Literature Collection

OBJECTIVE: The purpose of this study was to investigate if brief treatment for alcohol dependence in primary care with the 15-method was as effective as specialist addiction care. In addition, we sought to investigate trajectories for change of alcohol consumption. METHOD: This study was a randomized controlled noninferiority trial, between-groups parallel design, with a noninferiority limit of 50 g of alcohol per week. A total of 288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic. The primary outcome was change in weekly alcohol consumption at the 12-month follow-up. Secondary outcomes were heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers. Trajectories were investigated using change in World Health Organization drinking risk levels. RESULTS: The intention-to-treat analysis (n = 231) showed that the estimated weekly alcohol consumption in primary care was 18.2 g (95% CI [14.9, 51.3]) higher compared with specialist care (p = .28). Noninferiority was not demonstrated as the confidence interval exceeded the noninferiority limit. The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment. The analyses of trajectories showed the main part of change in consumption occurred from baseline to the 6-month follow-up and was maintained to the 12-month follow-up. CONCLUSIONS: Although noninferiority could not be demonstrated, based on similar trajectories and sustained reduction of alcohol use, this study indicates brief treatment of alcohol dependence in primary care with the 15-method is a feasible and promising approach.

IMPORTANCE: There are high rates of maternal and newborn morbidity and mortality associated with opioid use disorder (OUD). Integrating OUD treatment in obstetric practices for pregnant and postpartum women via telemedicine can increase access to care and reduce the consequences of OUD. Evaluation of this care delivery model, however, is needed before widespread adoption. OBJECTIVE: To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine vs in person. DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized controlled trial including 98 women receiving perinatal OUD treatment in 4 outpatient obstetric practices by telemedicine or in person and followed up until 6 to 8 weeks post partum was conducted from September 4, 2017, to December 31, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables. INTERVENTIONS: Participants were seen weekly for 4 weeks, every 2 weeks for 4 weeks, and monthly thereafter and provided relapse prevention therapy and buprenorphine. MAIN OUTCOMES AND MEASURES: The outcomes were retention in treatment, defined as uninterrupted addiction treatment during pregnancy through 6 to 8 weeks post partum; urine drug screen results at delivery and 6 to 8 weeks post partum; and a neonatal abstinence syndrome (NAS) diagnosis collected via electronic health records. RESULTS: The mean (SD) age of the 98 pregnant women was 30.23 (5.12) years. Of these, 41 of 44 women (93.2%) in the telemedicine group and 48 of 54 women (88.9%) in the in-person group chose to continue treatment in the program after an initial evaluation. After propensity score weighting and doubly robust estimation, no significant differences were found between groups in retention in treatment at 6 to 8 weeks post partum (telemedicine: 80.4% vs in person: 92.7%; treatment effect, -12.2%; 95% CI, -32.3% to -4.4%). Similarly, after propensity score weighting and doubly robust estimation, there were no significant group differences in rates of NAS (telemedicine: 45.4% vs in person: 63.2%; treatment effect, -17.8%; 95% CI, -41.0% to 8.9%). CONCLUSIONS AND RELEVANCE: In this nonrandomized controlled trial, virtually integrated OUD care in obstetric practices produced similar maternal and newborn outcomes compared with in-person care. These findings may have important public health implications for combatting the opioid crisis and its consequences on pregnant women and their families. Future large randomized clinical trials are needed. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04049032.

Opioid use disorder (OUD) is a common, treatable chronic disease that can be effectively managed in primary care settings. Untreated OUD is associated with considerable morbidity and mortality-notably, overdose, infectious complications of injecting drug use, and profoundly diminished quality of life. Withdrawal management and medication tapers are ineffective and are associated with increased rates of relapse and death. Pharmacotherapy is the evidence based mainstay of OUD treatment, and many studies support its integration into primary care settings. Evidence is strongest for the opioid agonists buprenorphine and methadone, which randomized controlled trials have shown to decrease illicit opioid use and mortality. Discontinuation of opioid agonist therapy is associated with increased rates of relapse and mortality. Less evidence is available for the opioid antagonist extended release naltrexone, with a meta-analysis of randomized controlled trials showing decreased illicit opioid use but no effect on mortality. Treating OUD in primary care settings is cost effective, improves outcomes for both OUD and other medical comorbidities, and is highly acceptable to patients. Evidence on whether behavioral interventions improve outcomes for patients receiving pharmacotherapy is mixed, with guidelines promoting voluntary engagement in psychosocial supports, including counseling. Further work is needed to promote the integration of OUD treatment into primary care and to overcome regulatory barriers to integrating methadone into primary care treatment in the US.

BACKGROUND: Ibogaine is a monoterpene indole alkaloid used in medical and nonmedical settings for the treatment of opioid use disorder. Its mechanism of action is apparently novel. There are no published prospective studies of drug use outcomes with ibogaine. OBJECTIVES: To study outcomes following opioid detoxification with ibogaine. METHODS: In this observational study, 30 subjects with DSM-IV Opioid Dependence (25 males, 5 females) received a mean total dose of 1,540 +/- 920 mg ibogaine HCl. Subjects used oxycodone (n = 21; 70%) and/or heroin (n = 18; 60%) in respective amounts of 250 +/- 180 mg/day and 1.3 +/- 0.94 g/day, and averaged 3.1 +/- 2.6 previous episodes of treatment for opioid dependence. Detoxification and follow-up outcomes at 1, 3, 6, 9, and 12 months were evaluated utilizing the Subjective Opioid Withdrawal Scale (SOWS) and Addiction Severity Index Composite (ASIC) scores, respectively. RESULTS: SOWS scores decreased from 31.0 +/- 11.6 pretreatment to 14.0 +/- 9.8 at 76.5 +/- 30 hours posttreatment (t = 7.07, df = 26, p < 0.001). At 1-month posttreatment follow-up, 15 subjects (50%) reported no opioid use during the previous 30 days. ASIC Drug Use and Legal and Family/Social Status scores were improved relative to pretreatment baseline at all posttreatment time points (p < .001). Improvement in Drug Use scores was maximal at 1 month, and subsequently sustained from 3 to 12 months at levels that did not reach equivalence to the effect at 1 month. CONCLUSION: Ibogaine was associated with substantive effects on opioid withdrawal symptoms and drug use in subjects for whom other treatments had been unsuccessful, and may provide a useful prototype for discovery and development of innovative pharmacotherapy of addiction.