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Corrigendum to "Naturalistic follow-up after a trial of medications for opioid use disorder: Medication status, opioid use, and relapse" [Journal of Substance Abuse Treatment 131 (2021) 108447]

Greiner, Miranda G; Shulman, Matisyahu; Choo, Tse-Hwei; Scodes, Jennifer; Pavlicova, Martina; Campbell, Aimee N C; Novo, Patricia; Fishman, Marc; Lee, Joshua D; Rotrosen, John; Nunes, Edward V
PMID: 34366203
ISSN: 1873-6483
CID: 5006082

Use of non-prescribed buprenorphine in the criminal justice system: Perspectives of individuals recently released from incarceration

Gryczynski, Jan; Lee, Joshua D; Dusek, Kristi; McDonald, Ryan; Sharma, Anjalee; Malone, Mia; Monico, Laura B; Cheng, Anna; DeVeaugh-Geiss, Angela; Chilcoat, Howard D
Buprenorphine, an effective treatment for opioid use disorder (OUD), remains underutilized in many U.S. jails and prisons. However, use of non-prescribed (i.e., diverted) buprenorphine has been reported in these settings. The current study examined non-prescribed buprenorphine use experiences in correctional and community contexts. The study conducted face-to-face interviews with 300 adults with OUD/opioid misuse and recent incarceration, recruited in Baltimore, MD, and New York, NY (n = 150 each). Illicit/non-prescribed opioid use during incarceration was reported by 63% of participants; 39% reported non-prescribed buprenorphine. Non-prescribed buprenorphine was considered the most widely available opioid in jails/prisons in both states (81% reported "very" or "somewhat" easy to get). The average price of non-prescribed buprenorphine in jail/prison was ~10× higher than in the community (p < 0.001). Participants were more likely to endorse getting high/mood alteration as reasons for using non-prescribed buprenorphine during incarceration, but tended to ascribe therapeutic motives to use in the community (e.g., self-treatment; p < 0.001). Multivariable logistic regression analyses showed that different individual-level characteristics were associated with history of non-prescribed buprenorphine use during incarceration and in the community. Use of non-prescribed buprenorphine during incarceration was associated with younger age (p = 0.006) and longer incarceration history (p < 0.001), while use of non-prescribed buprenorphine in the community was associated with MD recruitment site (p = 0.001), not being married (p < 0.001), prior buprenorphine treatment experience (p < 0.001), and housing situation (p = 0.01). These findings suggest that different dynamics and demand characteristics underlie the use of non-prescribed buprenorphine in community and incarceration contexts, with implications for efforts to expand OUD treatment in correctional settings.
PMID: 34134866
ISSN: 1873-6483
CID: 4936792

Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment

Nunes, Edward V; Scodes, Jennifer M; Pavlicova, Martina; Lee, Joshua D; Novo, Patricia; Campbell, Aimee N C; Rotrosen, John
OBJECTIVE:Sublingual buprenorphine-naloxone and extended-release injection naltrexone are effective treatments, with distinct mechanisms, for opioid use disorder. The authors examined whether patients' demographic and clinical characteristics were associated with better response to one medication or the other. METHODS:In a multisite 24-week randomized comparative-effectiveness trial of assignment to buprenorphine-naloxone (N=287) compared with extended-release naltrexone (N=283) comprising inpatients planning to initiate medication treatment for opioid use disorder, 50 demographic and clinical characteristics were examined as moderators of the effect of medication assignment on relapse to regular opioid use and failure to initiate medication. Moderator-by-medication interactions were estimated using logistic regression with correction for multiple testing. RESULTS:In the intent-to-treat sample, patients who reported being homeless had a lower relapse rate if they were assigned to receive extended-release naltrexone (51.6%) compared with buprenorphine-naloxone (70.4%) (odds ratio=0.45, 95% CI=0.22, 0.90); patients who were not homeless had a higher relapse rate if they were assigned to extended-release naltrexone (70.9%) compared with buprenorphine-naloxone (53.1%) (odds ratio=2.15, 95% CI=1.44, 3.21). In the subsample of patients who initiated medication, the interaction was not significant, with a similar pattern of lower relapse with extended-release naltrexone (41.4%) compared with buprenorphine (68.6%) among homeless patients (odds ratio=0.32, 95% CI=0.15, 0.68) but less difference among those not homeless (extended-release naltrexone, 57.2%; buprenorphine, 52.0%; odds ratio=1.24, 95% CI=0.80, 1.90). For failure to initiate medication, moderators were stated preference for medication (failure was less likely if the patient was assigned to the medication preferred), parole and probation status (fewer failures with extended-release naltrexone for those on parole or probation), and presence of pain and timing of randomization (more failure with extended-release naltrexone for patients endorsing moderate to severe pain and randomized early while still undergoing medically managed withdrawal). CONCLUSIONS:Among patients with opioid use disorder admitted to inpatient treatment, homelessness, parole and probation status, medication preference, and factors likely to influence tolerability of medication initiation may be important in matching patients to buprenorphine or extended-release naltrexone.
PMID: 34170188
ISSN: 1535-7228
CID: 5116812

E-cigarette use and beliefs among adult smokers with substance use disorders

El-Shahawy, Omar; Schatz, Daniel; Sherman, Scott; Shelley, Donna; Lee, Joshua D; Tofighi, Babak
Background/UNASSIGNED:We explored characteristics and beliefs associated with e-cigarette use patterns among cigarette smokers requiring inpatient detoxification for opioid and/or alcohol use disorder(s). Methods/UNASSIGNED:-test statistics, and logistic regression models were used. Results/UNASSIGNED: Conclusions/UNASSIGNED:E-cigarette use seems to be appealing to a small proportion of cigarette smokers with SUD. Although, dual smokers seem to use e-cigarettes for its cessation premise, they don't appear to be actively seeking to quit. E-cigarettes may offer a more effective method for harm reduction, further evaluation of incorporating it within smoking cessation protocols among patients in addiction treatment is needed.
PMCID:7772361
PMID: 33385062
ISSN: 2352-8532
CID: 4731972

Correlates of opioid abstinence after randomization to buprenorphine-naloxone versus injectable naltrexone in a multi-site trial [Meeting Abstract]

Greiner, M; Campbell, A; Nunes, E; Pavlicova, M; Rotrosen, J; Shulman, M; Scodes, J; Lee, J D; Novo, P; Choo, T -H
This activity is a paper presentation on a secondary analysis of factors associated with opioid abstinence three months following the treatment trial. While abstinence is not required for improvement in opioid use outcomes, better understanding of abstinence-related factors can inform efforts to facilitate stable recovery for opioid-dependent individuals. XXBackground(s): Opioid use disorder (OUD) is associated with substantial mortality. There are effective treatments in reducing opioid use and overdose events. However, many patients that successfully initiate OUD pharmacotherapy will discontinue treatment within the first few weeks or months. Upon treatment discontinuation, patients are at risk for relapse and overdose, however, not all patients relapse. There is a need to better understand predictors of relapse and abstinence after medication discontinuation. XXObjective(s): 1) Demonstrate general understanding of effective treatments for OUD and current barriers to treatment retention. 2) Describe factors associated with opioid abstinence from this secondary analysis. 3) Identify limitations in analyses and interpreting results. XXMethod(s): This secondary analysis examines correlates of opioid abstinence in 428 participants at week 36 follow-up from the National Drug Abuse Treatment Clinical Trials Network CTN-0051) X:BOT trial. X:BOT randomized participants to buprenorphine-naloxone (BUP-NX) or extended-release injectable naltrexone (XR-NTX) for up to 24 weeks of outpatient treatment. Study medications were discontinued at study completion or relapse. Follow-up assessments in the community were done at weeks 28 and 36. XXResult(s): Participants had higher odds of being abstinent at week 36 if randomized to XR-NTX compared with BUP-NX (odds ratio [OR] [95% confidence interval [CI]] = 2.47 [1.63, 3.74]), were on XR-NTX at follow-up compared with those off medication (OR = 2.33 [1.40, 3.90]), had longer time to relapse (OR = 1.04 [1.02, 1.07]), successfully inducted onto study medication compared with those who failed induction (OR = 3.16 [1.45, 6.92]), had longer time on study medication (OR = 1.03[1.01, 1.05]), and had more abstinent weeks during the trial (OR = 1.04 [1.02, 1.07]). XXConclusion(s): In general, participants that had better outcomes during the treatment trial were found to be abstinent from opioids at follow-up in the community. This included successful induction onto study medication, longer time on medication, greater time to relapse, and more abstinent weeks. While abstinence is not required for improvement in opioid use outcomes, better understanding of abstinence-related factors can inform efforts to facilitate stable recovery for opioid-dependent individuals. Scientific Significance: There is a need to better understand predictors of relapse and abstinence after medication discontinuation in order to better advise patients that may discontinue medications. Barriers to treatment retention and sustained abstinence are factors generally considered to be proxies for greater disease severity. Less is understood about factors associated with sustained abstinence
EMBASE:635344096
ISSN: 1521-0391
CID: 4928772

