the taper period. Craving, withdrawal, and buprenorphine dose were also examined. After controlling for baseline demographic and drug use differences between the opioid use groups, results indicate that a higher percentage of the PO group (49%) provided an opioid-free urine drug specimen at the end of taper compared with the heroin group (36%; χ(2)(1) = 6.592, P < 0.010). Short-term taper is not recommended as a stand-alone treatment; however, patients may taper from buprenorphine as part of a treatment plan. Despite greater comorbidity, PO users seem to have favorable taper outcomes compared with heroin users. Further studies are required to examine longer-term treatment outcomes.

Clinician attitudes, social norms and intentions to use a computer-assisted intervention

The National Drug Abuse Treatment Clinical Trials Network (CTN) works to bridge the gap between research and practice and tested a Web-delivered psychosocial intervention (the Therapeutic Education System, TES) in 10 community treatment centers. Computer-assisted therapies, such as Web-delivered interventions, may improve the consistency and efficiency of treatment for alcohol and drug use disorders. Prior to the start of the study, we surveyed counselors (N=96) in participating treatment centers and assessed counselor attitudes, perceived social norms and intentions to use a Web-delivered intervention. Analysis of the intention to adopt a Web-delivered intervention assessed the influence of attitudes and perceived social norms. Perceived social norms were a significant contributor to clinician intention to adopt Web-based interventions while attitude was not. To promote successful implementation, it may be helpful to create social norms supportive of computer-assisted therapies.

Assessing fidelity of treatment delivery in group and individual 12-step facilitation

Twelve step facilitation (TSF) is an emerging, empirically supported treatment, the study of which will be strengthened by rigorous fidelity assessment. This report describes the development, reliability and concurrent validity of the Twelve Step Facilitation Adherence Competence Empathy Scale (TSF ACES), a comprehensive fidelity rating scale for group and individual TSF treatment developed for the National Drug Abuse Treatment Clinical Trials Network study, Stimulant Abuser Groups to Engage in 12-Step. Independent raters used TSF ACES to rate treatment delivery fidelity of 966 (97% of total) TSF group and individual sessions. TSF ACES summary measures assessed therapist treatment adherence, competence, proscribed behaviors, empathy and overall session performance. TSF ACES showed fair to good overall reliability; weighted kappa coefficients for 59 co-rated sessions ranged from .31 to 1.00, with a mean of .69. Reliability ratings for session summary measures were good to excellent (.69–.91). Internal consistency for the instrument was variable (.47–.71). Relationships of the TSF ACES summary measures with each other, as well as relationships of the summary measures with a measure of therapeutic alliance provided support for concurrent and convergent validity. Implications and future directions for the use of TSF ACES in clinical trials and community treatment implementation are discussed.

Evaluating brief screeners to discriminate between drug use disorders in a sample of treatment-seeking adults

ObjectiveThe objective was to identify a potential core set of brief screeners for the detection of individuals with a substance use disorder (SUD) in medical settings. MethodData were from two multisite studies that evaluated stimulant use outcomes of an abstinence-based contingency management intervention as an addition to usual care (National Drug Abuse Treatment Clinical Trials Network trials 006–007). The sample comprised 847 substance-using adults who were recruited from 12 outpatient substance abuse treatment settings across the United States. Alcohol and drug use disorders were assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Checklist. Data were analyzed by factor analysis, item response theory (IRT), sensitivity and specificity procedures. ResultsComparatively prevalent symptoms of dependence, especially inability to cut down for all substances, showed high sensitivity for detecting an SUD (low rate of false negative). IRT-defined severe (infrequent) and low discriminative items, especially withdrawal for alcohol, cannabis and cocaine, had low sensitivity in identifying cases of an SUD. IRT-defined less severe (frequent) and high discriminative items, including inability to cut down or taking larger amounts than intended for all substances and withdrawal for amphetamines and opioids, showed good-to-high values of area under the receiver operating characteristic curve in classifying cases and noncases of an SUD. ConclusionFindings suggest the feasibility of identifying psychometrically reliable substance dependence symptoms to develop a two-item screen for alcohol and drug disorders.

Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience

Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN’s primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data.

Web-based, psychosocial treatment for substance use disorders in community treatment settings.

The purpose of this multisite clinical trial was to evaluate the effectiveness of a web-based version of the Community Reinforcement Approach, plus motivational incentives, within community-based, outpatient substance abuse treatment. This ongoing study is being conducted within the National Drug Abuse Treatment Clinical Trials Network, funded by the National Institute on Drug Abuse. Midway through the enrollment of 500 participants, the study is being implemented in 10 treatment programs across the United States. Information is provided on design, sample, intervention and technology, and preliminary lessons learned.

