Qualitative Urine Drug Screens Research Articles

Evaluation of adherence monitoring in buprenorphine treatment: A pilot study using timed drug assays to determine accuracy of testing.

Buprenorphine is effective at reducing relapse to opioid misuse, morbidity and mortality in opioid-dependent patients. Urine drug screening (UDS) to assess adherence is used routinely in opioid agonist treatment (OAT). The primary aim of this study was to determine factors which may be associated with a negative qualitative urine drug screen for buprenorphine in OAT patients. This prospective pilot study was conducted at a tertiary addiction medicine centre. Twenty participants on stable treatment underwent supervised administration of sublingual buprenorphine. Matched urine and blood samples were collected prior to and 2, 4 and 6 hours after buprenorphine administration. Qualitative urine drug screen results were obtained using gas chromatography-mass spectrometry (GC-MS), while quantitative blood and urine results were obtained using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). Qualitative urine assay yielded a negative result for buprenorphine in 57% of tested samples. The median concentration of urinary buprenorphine was 167 mcg/L (range: 2-1730 mcg/L). Thirty percent of all blood samples did not detect buprenorphine (range 0-18 mcg/L). Positive qualitative urine drug screen results were associated with higher urine (343 mcg/L compared with 75 mcg/L; P < .05) and blood (4mcg/L compared with 2mcg/L; P < .05) buprenorphine concentrations. Median urine concentrations of buprenorphine were highest at 2hours and were higher in participants receiving CYP3A4 inhibitors. Interpretation of qualitative urine drug screens to assess adherence in OAT is complex. Poor adherence with treatment cannot be assumed in patients returning a negative qualitative GC-MS urine drug screen.

Cost and Efficacy Assessment of an Alternative Medication Compliance Urine Drug Testing Strategy

This study investigates the frequency at which quantitative results provide additional clinical benefit compared to qualitative results alone. A comparison between alternative urine drug screens and conventional screens including the assessment of cost-to-payer differences, accuracy of prescription compliance or polypharmacy/substance abuse was also included. In a reference laboratory evaluation of urine specimens from across the United States, 213 urine specimens with provided prescription medication information (302 prescriptions) were analyzed by two testing algorithms: 1) conventional immunoassay screen with subsequent reflexive testing of positive results by quantitative mass spectrometry; and 2) a combined immunoassay/qualitative mass-spectrometry screen that substantially reduced the need for subsequent testing. The qualitative screen was superior to immunoassay with reflex to mass spectrometry in confirming compliance per prescription (226/302 vs 205/302), and identifying non-prescription abuse (97 vs 71). Pharmaceutical impurities and inconsistent drug metabolite patterns were detected in only 3.8% of specimens, suggesting that quantitative results have limited benefit. The percentage difference between the conventional testing algorithm and the alternative screen was projected to be 55%, and a 2-year evaluation of test utilization as a measure of test order volume follows an exponential trend for alternative screen test orders over conventional immunoassay screens that require subsequent confirmation testing. Alternative, qualitative urine drug screens provide a less expensive, faster, and more comprehensive evaluation of patient medication compliance and drug abuse. The vast majority of results were interpretable with qualitative results alone indicating a reduced need to automatically reflex to quantitation or provide quantitation for the majority of patients. This strategy highlights a successful approach using an alternative strategy for both the laboratory and physician to align clinical needs while being mindful of costs.

Use of the urine drug screen in psychiatry emergency service.

This study investigates if the routine use of the urine drug screen offers any diagnostic or management benefit in the assessment and treatment of psychiatry patients in a suburban psychiatry emergency service. Data was collected retrospectively from consecutive patients 18 years and above, who presented to a large suburban hospital emergency department and had a urine drug screen ordered in the emergency department. A total of 111 patients, (with mean age of participants being 34.9 years, SD 10.2 years, minimum 18-maximum 62 years, 62.2% (69/111) were male) met the inclusion criteria. The most common drug group identified was benzodiazepines (59.5%; 66/111), followed by cannabis (40.5%; 45/111). Other drugs were identified at much lower levels, including amphetamines (9.0%; 10/111), opiates (4.5%; 5/111) and methadone (0%; 0/111). For most individuals only one drug was detected (55.9%; 62/111), with equal numbers (18.9%) with either zero or two drugs identified by a urine drug screen. Fewer patients had three drugs on a urine drug screen (5.4%; 6/111) or four (0.9%; 1/111). Qualitative urine drug screens provide limited additional information compared to history taking and has minimal impact on clinical management decisions in a psychiatry emergency service.