Association between methadone or buprenorphine use during medically supervised opioid withdrawal and extended-release injectable naltrexone induction failure

Shulman, Matisyahu; Choo, Tse-Hwei; Scodes, Jennifer; Pavlicova, Martina; Wai, Jonathan; Haenlein, Patrick; Tofighi, Babak; Campbell, Aimee N C; Lee, Joshua D; Rotrosen, John; Nunes, Edward V
BACKGROUND:Extended-release naltrexone (XR-NTX) is an effective maintenance treatment for opioid use disorder, but induction from active opioid use is a challenge as individuals must complete detoxification before induction. We aimed to determine whether use of methadone or buprenorphine, long acting agonist opioids commonly used for detoxification, were associated with decreased likelihood of induction onto XR-NTX. METHODS:We performed a secondary analysis of a large open-label randomized trial of buprenorphine versus XR-NTX for treatment of individuals with opioid use disorder recruited from eight short term residential (detoxification) units. This analysis only included individuals randomized to the XR-NTX arm of the trial (N = 283). The method of detoxification varied according to usual practices at each inpatient program. Logistic regression models estimating the log-odds of induction onto XR-NTX were fit, with detoxification regimen received as the predictor. RESULTS:In the unadjusted logistic regression model, detoxification drug received (either methadone or buprenorphine) was significantly associated with decreased likelihood of induction onto XR-NTX compared to receiving non-opioid detoxification (Overall: P < 0.001); buprenorphine vs non-opioid detoxification: OR (95% CI) = 0.32 (0.15-0.67); methadone vs non-opioid detoxification: OR (95% CI) = 0.23 (0.11-0.46). After controlling for site as a random effect, the association of detoxification drug with induction success lost statistical significance. CONCLUSIONS:Use of agonist medication during detoxification was associated with XR-NTX induction failure. Medication choice was determined by each site's clinical practice and therefore this association could not be separated from other site level variables. CLINICAL TRIAL REGISTRATION/BACKGROUND:NCT02032433.
PMCID:8004552
PMID: 33771287
ISSN: 1873-6483
CID: 4830232

Naturalistic follow-up after a trial of medications for opioid use disorder: Medication status, opioid use, and relapse