Alcohol and drug dependence symptom items as brief screeners for substance use disorders: Results from the Clinical Trials Network

AimTo address an urgent need for screening of substance use problems in medical settings, we examined substance-specific dependence criteria as potential brief screeners for the detection of patients with a substance use disorder (SUD). MethodsThe sample included 920 opioid-dependent adults who were recruited from outpatient treatment settings at 11 programs in 10 U.S. cities and who completed intake assessments of SUDs for a multisite study of the National Drug Abuse Treatment Clinical Trials Network (CTN003). Data were analyzed by factor analysis, item response theory (IRT), sensitivity, and specificity procedures. ResultsAcross all substances (alcohol, amphetamines, cannabis, cocaine, sedatives), withdrawal was among the least prevalent symptoms, while taking large amounts and inability to cut down were among the most prevalent symptoms. Items closely related to the latent trait of a SUD showed good-to-high values of area under the receiver operating characteristic curve in identifying cases of a SUD; IRT-defined severe and less discriminative items exhibited low sensitivity in identifying cases of a SUD (withdrawal for all substances; time using for alcohol and sedatives; giving up activities for sedatives). ConclusionsStudy results suggest that withdrawal and time using are much less reliable indicators for a SUD than taking larger amounts than intended and inability to cut down and that the latter two items should be studied further for consideration in developing a simplified tool for screening patients for SUDs in medical settings. These findings have implications for the use of common health indicators in electronic health records systems to improve patient care.

Injection behaviors among injection drug users in treatment: The role of hepatitis C awareness

BackgroundInjection drug use (IDU) is a primary vector for blood-borne infections. Awareness of Hepatitis C virus (HCV) infection status may affect risky injection behaviors. This study determines the prevalence of risky injection practices and examines associations between awareness of positive HCV status and risky injection behaviors. MethodsWe surveyed individuals seeking treatment for substance use at 12 community treatment programs as part of a national HIV screening trial conducted within the National Drug Abuse Treatment Clinical Trials Network. Participants reported socio-demographic characteristics, substance use, risk behaviors, and HCV status. We used multivariable logistic regression to test associations between participant characteristics and syringe/needle sharing. ResultsThe 1281 participants included 244 (19.0%) individuals who reported injecting drugs in the past 6months and 37.7% of IDUs reported being HCV positive. During the six months preceding baseline assessment, the majority of IDUs reported obtaining sterile syringes from pharmacies (51.6%) or syringe exchange programs (25.0%), but fewer than half of IDUs always used a sterile syringe (46.9%). More than one-third (38.5%) shared syringe/needles with another injector in the past 6months. Awareness of positive HCV vs. negative/unknown status was associated with increased recent syringe/needle sharing (aOR 2.37, 95% CI 1.15, 4.88) in multivariable analysis. ConclusionsRisky injection behaviors remain prevalent and awareness of HCV infection was associated with increased risky injection behaviors. New approaches are needed to broadly implement HCV prevention interventions for IDUs seeking addiction treatment.

A multilevel approach to predicting community addiction treatment attitudes about contingency management

Adoption of contingency management (CM) by the addiction treatment community is limited to date despite much evidence for its efficacy. This study examined systemic and idiographic staff predictors of CM adoption attitudes via archival data collected from treatment organizations affiliated with the National Drug Abuse Treatment Clinical Trials Network. Multilevel modeling analyses evaluated potential predictors from organizational, treatment unit, and workforce surveys. Among these were individual and shared perceptions of staff concerning aspects of their clinic culture and climate. Modeling analyses identified three systemic predictors (clinic provision of opiate agonist services, national accreditation, and lesser shared perception of workplace stress) and five idiographic predictors (staff with a graduate degree, longer service tenure, managerial position, e-communication facility, and openness to change in clinical procedures). Findings are discussed as they relate to extant literature on CM attitudes and established implementation science constructs, and their practical implications are discussed.

Brief strategic family therapy versus treatment as usual: Results of a multisite randomized trial for substance using adolescents.

To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to TAU with a multiethnic sample of adolescents (213 Hispanic, 148 White, and 110 Black) referred for drug abuse treatment at 8 community treatment agencies nationwide. Randomization encompassed both adolescents' families (n = 480) and the agency therapists (n = 49) who provided either TAU or BSFT services. The primary outcome was adolescent drug use, assessed monthly via adolescent self-report and urinalysis for up to 1 year post randomization. Secondary outcomes included treatment engagement (≥2 sessions), retention (≥8 sessions), and participants' reports of family functioning 4, 8, and 12 months following randomization. No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use. However, the median number of days of self-reported drug use was significantly higher, χ2(1) = 5.40, p < .02, in TAU (Mdn = 3.5, interquartile range [IQR] = 11) than BSFT (Mdn = 2, IQR = 9) at the final observation point. BSFT was significantly more effective than TAU in engaging, χ2(1) = 11.33, p < .001, and retaining, χ2(1) = 5.66, p < .02, family members in treatment and in improving parent reports of family functioning, χ2(2) = 9.10, p < .011. We discuss challenges in treatment implementation in community settings and provide recommendations for further research.

Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: An example from the NIDA Clinical Trials Network

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.

Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials

IntroductionHistorically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants.PurposeThe examination of gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials.MethodsReports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s).ResultsAnalysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants.ConclusionThese results are based on a large sample of patients with substance use disorders recruited from a treatment-seeking population. The findings demonstrate that younger participants are less likely than older adults to be retained in clinical trials.

Hepatitis B virus and hepatitis C virus services offered by substance abuse treatment programs in the United States

Although substance abuse treatment programs are important contact points for providing health services for hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, availability of services in these programs has not been well characterized. This study evaluated the spectrum of HBV and HCV services offered by substance abuse treatment programs within the National Drug Abuse Treatment Clinical Trials Network. Our survey of substance abuse treatment program administrators covered availability of testing for HBV and HCV; hepatitis A virus (HAV) and HBV immunization; and HCV medical and nonmedical services. There were also questions covering clarity of guidelines for HBV and HCV testing and HAV and HBV immunization. Differences between methadone and nonmethadone programs were examined. Despite the importance of substance abuse in sustaining the hepatitis epidemics, few programs offer comprehensive HBV and HCV testing or HCV health care services. Interventions to improve access to hepatitis services for substance-abusing patients are needed.

Depressive Symptoms, Substance Use, and HIV-Related High-Risk Behaviors Among Opioid-Dependent Individuals: Results From the Clinical Trials Network

The sample included 343 opioid-dependent adults enrolled in two national multisite studies of the National Drug Abuse Treatment Clinical Trials Network (CTN001-002). Opioid-dependent individuals were recruited from 12 sites across the United States from January 2001 to July 2002. We examined associations between depressive symptoms, co-occurring substance use (i.e., the use of substances other than opioids), and HIV-related sexual and injection risk behaviors. Data were collected using the Addiction Severity Index and the HIV Risk Behavior Scale, and analyzed using linear regression. Depressive symptoms were associated with an increased level of injection risk behaviors but were not associated with risky sexual behaviors. The co-occurring use of amphetamines also increased the likelihood of risky sexual behaviors. The study limitations and clinical implications are noted. The study was funded by the U.S. National Institute on Drug Abuse.

The Substance Abuse Counseling Workforce: Education, Preparation, and Certification

ABSTRACT The National Drug Abuse Treatment Clinical Trials Network (CTN) is an alliance of drug abuse treatment programs and research centers testing new interventions and implementation factors for treating alcohol and drug use disorders. A workforce survey distributed to those providing direct services in 295 treatment units in the CTN obtained responses from 1750 individuals with a job title of counselor (n = 1395) or counselor supervisor (n = 355). A secondary analysis compares and describes both groups. Supervisors were more likely to be licensed or certified. Master's degrees were more common among counselors in outpatient and methadone programs. Counselors in residential settings tended to be on the job fewer years. Finally, higher education was associated with greater familiarity with and acceptance of evidence-based practices.

Site Selection in Community-Based Clinical Trials for Substance Use Disorders: Strategies for Effective Site Selection

Background: The importance of conducting substance use disorder treatment research in real-world settings is now well recognized. While this approach to clinical trials research offers a variety of benefits, challenges also arise. Selecting high-quality sites to participate is critical to recruitment, retention, and overall trial performance when conducting multi-site, community-based clinical trials of treatments for substance use disorders. Objectives: Over the past 10 years, the National Institute on Drug Abuse-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN) has strived to conduct high-quality, well-managed clinical trials. This includes developing methods for site selection to be used by investigators conducting CTN trials. Methods: We review site selection strategies from two community-based multi-site clinical trials conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network. Results: Issues relevant to site selection include the clinical trial design, availability of appropriate clinical population, and organizational attributes of potential clinical research sites. Site selection strategies include reviewing regional epidemiologic data, collecting standard site selection surveys, evaluating clinic data on existing patient populations, and site selection interviews and visits. Conclusion: This article describes considerations for selecting research sites and identifies specific strategies to employ when selecting community-based sites for participation in clinical trials.

Standardized Patient Walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: Common Challenges to Protocol Implementation

Background: Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. Objectives: Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Method: Actors portrayed clients and “walked through” study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials. Results: Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns. Conclusions and Scientific Significance: Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

Gender Research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: A Summary of Findings

Background: The National Institute of Drug Abuse’s National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable subgroups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. Objectives: To review gender-related findings from published CTN clinical trials and related studies from January 2000 to March 2010. Methods: CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors; or implemented gender-specific protocols. The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized controlled trials in community settings, of which 4 have been gender-specific. Results: This article summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. Conclusions: These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance-using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. Scientific Significance: To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods.