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Abstract: To advance understanding of medication treatments for opioid use disorder (OUD), identification of distinct subgroups and factors associated with differential treatment response is critical. This study examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted into) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory. This secondary analysis of data from CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT), used growth mixture models to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in the original 24-week randomized controlled trial of BUP-NX (n=281) or XR-NTX (n=254). Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes. Conclusions: Findings highlight the significant heterogeneity of opioid use during a randomized controlled trial of BUP-NX and XR-NTX and several factors associated with longitudinal patterns of opioid use that can be effectively targeted in the context of active clinician monitoring and adaptive treatment strategies tailored to patient needs. Policies that increase access and adherence to medication treatment, alongside an understanding of the unique patterns of medication response and the factors that influence it, will be critical in reducing the current opioid crisis. Related protocols: CTN-0051

Abstract:

Opioid use disorder (OUD) is a chronic, relapsing condition with severe negative health consequences. Previous studies have reported that 5-year abstinence is a good predictor of reduced likelihoods of relapse, but factors that shape long-term opioid abstinence are poorly understood.

The present study is based on data from a prospective study of 699 adults with OUD who had been randomized to either methadone or buprenorphine/naloxone and who were followed for at least 5 years (CTN-0050, Long Term Follow-Up of START Patients). During the 5 years prior to the participants’ last follow-up interview, 232 (33.2%) had achieved 5-year abstinence from heroin. Of those 232, 145 (20.7% of the total) had remained abstinent from both heroin and other opioids (e.g., hydrocodone, oxycodone, other opioid analgesics, excluding methadone or buprenorphine). Compared to non-abstinent individuals, those in both categories of opioid abstinence had lower problem severity in health and social functioning at the final follow-up. Logistic regression results indicated that cocaine users and injection drug users were less likely to achieve 5-year heroin abstinence, whereas Hispanics (vs. whites) and those treated in clinics on the West Coast (vs. East) were less likely to achieve 5-year abstinence from heroin and other opioids. For both abstinence category groups, abstinence was positively associated with older age at first opioid use, lower impulsivity, longer duration of treatment for OUD, and greater social support.

Conclusions: Given the current opioid crisis, this study contributes valuable information by identifying correlates of long-term opioid abstinence that are important for efforts to facilitate stable recovery. Reducing cocaine use and injection drug use and increasing social support and retention in treatment may help maintain long-term abstinence from opioids among individuals treated with agonist pharmacotherapy.

Related protocols: CTN-0050

Abstract:

Currently, no pharmacogenetic tests for selecting an opioid-dependence pharmacotherapy have been approved by the U.S. Food and Drug Administration. This study aimed to determine the effects of variants in 11 genes on dropout rate and dose in patients receiving methadone or buprenorphine/naloxone. Variants in 6 pharmacokinetic genes (CYP1A2, CYP2B6, CYP2C19, CYP2C9, CYP2D6, CYP3A4) and 5 pharmacodynamic genes (HTR2A, OPRM1, ADRA2A, COMT, SLC6A4) were genotyped in samples from a 24-week, randomized, open-label trial of methadone and buprenorphine/naloxone for the treatment of opioid dependence (n=764; 68.7% male). Genotypes were then used to determine the metabolism phenotype for each pharmacokinetic gene. Phenotypes or genotypes for each gene were analyzed for association with dropout rate and mean dose.

Results found that the genotype for 5-HTTLPR in the SLC6A4 gene was nominally associated with dropout rate when the methadone and buprenorphine/naloxone groups were combined. When the most significant variants associated with dropout rate were analyzed using pairwise analyses, SLC6A54 (5-HTTLPR) and COMT (Val158Met; rs4860) had nominally significant associations with dropout rate in methadone patients. None of the genes analyzed in the study were associated with mean dose of methadone or buprenorphine/naloxone.

Conclusions: This study suggests that functional polymorphisms related to synaptic dopamine or serotonin levels may predict dropout rates during methadone treatment. Patients with the S/S genotype at 5-HTTLPR in SLC6A4 or the Val/Val genotype at Val158Met in COMT may require additional treatment to improve their chances of completing addiction treatment. Replication in other methadone patient populations will be necessary to ensure the validity of these findings.

Related protocols: CTN-0027, CTN-0027-A-1

Abstract:

The mu-opioid receptor (MOR) is the primary target of methadone and buprenorphine. The primary neuronal transcript of the OPRM1 gene, MOR-1, contains a ~13kb 3′ untranslated region with five common haplotypes in European-Americans. We analyzed the effects of these haplotypes on the percentage of opioid positive urine tests in European-Americans (n=582) during a 24-week, randomized, open-label trial of methadone or buprenorphine/naloxone (Suboxone) for the treatment of opioid dependence. A single haplotype, tagged by rs10485058, was significantly associated with patient urinalysis data in the methadone treatment group. Methadone patients with the A/A genotype at rs10485058 were less likely to have opioid-positive urine drug screens than those in the combined A/G and G/G genotypes group (relative risk = 0.76, 95% confidence intervals = 0.73-0.80, P=0.0064). Genotype at rs10485058 also predicted self-reported relapse rates in an independent population of Australian patients of European descent (n=1215) who were receiving opioid substitution therapy (P=0.003). In silico analysis predicted that miR-95-3p would interact with the G, but not the A allele of rs10485058, suggesting a potential mechanism for the observed pharmacogenetic effect.

Conclusions: These findings suggest that selection of a medication for opioid dependence based on rs10485058 genotype might improve outcomes in this ethnic group.

Related protocols: CTN-0027, CTN-0027-A-1

Abstract:

The multi-site Prescription Opioid Addiction Treatment Study (POATS), conducted by the NIDA Clinical Trials Network, was the largest clinical trial yet conducted with patients dependent on prescription opioids (N=653). In addition to main trial results, the study yielded numerous secondary analyses, and included a 3.5-year follow-up study, the first of its kind with this population. This paper summarizes the POATS design, main outcomes, predictors of outcome, subgroup analyses, the predictive power of early treatment response, and the long-term follow-up study.

POATS examined combinations of buprenorphine-naloxone of varying duration and counseling of varying intensity. The primary outcome analysis showed no overall benefit to adding drug counseling to buprenorphine-naloxone and weekly medical management. Only 7% of patients achieved a successful outcome (abstinence or near-abstinence from opioids) during a 4-week taper and 8-week follow-up; by comparison, 49% of patients achieved success while subsequently stabilized on buprenorphine-naloxone.

Long-term follow-up results were more encouraging, with higher abstinence rates than in the main trial. Patients receiving opioid agonist treatment at the time of follow-up were more likely to have better outcomes, though a sizeable number of patients succeeded without agonist treatment. Some patients initiated risky use patterns, including heroin use and drug injection. A limitation of the long-term follow-up study was the low follow-up rate.

Conclusions: POATS was the first large-scale study of the treatment of prescription opioid dependence; its findings can influence both treatment guidelines and future. In particular, the results of POATS suggest support for an individualized approach to behavioral interventions in the context of buprenorphine-naloxone treatment of prescription opioid use disorders. The fact that some patients benefited from counseling (heroin users who attended sessions regularly, for example) suggests that some patients would do well with just medical management and others should receive additional counseling.

Related protocols: CTN-0030

Abstract:

Buprenorphine-naloxone (BUP-NLX) can be used to manage prescription opioid addiction among persons with chronic pain, but post-treatment relapse is common and difficult to predict. This study, a secondary analysis of data from the CTN’s Prescription Opioid Addiction Treatment Study (POATS), estimated whether changes in pain over time and pain volatility during BUP-NLX maintenance would predict opioid use during the BUP-NLX taper. Study participants, from community clinics affiliated with POATS in 10 U.S. cities, were subjects with chronic pain who entered the BUP-NLX taper phase (N=125), with enrollment occurring from June 2006 to July 2009 (52% male, 88% Caucasian, 31% married). Outcomes were weekly biologically-verified and self-reported opiate use from the 4-week taper phase. Predictors were estimates of baseline severity, rate of change, and volatility in pain from weekly self-reports during the 12-week maintenance phase.