Greiner, Miranda G; Shulman, Matisyahu; Choo, Tse-Hwei; Scodes, Jennifer; Pavlicova, Martina; Campbell, Aimee N C; Novo, Patricia; Fishman, Marc; Lee, Joshua D; Rotrosen, John; Nunes, Edward V
AIM/OBJECTIVE:This report examined naturalistic opioid use outcomes and utilization of medications for opioid use disorder (MOUD) 36 weeks post-randomization in the National Drug Abuse Treatment Clinical Trials Network (CTN) Extended-Release Naltrexone (XR-NTX) versus Buprenorphine-Naloxone (BUP-NX) for Opioid Treatment trial (CTN-0051, X:BOT). DESIGN/METHODS:X:BOT was a multisite, randomized, 24-week comparative effectiveness trial of BUP-NX (N = 287) and XR-NTX (N = 283). Study medications were discontinued following treatment completion, relapse, or dropout. Participants were encouraged to continue MOUD. This report examined opioid use outcomes in 428 (75%) of the 570 participants who attended the 36-week follow-up visit. SETTING AND PARTICIPANTS/METHODS:Adults with opioid use disorder recruited from 8 community treatment programs across the United States. MEASUREMENTS/METHODS:Outcomes included medication status (on/off MOUD), type of MOUD (BUP-NX, XR-NTX, or methadone), abstinence from non-prescribed opioids, opioid use days, relapse, and other substance use 30 days prior to the 36-week visit. Relapse was defined as opioid use for 4 consecutive weeks or 7 consecutive days in the past month. Baseline and clinical variables included opioid use severity, intravenous drug use, study medication assignment, and induction status. FINDINGS/RESULTS:Of the 428 participants who completed the 36-week visit, 225 (53%) of participants were receiving MOUD and 203 (47%) were not. Compared to those off medication, participants on medication had fewer opioid use days (4.4 days (SD 9.0) versus 9.8 days (SD 12.1)), fewer met relapse criteria (37 (16.4%) versus 79 (38.9%)), and reported less stimulant use (34 (15.2%) versus 56 (27.7%)) and sedative use (14 (6.3%) versus 31 (15.3%)). There was no difference in abstinence rates between those on or off MOUD. A greater proportion of participants on XR-NTX (47 (53.4%) of 88 participants) were abstinent from non-prescribed opioids compared to those on buprenorphine (28 (23.3%) of 120 participants). CONCLUSIONS:Naturalistic outcomes data showed that despite potential barriers to continuing treatment in the community, about half of individuals were on opioid use disorder pharmacotherapy at follow-up and those on medication generally had better outcomes. Future research should explore barriers and facilitators to treatment retention in community settings; and developing interventions tailored to improve treatment engagement and adherence.
PMID: 34098301
ISSN: 1873-6483
CID: 4898252

Exploring nonprescribed use of buprenorphine in the criminal justice system through qualitative interviews among individuals recently released from incarceration

Monico, Laura B; Gryczynski, Jan; Lee, Joshua D; Dusek, Kristi; McDonald, Ryan; Malone, Mia; Sharma, Anjalee; Cheng, Anna; DeVeaugh-Geiss, Angela; Chilcoat, Howard
BACKGROUND:Buprenorphine treatment remains unavailable in many jails and prisons, but use of nonprescribed (i.e., diverted) buprenorphine has been reported in these settings. The purpose of this analysis is to explore the experiences and motivations behind the use of diverted buprenorphine among recently incarcerated individuals. METHODS:Adults with opioid misuse who were recently released from jail or prison (n= 26; 58% male) completed semi-structured qualitative interviews as part of a study focused on buprenorphine diversion in the criminal justice system. Qualitative interviews explored participants' incarceration experiences and opioid use background, knowledge of buprenorphine and other substance use in jails/prisons, personal use of buprenorphine while incarcerated, reasons for using buprenorphine while incarcerated, and knowledge of how buprenorphine is brought into and acquired in jails/prisons. The study recorded and transcribed interviews, and analyzed the narratives for content related to these predetermined thematic areas. RESULTS:Key themes emerging from the interviews surrounding buprenorphine diversion during incarceration included: 1) the perceived high prevalence of diverted buprenorphine in jail/prison settings, 2) how the perception of prevalence is related to buprenorphine sublingual film formulation, 3) adaptive routes of administration related to the high cost of diverted buprenorphine, and 4) reasons individuals who are incarcerated use diverted buprenorphine (to achieve euphoric effects and cope with confinement, in contrast to using for self-treatment/withdrawal management as is done in the community). CONCLUSION/CONCLUSIONS:Participants reported widespread availability of diverted buprenorphine in criminal justice facilities, and characterized reasons for its use specific to these contexts. More research is needed to determine the impact of expanding buprenorphine treatment in jails and prisons on inmates' use of diverted buprenorphine, and future research should explore these intersections as treatment initiation opportunities.
PMID: 33612198
ISSN: 1873-6483
CID: 4799952

