Faculty Bibliography

BACKGROUND: The acceptability, feasibility and effectiveness of web-based interventions among criminal justice involved populations are understudied. This study is a secondary analysis of baseline characteristics associated with criminal justice system (CJS) status as treatment outcome moderators among participants enrolling in a large randomized trial of a web-based psychosocial intervention (Therapeutic Education System [TES]) as part of outpatient addiction treatment. METHODS: We compared demographic and clinical characteristics, TES participation rates, and the trial's two co-primary outcomes, end of treatment abstinence and treatment retention, by self-reported CJS status at baseline: 1) CJS-mandated to community treatment (CJS-mandated), 2) CJS-recommended to treatment (CJS-recommended), 3) no CJS treatment mandate (CJS-none). RESULTS: CJS-mandated (n = 107) and CJS-recommended (n = 69) participants differed from CJS-none (n = 331) at baseline: CJS-mandated were significantly more likely to be male, uninsured, report cannabis as the primary drug problem, report fewer days of drug use at baseline, screen negative for depression, and score lower for psychological distress and higher on physical health status; CJS-recommended were younger, more likely single, less likely to report no regular Internet use, and to report cannabis as the primary drug problem. Both CJS-involved (CJS -recommended and -mandated) groups were more likely to have been recently incarcerated. Among participants randomized to the TES arm, module completion was similar across the CJS subgroups. A three-way interaction of treatment, baseline abstinence and CJS status showed no associations with the study's primary abstinence outcome. CONCLUSIONS: Overall, CJS-involved participants in this study tended to be young, male, and in treatment for a primary cannabis problem. The feasibility and effectiveness of the web-based psychosocial intervention, TES, did not vary by CJS-mandated or CJS-recommended participants compared to CJS-none. Web-based counseling interventions may be effective interventions as US public safety policies begin to emphasize supervised community drug treatment over incarceration.

The prevalence of urine tampering within office-based opioid treatment (OBOT) is not currently known. This study was a cross-sectional analysis of an OBOT practice in New York City that experienced both a change in provider and a change in electronic medical record software. At that time, every patient in the practice received a urine drug test for "quantitative buprenorphine metabolites." METHODS: Outcomes of the first three urine drug tests were tabulated and analyzed with specific attention to the frequency of buprenorphine-positive (bup+), norbuprenorphine-negative (norbup-) samples, a pattern consistent with urine tampering. RESULTS: On the first sample 6/33 (18%) of patients submitted bup+/norbup- samples, and an additional 3 patients submitted bup+/norbup- samples on subsequent urine tests. Retention to the end of the study period among patients with bup+/norbup- samples was 33%, while in those with bup+/norbup+samples it was 96%. A scatter plot of norbuprenorphine vs. buprenorphine levels estimated that a ratio of <0.2 indicated tampering. CONCLUSION: Testing for buprenorphine metabolites yields valuable clinical information. The prevalence of a result pattern consistent with tampering by "urine spiking," the addition of unconsumed buprenorphine into the urine sample, may be higher than previous estimates. Previous lower cutoffs of the norbuprenorphine:buprenorphine metabolic ratio may miss a substantial proportion of these likely tampered samples.

Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit.

BACKGROUND AND AIMS: Criminal justice-involved individuals are highly susceptible to opioid relapse and overdose-related deaths. In a recent randomized trial, we demonstrated the effectiveness of extended-release naltrexone (XR-NTX; Vivitrol(R) ) in preventing opioid relapse among criminal justice-involved US adults with a history of opioid use disorder. The cost of XR-NTX may be a significant barrier to adoption. Thus, it is important to account for improved quality of life and downstream cost-offsets. Our aims were to (1) estimate the incremental cost per quality-adjusted life-year (QALY) gained for XR-NTX versus treatment as usual (TAU) and evaluate it relative to generally accepted value thresholds; and (2) estimate the incremental cost per additional year of opioid abstinence. DESIGN: Economic evaluation of the aforementioned trial from the taxpayer perspective. Participants were randomized to 25 weeks of XR-NTX injections or TAU; follow-up occurred at 52 and 78 weeks. SETTING: Five study sites in the US Northeast corridor. PARTICIPANTS: A total of 308 participants were randomized to XR-NTX (n = 153) or TAU (n = 155). MEASUREMENTS: Incremental costs relative to incremental economic and clinical effectiveness measures, QALYs and abstinent years, respectively. FINDINGS: The 25-week cost per QALY and abstinent-year figures were $162 150 and $46 329, respectively. The 78-week figures were $76 400/QALY and $16 371/abstinent year. At 25 weeks, we can be 10% certain that XR-NTX is cost-effective at a value threshold of $100 000/QALY and 62% certain at $200 000/QALY. At 78 weeks, the cost-effectiveness probabilities are 59% at $100 000/QALY and 76% at $200 000/QALY. We can be 95% confident that the intervention would be considered 'good value' at $90 000/abstinent year at 25 weeks and $500/abstinent year at 78 weeks. CONCLUSIONS: While extended-release naltrexone appears to be effective in increasing both quality-adjusted life-years (QALYs) and abstinence, it does not appear to be cost-effective using generally accepted value thresholds for QALYs, due to the high price of the injection.