Controlling for baseline pain and treatment condition, increased pain and greater pain volatility predicted greater odds of positive opioid urine screen during BUP-NLX taper. Increased pain and greater pain volatility also predicted greater frequency of self-reported opioid use.

Conclusions: Adults with chronic pain receiving outpatient treatment with buprenorphine-naloxone (BUP-NLX) for prescription opioid addiction have elevated risk for opioid use when tapering off maintenance treatment. Those with relative persistence in pain over time and greater volatility in pain during treatment are less likely to sustain abstinence during BUP-NLX taper. These findings suggest that stabilizing and/or reducing subjective pain prior to discontinuation of BUP-NLX maintenance may be a means to improve treatment outcomes in this population.

Related protocols: CTN-0030

Abstract:

Uncovering heterogeneities in longitudinal patterns (trajectories) of opioid use among individuals with opioid use disorder can increase our understanding of disease progression and treatment responses to improve care. The present study aims to identify distinctive opioid use trajectories and factors associated with those patterns among participants randomized to treatment with methadone (MET) or buprenorphine + naloxone (BUP). Growth mixture modeling was applied to identify distinctive opioid use trajectories among 795 opioid users after their enrollment in CTN-0027 (CTN START trial), a multisite trial during 2006 to 2009, with follow-up interviews conducted during 2011 to 2014 (CTN-0050 START Follow-up trial).

Four distinctive trajectories were identified based on opioid use over the follow-up period: low use (42%), high use (22.3%), increasing use (17.1%), and decreasing use (18.6%). Greater odds of being in the high use group (relative to low use) was associated with Hispanics (relative to African American, odds ratio [OR] 3.21), injection drug use (OR 2.12), higher mental health functioning at baseline (OR 1.23), location on the West Coast (vs. East Coast, OR 2.15), and randomization to BUP (relative to MET, OR 1.53). High use and increasing use groups had greater severity in problems related to drug, employment, legal, and social/family relationships, and worsened mental health functioning at follow-up. Participation in treatment significantly accounted for both within and between-group differences in opioid use.

A very promising finding is that the largest group (more than 40% of the sample) demonstrated a consistently low level of use after entering the medication trial. In contrast, approximately 17% of the participants gradually increased their opioid use after they initially reduced use, and another 19% did not respond well initially, but gradually decreased use over time.

Conclusions: The study findings underscore the importance of keeping opioid-dependent individuals in treatment and making treatment more widely available and accessible. Identifying factors that may account for distinctive opioid use trajectory patterns can further information policy decisions and clinic practice in targeting those at greatest need for opioid treatment.

Related protocols: CTN-0027, CTN-0050

Abstract:

This is the primary outcomes article for CTN-0048.

This study aimed to examine the safety and effectiveness of buprenorphine+naloxone sublingual tablets (BUP, as Suboxone) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.

This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the NIDA Clinical Trials Network (CTN-0048), randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York, and Washington D.C. to 1 of 3 conditions provided with XR-NTX: 4mg/day BUP (BUP4, n=100), 16mg/day BUP (BUP16, n=100), or no buprenorphine (placebo, PLB, n=102).

Participants received pharmacotherapy for 8 weeks, with 3 clinic visits per week. Cognitive Behavioral Therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention, and adverse events.

No group differences were found between groups for the primary outcome (BUP4 vs. PLB, p=0.262; BUP16 vs PLB, p=0.185).). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB (p=0.022, OR=1.71) but not for BUP4 (p=0.105, OR=1.05). No secondary outcome differences across groups were found for adherence, retention, or adverse events.