Melanotan II injection resulting in systemic toxicity and rhabdomyolysis

Introduction. Melanotan products are currently purchased over the Internet and are designed to induce melanogenesis to create sunless tanning as well are used as sexual stimulants. We report a novel case of systemic toxicity with sympathomimetic excess and rhabdomyolysis after use of Melanotan II. Case report. A 39 year-old Caucasian male injected subcutaneously 6 mg of Melanotan II purchased over the Internet in an attempt to darken his skin during wintertime. This dose was six times the recommended starting dose per the patient. In the emergency department two hours post injection, he complained of diffuse body aches, sweating, and a sensation of anxiety. Vital signs included BP 151/85 mmHg, HR 130 bpm that peaked at 146 bpm, and temperature of 97.8°F. Physical exam demonstrated a restless and anxious appearing male with mydriasis, diaphoresis, tachycardia, and diffuse muscle tremors. Pertinent laboratory values were creatinine 2.25 mg/dL, CPK 1760 IU/L, troponin 0.23 ng/mL, WBC 19.1 k/μL. Urinalysis demonstrated 3 + blood with red cell casts but 0–2 RBC/hpf. Qualitative urine drug screen was negative for metabolites of cocaine and amphetamines but positive for opiates. The patient received benzodiazepines for agitation and anxiety and had improvement in his symptoms. He was admitted to the ICU and during hospitalization his CPK elevated to 17773 IU/L 12 hours later. He continued to receive intravenous fluids with sodium bicarbonate for rhabdomyolysis and his CPK decreased to 2622 IU/L with improvement of creatinine to 1.23 mg/dL upon discharge from the ICU after 3 days. The substance, which he injected, was analyzed via mass spectrometry and was confirmed to be Melanotan II when compared with an industry purchased standard sample. Discussion. Melanotan products are purchased via the Internet and have three main formulations (Melanotan I, Melanotan II, and bremelanotide). Melanotan I increases melanogenesis and eumelanin content to produce sunless tanning. Melanotan II also increases skin pigmentation but also produces spontaneous penile erections and sexual stimulation. Bremelanotide is a variation of Melanotan II that is specifically designed for sexual stimulation. This unique case highlights the potential of systemic toxicity with sympathomimetic excess, rhabdomyolysis, and renal dysfunction from Melanotan II use. Conclusion. Melanotan II use resulted in systemic toxicity including apparent sympathomimetic symptoms, rhabdomyolysis, and renal dysfunction.

Nonfatal tramadol overdose may cause false-positive phencyclidine on Emit-II assay

False-positive results are a common finding with qualitative urine drug screens. This report describes 2 patients with positive phencyclidine (PCP) screens using the Emit II Plus Drugs-of-Abuse Test (Siemens Healthcare Diagnostics, Inc, Tarrytown, NY) after tramadol ingestion. Our first case was a 43-year-old woman with a history of bipolar disorder who presented to the emergency department(ED) for medical clearance after ingesting an unknown amount of tramadol. Her urine drugs-of-abuse screen was positive for PCP. A comprehensive gas chromatography/mass spectrometry qualitative urine drug screen demonstrated valproic acid metabolites, nicotine, gabapentin, benztropine, and a large peak of tramadol. Our second case was a 3-year-old boy with a medical history of previous ingestions presented to the ED for altered mental status and suspected ingestion. His urine drugs-of-abuse screen was positive for PCP. A comprehensive gas chromatography/mass spectrometry qualitative urine drug screen demonstrated a large peak of tramadol. Molecular similarity analysis can predict cross-reactivity of drug of abuse and therapeutic drug monitoring assays. This computational analysis demonstrated that tramadol and its metabolite possess enough similarity to PCP to produce positives due to interaction with the assay antibody (or antibodies). Tramadol and its metabolites can cause a false-positive Emit II+ PCP screen, and clinicians should use caution when interpreting urine drugs-of-abuse screens that use immunoassays.

False-Positive Urine Phencyclidine Immunoassay Screen Result Caused by Interference by Tramadol and Its Metabolites

Phencyclidine is one of the drugs of abuse included in qualitative urine drug screens that are frequently ordered in the emergency department despite concerns about specificity and clinical utility. Many drugs have been described to cause false-positive results for phencyclidine. We present 2 cases of false-positive phencyclidine qualitative urine drug screen results in patients with seizures from tramadol misuse or abuse. The involvement of tramadol and its active metabolite, N-desmethyltramadol, was confirmed by in vitro testing. These cases illustrate that tramadol and its metabolites can trigger a false-positive phencyclidine urine drug screen result in nonfatal cases and highlight the lack of specificity of the phencyclidine qualitative urine drug screen.

Determining the Primary Endpoint for a Stimulant Abuse Trial: Lessons Learned from STRIDE (CTN 0037)

Background: No consensus is available for identifying the best primary outcome for substance use disorder trials, making interpretation across trials difficult. Abstinence is the most desirable treatment outcome although a wide variety of other endpoints have been used. Objectives: This report provides a framework for determining an optimal primary endpoint and the relevant measurement approach for substance use disorder treatment trials. The framework was developed based on a trial for stimulant abuse using exercise as an augmentation treatment, delivered within the NIDA Clinical Trials Network. The use of a common endpoint across trials will facilitate comparisons of treatment efficacy. Methods: Primary endpoint options in existing substance abuse studies were evaluated. This evaluation included surveys of the literature for endpoints and measurement approaches, followed by assessment of endpoint choices against study design issues, population characteristics, tests of sensitivity, and tests of clinical meaningfulness. Conclusion: We concluded that the best current choice for a primary endpoint is percent days abstinent, as measured by the Time Line Follow Back interview conducted three times a week with recall aided by a take-home Substance Use Diary. To improve the accuracy of the self-reported drug use, the results of qualitative urine drug screens will be used in conjunction with the Time Line Follow Back results. Scientific Significance: There is a need for a standardized endpoint in this field to allow for comparison across treatment studies, and we suggest that the recommended candidate endpoint be considered. However, the study design and goals ultimately must guide the final decision.

