Literature Collection

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.

AIMS: Stimulant use disorder contributes to a substantial worldwide burden of disease, although evidence-based treatment options are limited. This systematic review of reviews aims to: (i) synthesize the available evidence on both psychosocial and pharmacological interventions for the treatment of stimulant use disorder; (ii) identify the most effective therapies to guide clinical practice, and (iii) highlight gaps for future study. METHODS: A systematic database search was conducted to identify systematic reviews and meta-analyses. Eligible studies were those that followed standard systematic review methodology and assessed randomized controlled trials focused on the efficacy of interventions for stimulant use disorder. Articles were critically appraised using an assessment tool adapted from Palmeteer et al. and categorized for quality as 'core' or 'supplementary' reviews. Evidence from the included reviews were further synthesized according to pharmacological or non-pharmacological management themes. RESULTS: Of 476 identified records, 29 systematic reviews examining eleven intervention modalities were included. The interventions identified include: contingency management, cognitive behavioural therapy, acupuncture, antidepressants, dopamine agonists, antipsychotics, anticonvulsants, disulfiram, opioid agonists, N-Acetylcysteine, and psychostimulants. There was sufficient evidence to support the efficacy of contingency management programs for treatment of stimulant use disorder. Psychostimulants, n-acetylcysteine, opioid agonist therapy, disulfiram and antidepressant pharmacological interventions were found to have insufficient evidence to support or discount their use. Results of this review do not support the use of all other treatment options. CONCLUSIONS: The results of this review supports the use of contingency management interventions for the treatment of stimulant use disorder. Although evidence to date is insufficient to support the clinical use of psychostimulants, our results demonstrate potential for future research in this area. Given the urgent need for effective pharmacological treatments for stimulant use disorder, high-quality primary research focused on the role of psychostimulant medications for the treatment of stimulant use disorder is needed.

BACKGROUND: COVID-19 worsened an already existing problem in substance use disorder (SUD) treatment. However, it helped transform the use of telehealth, which particularly benefits rural America. The lack of specialty addiction treatment in rural areas places the onus on primary care providers. Screening, brief intervention, and referral to treatment (SBIRT) is an evidenced-based strategy commonly used in primary care settings to target SUD outcomes and related behaviors. The integration of telehealth tools within the SBIRT pathway may better sustain the program in primary care. Building on Mayo Clinic's experience with collaborative care management (CoCM) for mental health treatment, we built a digitally native, integrated, behavioral health CoCM platform using a novel mobile app and web-based provider platform called Senyo Health. OBJECTIVE: This protocol describes a novel use of the SBIRT pathway using Senyo Health to complement existing CoCM integration within primary care to deliver SUD treatment to rural patients lacking other access. We hypothesize that this approach will improve SUD-related outcomes within rural primary care clinics. METHODS: Senyo Health is a digital tool to facilitate the use of SBIRT in primary care. It contains a web-based platform for clinician and staff use and a patient-facing mobile phone app. The app includes 16 learning modules along with data collection tools and a chat function for communicating directly with a licensed drug counselor. Beta-testing is currently underway to examine opportunities to improve Senyo Health prior to the start of the trial. We describe the development of Senyo Health and its therapeutic content and data collection instruments. We also describe our evaluation strategy including our measurement plan to assess implementation through a process guided by Consolidated Framework for Implementation Research methods and effectiveness through a waitlist control trial. A randomized controlled trial will occur where 30 participants are randomly assigned to immediately start the Senyo intervention compared to a waitlist control group of 30 participants who will start the active intervention after a 12-week delay. RESULTS: The Senyo Health app was launched in May 2023, and the most recent update was in August 2024. Our funding period began in September 2023 and will conclude in July 2027. This protocol defines a novel implementation strategy for leveraging a digitally native, clinical platform that enables the delivery of CoCM to target an SUD-specific patient population. Our trial will begin in June 2025. CONCLUSIONS: We present a theory of change and study design to assess the impact of a novel and patient-centered mobile app to support the SBIRT approach to SUD in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT06743282; http://clinicaltrials.gov/ct2/show/NCT06743282. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/65693.