Young Adults Have Worse Outcomes Than Older Adults: Secondary Analysis of a Medication Trial for Opioid Use Disorder

Fishman, Marc; Wenzel, Kevin; Scodes, Jennifer; Pavlicova, Martina; Lee, Joshua D; Rotrosen, John; Nunes, Edward
PURPOSE/OBJECTIVE:Young adults are disproportionately affected by the current opioid crisis. Although medications for opioid use disorder are broadly effective, with reductions in morbidity and mortality, the particular effectiveness of medications for opioid use disorder among young adults is less well understood. METHODS:This secondary analysis compared young adults (aged 18-25 years) with older adults (aged ≥26 years) in a large comparative effectiveness trial ("XBOT") that randomized subjects to extended-release naltrexone or sublingual buprenorphine-naloxone for 6 months. Opioid relapse was defined by opioid use over four consecutive weeks or seven consecutive days, using urine testing and self-report. RESULTS:Among subjects in the intention-to-treat sample (n = 570, all randomized participants), a main effect of age group was found, with higher relapse rates among young adults (70.3%) compared with older adults (58.2%), with an odds ratio of 1.72 (95% confidence interval = 1.08-2.70), p = .02. In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06). Among the intention-to-treat sample, survival analysis revealed a significant time-by-age group interaction (p = .01) with more relapse over time in young adults. No significant interactions between age and medication group were detected. CONCLUSIONS:Young adults have increased rates of relapse compared with older adults, perhaps because of vulnerabilities that increase their risk for treatment dropout and medication nonadherence, regardless of medication assignment. These results suggest that specialized, developmentally informed interventions may be needed to improve retention and successful treatment of opioid use disorder among young adults.
PMID: 32873500
ISSN: 1879-1972
CID: 4615352

Variants of opioid genes and response to treatment of opioid use disorder with buprenorphine-naloxone versus extended-release naltrexone in Caucasians

Randesi, Matthew; Rotrosen, John; Nunes, Edward V; Lee, Joshua D; Novo, Patricia; Levran, Orna; Ott, Jurg; Pavlicova, Martina; Scodes, Jennifer; Kreek, Mary Jeanne
BACKGROUND:Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD), combines buprenorphine (a partial mu/kappa agonist) with naloxone (a mu/ kappa antagonist). Extended-release injection naltrexone (XR-NTX; a mu receptor antagonist and kappa receptor partial agonist) is also an FDA-approved treatment for OUD. However, while some patients respond well to these medications, many others leave treatment and relapse. OBJECTIVES/OBJECTIVE:Determine whether gene variants in the opioid gene system are associated with better or worse treatment response. METHODS:= 334), two outcomes measures were assessed: received first dose (yes/no) and received last dose (yes/no). Separate logistic regressions were used to each model outcome measure as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction. RESULTS:There were no significant main effects of gene variant on receiving first dose or last dose. There were also no significant gene variant by treatment interactions. CONCLUSIONS:The outcome of treatment of OUD with medications is likely a complex function of multiple factors, including environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.
PMID: 32851876
ISSN: 1097-9891
CID: 4576272