Modafinil for the treatment of methamphetamine dependence

Aim Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo. Methods This was a randomized, double-blind, placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Eight outpatient substance abuse treatment clinics participated in the study. There were 210 treatment-seekers randomized, who all had a DSM-IV diagnosis of methamphetamine dependence; 68 participants to placebo, 72 to modafinil 200 mg, and 70 to modafinil 400 mg, taken once daily on awakening. Participants came to the clinic three times per week for assessments, urine drug screens, and group psychotherapy. The primary outcome measure was a methamphetamine non-use week, which required all the week's qualitative urine drug screens to be negative for methamphetamine. Results Regression analysis showed no significant difference between either modafinil group (200 or 400 mg) or placebo in change in weekly percentage having a methamphetamine non-use week over the 12-week treatment period ( p = 0.53). Similarly, a number of secondary outcomes did not show significant effects of modafinil. However, an ad-hoc analysis of medication compliance, by urinalysis for modafinil and its metabolite, did find a significant difference in maximum duration of abstinence (23 days vs. 10 days, p = 0.003), between those having the top quartile of compliance (>85% of urines were positive for modafinil, N = 36), and the lower three quartiles of modafinil 200 and 400 mg groups ( N = 106). Conclusions Although these data suggest that modafinil, plus group behavioral therapy, was not effective for decreasing methamphetamine use, the study is probably inconclusive because of inadequate compliance with taking medication.

Atomoxetine for treatment of marijuana dependence: A report on the efficacy and high incidence of gastrointestinal adverse events in a pilot study

Marijuana users consistently demonstrate impairments in attention, executive function and response inhibition, which resemble deficits seen in attention deficit hyperactivity disorder (ADHD). We hypothesized that targeting the cognitive deficits associated with chronic marijuana use through ADHD medications may help identify a therapeutic agent for marijuana dependence. Thirteen subjects participated in an 11-week open label study to determine the feasibility, safety and tolerability of atomoxetine for individuals seeking treatment for marijuana dependence. The Time-Line Follow-Back measured marijuana use 90 days prior to study entry (p-TLFB) and weekly during the study (s-TLFB) along with weekly qualitative urine drug screen (UDS). For the eight subjects who completed the trial, the TLFB data showed a trend toward reduction in use with an increase in percent days abstinent ( p = 0.06). Analysis of weekly UDSs did not confirm the TLFB trend with 94% of all possible UDSs positive for THC through out the study. Marijuana dependent subjects taking atomoxetine experienced an inordinate number of gastrointestinal (GI) adverse events. Overall, 10 of 13 subjects (77%) experienced a mild to moderate GI adverse event defined as nausea, vomiting, dyspepsia, and loose stools. Atomoxetine is of limited utility in the treatment of cannabis dependence and is associated with clinically significant GI adverse events.

The utility of toxicologic analysis in children with suspected ingestions.

To evaluate the usefulness of toxicologic studies on the management of children with suspected ingestions. Prospective, consecutive case series. Two tertiary care children's hospital emergency departments. All children < or =18 years of age presenting with a suspected ingestion. Pediatric emergency physicians completed a 14-point questionnaire on each identified patient that included demographics, signs, and symptoms, and if applicable, the extent of drug analysis performed. Pre-test and post-test utility values were determined by the ordering physician using an 11-point scale (0 = least valuable, 10 = most valuable). Physicians also assessed how positive or negative drug analyses affected patient management. Two hundred twenty patients met study criteria. Median age was 5 years, with males making up 53% of patients. Drug analysis was ordered in 72% (158/220) of cases, with 59% of these tests obtained for a history of ingestion and 27% obtained for altered mental status (AMS). The most common suspected ingestions were acetaminophen and cold preparations. Seventy-eight of 158 (49%) patients had positive toxicology tests, with 17 unsuspected findings. Patient management was affected in 53/158 (34%; 95% CI, 27-41%) cases. Unsuspected findings affecting management were found in only 4/158 (3%; 95% CI, 1-6%) cases. Significant differences in pre-test and post-test utility values occurred for serum assays (mean difference +0.4, P = 0.008), patients presenting with AMS (mean difference -0.8, P = 0.005), and patients having a negative drug test (mean difference -0.5, P = 0.003). Although negative drug analysis gave the physician reassurance in 39/80 (49%; 95% CI, 38-60%) cases, patient management was altered in only 8/80 (10%; 95% CI, 5-18%) cases. Seventy-two percent of children presenting with suspected drug ingestions had toxicologic analysis performed as part of their evaluation. Analysis was most valuable to physicians when evaluation of overdoses required serum drug levels. Qualitative urine drug screens provided minimal useful information. Unexpected findings on urine drug screening leading to changes in management were uncommon.