Faculty Bibliography

Background/UNASSIGNED:Mobile health (mHealth) tools offer an effective and personalized approach to enhance chronic disease management and may partially offset provider-level barriers to increasing buprenorphine prescribing in primary care. This study assessed the feasibility of integrating a text messaging-based medical management tool (TeMeS) in primary care among patients initiating buprenorphine. Methods/UNASSIGNED:TeMeS messages are categorized per the medical management model, programed in a HIPAA-compliant texting software (Apptoto©), and delivered in a tiered fashion over 8-weeks to patients. This mixed-methods evaluation of TeMeS utilized key stakeholder feedback (patients, physicians, administrators, nursing), text messaging software process measures, thematic analysis of patient participant text message content, and electronic administrative data (eg, appointment adherence, treatment retention) at 2-months. Results/UNASSIGNED:The study team approached 65 patients and n = 14 (21%) were ineligible or declined to participate in the study. Most eligible participants owned a smartphone (90%), responded to at least one text query (88%) over an average of 24 days, and few requested to stop receiving texts (6%). Participant text replies included responses to cognitive behavioral therapy-based queries (13.8%), confirming or rescheduling appointments (6.1%), and insurance, pharmacy, or clinical issues pertaining to buprenorphine dispensation or dosing (2%). Suggestions for design modifications included personalizing message content and adjusting message frequency per patient risk of illicit opioid reuse, use of video-based informational content, and real-time provider and staff support for emergent issues. Conclusion/UNASSIGNED:Our findings highlight the acceptability, feasibility, and high rates of engagement of utilizing text messaging to enhance self-management among patients initiating buprenorphine treatment.

Chronic pain is highly prevalent among patients with opioid use disorder (OUD). However, little is known about how pharmacological treatments for OUD, for example, extended-release naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX), affect pain. To begin addressing this question, we performed a secondary analysis of pain data on a large prospective 24-week, open-label, randomized-controlled comparative effectiveness trial of XR-NTX versus BUP-NX (X:BOT trial). Participants' pain status was measured by the EuroQol (EQ-5D). Based on their responses to the pain question at baseline, participants were dichotomized into "Pain" versus "No Pain" categories. Participant's pain status was evaluated every 4 weeks. A mixed effects longitudinal logistic regression model was fitted to examine the differential effect of XR-NTX versus BUP-NX on pain, modelling pain at all available follow-up assessments, adjusted for age, sex, and baseline pain. A total of 474 individuals who were successfully inducted onto their assigned medications were included in this analysis. Among participants endorsing pain at baseline, substantial reductions in pain were observed over the course of the study in both treatment groups. Howecver reduction in pain was slightly greater in the group treated with XR-NTX than the one treated with BUP-NX (OR = 1.60 [95% CI: 1.07-2.40], P = 0.023). Future research using instruments and design specifically focused on pain could extend the present observations and evaluate their clinical significance.

BACKGROUND AND AIMS/OBJECTIVE:In a US randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72% XR-NTX versus 94% BUP-NX). DESIGN/METHODS:This was a retrospective secondary analysis of CTN-0051 trial data, including follow-up data over 24-36 weeks. SETTING/METHODS:Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the United States. PARTICIPANTS/METHODS:A total of 283 participants randomized to receive XR-NTX. MEASUREMENTS/METHODS:Efficiency was estimated using a multivariable generalized structural equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the health-care sector perspective and included expected costs and quality-adjusted life-years (QALYs). FINDINGS/RESULTS:Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5317 more than that of BUP-NX (P = 0.01) to a non-statistically-significant difference of $1016 (P = 0.63). QALYs gained remained similar across arms. CONCLUSION/CONCLUSIONS:Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the health-care sector perspective over 24-36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.