ISSUES: Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. APPROACH: Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. KEY FINDINGS: Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. IMPLICATIONS: Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. CONCLUSION: Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;00:000-000].

Buprenorphine office-based opioid maintenance is an increasingly common form of treatment for opioid use disorders. However, total prescribing has not kept pace with the current opioid and overdose epidemic and access remains scarce among the underserved. This study sought to assess current provider attitudes and clinical practices among a targeted sample of primarily New York City public sector buprenorphine prescribers. A cross-sectional online survey purposefully sampled buprenorphine prescribers in NYC with a focus on those serving Medicaid and uninsured patient populations. Expert review of local provider networks, snowball referrals, and in-person networking generated an email list, which received a survey link. A brief 25-question instrument queried provider and practice demographics, prescribing practices including induction approaches and attitudes regarding common hot topics (e.g., buprenorphine diversion, prescriber patient limits, insurance issues, ancillary treatments). Of 132 email invitations, N=72 respondents completed (n=64) or partially completed (n=8) the survey between January and April 2016. Most (79%) were Medicaid providers in non-psychiatric specialties (72%), working in a hospital-based or community general practice (51%), and board-certified in addiction medicine or psychiatry (58%). Practice sizes were generally 100 patients or fewer (71%); many providers (64%) individually prescribed buprenorphine <25% of total practice time to a median 23 patients (mean 31, range 0-102). Unobserved (home) induction for new patients was a common practice: 49% predominantly prescribed unobserved induction; 16% mixed unobserved and observed inductions. Adjunctive psychosocial counseling was routinely recommended (46%) or considered on a case-by-case basis (17%) versus mandated (37%). Medication prior authorization requirements were the highest rated barriers to practice, followed by inadequate clinic space, limited clinic time and/or support staff, and inadequate psychiatric services for dual diagnoses. Buprenorphine diversion was not rated as an important practice barrier. In conclusion, this targeted survey of buprenorphine prescribers in NYC treating primarily underserved populations showed a consistent pattern of part-time prescribing to modest volumes of patients, routine use of unobserved buprenorphine induction, and primarily elective referrals to psychosocial counseling. Barriers to prescribing included prior authorization requirements, lack of clinical resources (space, staff) and psychiatric services. Federal and local efforts to reduce such barriers may improve buprenorphine access among the underserved.

BACKGROUND: Buprenorphine maintenance for opioid dependence remains of limited availability among underserved populations, despite increases in US opioid misuse and overdose deaths. Low threshold primary care treatment models including the use of unobserved, "home," buprenorphine induction may simplify initiation of care and improve access. Unobserved induction and long-term treatment outcomes have not been reported recently among large, naturalistic cohorts treated in low threshold safety net primary care settings. METHODS: This prospective clinical registry cohort design estimated rates of induction-related adverse events, treatment retention, and urine opioid results for opioid dependent adults offered buprenorphine maintenance in a New York City public hospital primary care office-based practice from 2006 to 2013. This clinic relied on typical ambulatory care individual provider-patient visits, prescribed unobserved induction exclusively, saw patients no more than weekly, and did not require additional psychosocial treatment. Unobserved induction consisted of an in-person screening and diagnostic visit followed by a 1-week buprenorphine written prescription, with pamphlet, and telephone support. Primary outcomes analyzed were rates of induction-related adverse events (AE), week 1 drop-out, and long-term treatment retention. Factors associated with treatment retention were examined using a Cox proportional hazard model among inductions and all patients. Secondary outcomes included overall clinic retention, buprenorphine dosages, and urine sample results. RESULTS: Of the 485 total patients in our registry, 306 were inducted, and 179 were transfers already on buprenorphine. Post-induction (n = 306), week 1 drop-out was 17%. Rates of any induction-related AE were 12%; serious adverse events, 0%; precipitated withdrawal, 3%; prolonged withdrawal, 4%. Treatment retention was a median 38 weeks (range 0-320) for inductions, compared to 110 (0-354) weeks for transfers and 57 for the entire clinic population. Older age, later years of first clinic visit (vs. 2006-2007), and baseline heroin abstinence were associated with increased treatment retention overall. CONCLUSIONS: Unobserved "home" buprenorphine induction in a public sector primary care setting appeared a feasible and safe clinical practice. Post-induction treatment retention of a median 38 weeks was in line with previous naturalistic studies of real-world office-based opioid treatment. Low threshold treatment protocols, as compared to national guidelines, may compliment recently increased prescriber patient limits and expand access to buprenorphine among public sector opioid use disorder patients.

We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed. We examine how the design features underlying these ethical issues are characteristic of effectiveness trials, which are often large trials that compare treatments with varying degrees of existing effectiveness data and familiarity to patients and clinicians, in community-based treatment settings, with minimal exclusion criteria that could involve vulnerable populations. Hence, investigators designing effectiveness trials may wish to remain alert to the possibility of similar ethical issues.