Conclusions: Although the primary outcome analysis did not detect significant differences in cocaine use between treatment groups, some urine drug screen analyses found that participants randomized to higher dose (16 mg/day) of buprenorphine provided significantly more cocaine-negative urine samples compared to participants randomized to placebo. Furthermore, the medication combination used in this study appeared to be safe with little risk of inducing iatrogenic opioid dependence. The combination of naltrexone and buprenorphine deserves further confirmatory study as pharmacotherapy for cocaine use disorder.

Related protocols: CTN-0048

Abstract:

This is the primary outcomes article for CTN-0050.

This study, a long-term follow-up of patients from the NIDA Clinical Trials Network’s Starting Treatment with Agonist Replacement Therapy (START, CTN-0027), aimed to compare long-term outcomes among participants randomized to buprenorphine (BUP) or methadone (MET), including mortality, opioid use status during/after 60-month follow-up, treatment participation status and retention over the 60-month period, and the effects of each type of opioid replacement treatment (BUP or MET) on level of opioid use over the 60-month period. Follow-up was conducted in 2011-2014 on 1,080 opioid-dependent participants entering 7 opioid treatment programs in the US between 2006-2009 and randomized (within each program) to receive open-label buprenorphine/naloxone or methadone for up to 24 weeks; 795 participants completed in-person interviews (~74% follow-up interview rate) covering, on average, 4.5 years.

Analysis revealed no difference in mortality between the two randomized conditions, with 23 (3.6%) of 630 participants randomized to buprenorphine having died, versus 26 (5.8%) of 450 randomized to methadone. Opioid use at follow-up was higher among participants randomized to buprenorphine relative to methadone (42.8% vs. 31.7% positive opioid urine specimens; 5.8 days vs. 4.4 days of past 30-day heroin use). Opioid use over the follow-up period by randomization condition was also significant, mostly due to less treatment participant among participants randomized to buprenorphine than methadone. Less opioid use was associated with both buprenorphine and methadone treatment (relative to no treatment); no difference was found between the two treatments. Individuals who are white or used cocaine at baseline responded better to methadone than to buprenorphine.

Conclusions: There are few differences in long-term outcomes between buprenorphine and methadone treatment for opioid dependence, and treatment with each medication is associated with a strong reduction in opioid use. This study, the first to follow opioid dependent individuals randomized to two opioid maintenance treatments prospectively over 5 or more years, is instructive about longer term outcomes and poses a challenge to the field to enhance retention in the opioid maintenance treatment. Many individuals with opioid use disorder cycle in and out of maintenance treatment, and this study confirms they show better outcomes when retained in that treatment instead. Efforts are needed, especially in the context of the current opioid epidemic, to improve both BUP and MET treatment retention.

Related protocols: CTN-0027, CTN-0050

Abstract:

The combination of prescription opioid dependence and chronic pain is increasingly prevalent and hazardous to public health. Variability in pain may explain poor prescription opioid addiction treatment outcomes in persons with chronic pain. This secondary analysis of Phase 2 of the NIDA Clinical Trials Network’s multisite “Prescription Opioid Addiction Treatment Study” (POATS), examined pain trajectories and pain volatility in patients with chronic pain receiving treatment for prescription opioid addiction.

Secondary analyses of adults with chronic pain (n=149) who received buprenorphine/naloxone (BUP/NLX) and counseling for 12 weeks in POATS were conducted. Good treatment outcome was defined as urine-verified abstinence from opioids at treatment endpoint (week 12) and during at least 2 of the previous 3 weeks. Pain severity significantly declined over time during treatment (b = -0.36, p < .001). Patients with greater pain volatility were less likely to have a good treatment outcome (odds ratio = 0.55, p < .05), controlling for baseline pain severity and rate of change in pain over time. 1 standard deviation increase in pain volatility was associated with a 44% reduction in the probability of endpoint abstinence.