BACKGROUND:The randomized X:BOT trial showed that following induction, sublingual agonist (buprenorphine-naloxone, BUP-NX) or antagonist injection (extended release naltrexone, XR-NTX) produced similar benefits for reducing opioid relapse in injection users with opioid use disorder. Given that XR-NTX reduces drinking in alcohol use disorder (AUD), we completed a secondary analysis of the X:BOT sample of patients successfully inducted onto treatment to determine if XR-NTX (n=204) was superior to BUP-NX (n=270) to reduce drinking or heavy drinking in patients with opioid use disorder. METHODS:Timeline follow-back recorded standard drink units consumed. Mixed-models regression examined monthly frequencies of any drinking or heavy drinking over 6 months of treatment and proportional hazard survival examined time to first drink. RESULTS:Both treatment groups reduced drinking from baseline to post-treatment (small to medium effect), but no differences between groups were detected. However, only 29% (n=136) of the sample had AUD and 19% (n=26/136) of those were abstinent before treatment. Analysis of a subsample enriched for possible drinking included n=136 with an AUD diagnosis plus n=43 who did not have AUD, but reported at least one day of heavy drinking prior to study. Even so, this subsample still reported only 32% of days of any drinking with a median of only 13% of days designated as "heavy". Within this subsample, the BUP-NX group reported greater mean drinks per drinking day than did the XR-NTX group at baseline (p=0.03); however, there were no other significant group differences in drinking observed before, during, or at the end of treatment. CONCLUSIONS:An overall improvement in drinking occurred for treatment of OUD using both agonist and antagonist approaches indicating that the hypothesis that XR-NTX would be superior to BUP-NX was not supported. The study is limited by low levels of comorbid AUD or heavy drinking observed in X:BOT trial participants seeking treatment for opioid use disorder.

BACKGROUND:Relapse rates during opioid use disorder (OUD) treatment remain unacceptably high. It is possible that optimally matching patients with medication type would reduce risk of relapse. Our objective was to learn a rule by which to assign type of medication for OUD to reduce risk of relapse, and to estimate the extent to which risk of relapse would be reduced if such a rule were used. METHODS:This was a secondary analysis of an open-label randomized controlled, 24-week comparative effectiveness trial of injection extended-release naltrexone (XR-NTX), delivered approximately every 28 days, or daily sublingual buprenorphine-naloxone (BUP-NX) for treating OUD, 2014-2017 (N = 570). Outcome was a binary indicator of relapse to regular opioid use during the 24 weeks of outpatient treatment. RESULTS:We found that applying an estimated individualized treatment rule-i.e., a rule that assigns patients with OUD to either XR-NTX or BUP-NX based on their individual characteristics in such a way that risk of relapse is minimized-would reduce risk of relapse by 24 weeks by 12% compared to randomly assigned treatment. CONCLUSIONS:The number-needed-to-treat with the estimated treatment rule to prevent a single relapse is 14. A simpler, alternative estimated rule in which homeless participants would be treated with XR-NTX and stably housed participants would be treated with BUP-NX performed similarly. These results provide an estimate of the amount by which a relatively simple change in clinical practice could be expected to improve prevention of OUD relapse.

BACKGROUND:Risk of relapse within the first months after alcohol use disorder (AUD) interventions is substantial among older adults. For this vulnerable group, little information exists on how this risk is associated with residual DSM-5 AUD symptoms after treatment. AIMS/OBJECTIVE:To investigate among older adults who received short-term treatment for DSM-5 AUD (1) the prediction of drinking behaviors and quality of life 12 months after treatment initiation by 6-month DSM-5 AUD symptoms, AUD severity, and AUD remission, and (2) whether these DSM-5 AUD indicators provide prognostic information beyond that gained from 6-month alcohol use (AU) status. METHODS:The international multicenter RCT "ELDERLY-Study" enrolled adults aged 60+ with DSM-5 AUD. We used data from the subsample of 323 German and Danish participants with complete DSM-5 AUD criterion information 6 months after treatment initiation (61% male; mean age = 65.5 years). AU was assessed with Form 90, DSM-5 AUD with the M.I.N.I., and quality of life with the WHOQOL-BREF. Generalized linear models were applied to investigate the associations between 6-month AUD indicators and 12-month AU and quality of life. RESULTS:Independent of AU at 6 months, having 1 (vs. no) residual AUD symptom at 6 months predicted a 12-month "slip," defined as exceeding a blood alcohol concentration of 0.05% at least once during that time (OR: 3.7, 95% CI: 1.5 to 9.0), heavy episodic drinking, and hazardous use (p < 0.05). AUD remission was associated with a lower risk of a "slip" at 12 months (p < 0.05). Failed reduction/cessation was associated with poorer physical health (Coef.: -0.4, 95% CI -0.7 to -0.1). CONCLUSION/CONCLUSIONS:For older adults, residual AUD symptoms in the first months after short-term treatment predict problematic AU outcomes during the first 12 months after treatment entry. Thus, residual symptoms should be addressed in this patient population during posttreatment screenings.