Conclusions: The significant reduction in subjective pain during treatment provides observational support for the analgesic effects of BUP/NLX in patients with chronic pain and opioid dependence. Patients with greater volatility in subjective pain during treatment have increased risk of returning to opioid use by the conclusion of an intensive treatment with BUP/NLX and counseling. Clinicians providing treatment for co-occurring prescription opioid addiction and chronic pain may want to consider monitoring pain volatility to monitor for risk for poor treatment outcomes and adjust treatment regimens accordingly. Future research should examine underlying mechanisms of pain volatility and identify related therapeutic targets to optimize interventions for prescription opioid addiction and co-occurring chronic pain.

Related protocols: CTN-0030

Abstract:

Induction is a crucial period of opioid addiction treatment. This study aimed to identify buprenorphine/naloxone (BUP) induction patterns and examine their association with outcomes (opioid use, retention, and related adverse events [AEs]). Using data from the NIDA Clinical Trials Network study Starting Treatment with Agonist Replacement Therapies (START) (CTN-0027), this study involved 740 participants inducted on BUP with flexible dosing, receiving treatment in 8 treatment settings. Latent class analysis models detected six distinctive induction trajectories: bup1-started and remained on law; bup2-started low, shifted slowly to moderate; bup4-started high, shifted to low; bup5-started and remained on moderate; and bup6-started moderate, shifted to high dose. Baseline characteristics, including Clinical Opioid Withdrawal Scale (COWS), were important predictors of retention. When controlled for the baseline characteristics, bup6 participants were three times less likely to drop out the first 7 days than bup1 participants. Opioid use and AEs were similar across trajectories. Participants on greater-than-or-equal-to 16mg BUP compared to those on less than 16mg at Day 28 were less likely to drop out and less likely to experience AEs during the first 28 days.

Conclusions: BUP induction dosing was guided by an objective measure of opioid withdrawal. Participants with higher baseline COWS whose BUP doses were raised more quickly were less likely to drop out in the first 7 days than those whose doses were raised more slowly. This study supports the use of an objective measure of opioid withdrawal (COWS) during BUP induction to improve retention early in treatment.

Related protocols: CTN-0027

Abstract:

This study, supported in part by a CTN Invest Fellowship awarded to the first author, aimed to assess the prevalence of non-opioid drug use among opioid-addicted buprenorphine injecting individuals in Georgia (former Soviet republic), during and after a 12-week course of buprenorphine-naloxone (Suboxone) or methadone. This randomized, controlled trial used daily observed Suboxone or methadone and weekly counseling, urine tests, and Timeline Followback (TLFB) in weeks 0-12, and 20, as well as the Addiction Severity Index (ASI) at weeks 0, 4, 8, 12, and 20. Of the 80 patients (40/group, 4 women), 68 (85%) completed the 12 weeks of study treatment and 66 (82.5%) completed the 20 week follow-up.

At baseline, injecting more than one drug in the last 30 days was reported by 68.4% of patients in the methadone and 72.5% in the Suboxone groups. Drug use was markedly reduced in both treatment conditions, but there were significant differences in the prevalence of specific drugs with more opioid (1.5 vs. 0.2%; p = 0.03), less amphetamine (0.2 vs. 2.8%; p < 0.001) and less marijuana (1.7 vs. 10.2%; p < 0.001) positive urine tests in the methadone vs. Suboxone groups. At the 20 week follow-up, TLFB results on the 34 that continued methadone or the 3 on Suboxone showed less opioid (5.6 vs. 27.6%; p < 0.001), illicit buprenorphine (2.7 vs. 13.8%; p = 0.005), benzodiazepine (13.5 vs. 34.5%; p < 0.001), and marijuana (2.8 vs. 20.7%; p < 0.001) use than the 29 who did not continue opioid substitution therapy.

Conclusions: Daily observed methadone or buprenorphine-naloxone therapy with weekly counseling was markedly effective in reducing not only opioid use, but use of other psychoactive substances in Georgia, though there was more non-opioid use in patients treated with Suboxone, and more opioid use in patients treated with methadone. As in other settings, stopping opioid substitution therapy was associated with relapse to non-prescribed and other drug use.

Abstract:

Since first being identified in 1989, HCV has quickly gained attention as a public health concern due to its intense proliferation and negative consequences associated with chronic infection. In comparison with other blood-borne illnesses, HCV is now far more common than HIV/AIDS; and unlike HBV, HCV lacks available vaccines. Because injection drug use is by far the most significant risk factor for contracting HCV, and continued substance use among infected persons raises the risk for developing complications, as well as spreading the infection, this study sought to better understand the risk factors associated with HCV among patients enrolled into medication-assisted therapy for opioid dependence. Patients (N=1039) were randomized as part of a larger, multisite clinical trial sponsored by the National Drug Abuse Treatment Clinical Trials Network (CTN-0027) assessing liver function in opioid-dependent participants randomized to medication condition (buprenorphine/naloxone or methadone). HCV status was first assessed with an antibody screen; if positive, then current infection was determined with an antigen screen testing for detectable virus. Patients were classified as HCV negative, HCV positive but have cleared the virus, or as having chronic HCV. Logistic regression analysis was used to examine demographic and behavioral correlates of the three groups.

Thirty-four percent of patients were classified with chronic infection and 14% had evidence of prior infection with apparent clearing of the virus. Chronic infection was associated with recent injection drug use and cocaine use. Chronic HCV infection was also associated with being older and Hispanic.

Conclusions: Age, ethnicity, and current drug use increase the likelihood of being chronically infected with HCV. Strategies targeting high risk subgroups can aid in preventing further disease escalation. Further research would benefit from better understanding the role of ethnicity in transmission and/or spontaneous remission. Early intervention and continuous monitoring of IDUs should be the primary focus for addressing this epidemic.

Related protocols: CTN-0027

Abstract:

This is the Results Article for CTN-0030-A-3.

Despite 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 National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study (POATS, CTN-0030). POATS 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.

Results found that at 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. 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.

Conclusions: This was the first study to examine long-term treatment outcomes of patients with prescription opioid dependence, and results were more encouraging than short-term outcomes from POATS suggested they might be. Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. These results are consistent with research on heroin dependence in supporting the value of opioid agonist therapy for prescription opioid dependence; however, half of the follow-up participants reported good outcomes without agonist therapy as well. Additionally, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use. These data underscore the importance of longer-term follow-up in understanding the course of this increasingly prevalent substance use disorder.

Related protocols: CTN-0030, CTN-0030-A-3

Abstract:

Although research has generally supported the validity of substance use self-reports, some patients deny urine-verified substance use. This study examined the prevalence and patterns of denying urinalysis-confirmed opioid use in a sample of prescription opioid dependent patients. It also identified characteristics associated with denial in this population of increasing public health concern. Opioid use self-reports were compared with weekly urinalysis results in the National Drug Abuse Treatment Clinical Trials Network’s 12-week multi-site treatment study for prescription opioid dependence (CTN-0030 Prescription Opioid Addiction Treatment Study (POATS)). Among those who used opioids during the trial (n=246/360), 44.3% (n=109) denied urinalysis-confirmed opioid use, although usually only once (78%). Overall, 22.9% of opioid-positive urine tests (149/650) were denied on self-report. Multivariable analysis found that initially using opioids to relieve pain was associated with denying opioid use.

Conclusions: The present study shows that, although the clear majority of self-reports were consistent with urine results, many participants denied urine-confirmed use, albeit infrequently, despite knowing they would be tested. This result, combined with the finding that 7% of the positive self-reports were provided in a week with a negative urine test, shows the importance of obtaining both self-report data and urine tests; neither one alone is adequate.

Related protocols: CTN-0030