Capturing the Full Range of Buprenorphine Treatment Response.

Importance: Reliance on abstinence-based treatment success rules may fail to capture the full continuum of treatment response to buprenorphine plus medical counseling (BUP+MC) for opioid use disorder (OUD).

Objective: To describe patterns of reduction in illicit opioid use of patients both labeled as a success and nonsuccess based on an abstinent-based treatment outcome rule.

Design, Setting, And Participants: This study is a secondary data analysis of 4 harmonized randomized clinical trials on BUP+MC for OUD from multiple sites that included 869 patients with OUD.

Racial and ethnic differences in self-reported barriers to substance use treatment among emergency department patients.

Background And Objectives: As overdose rates rise among non-White Americans, understanding barriers to substance use disorder (SUD) treatment access by race and ethnicity is important. This study explores self-reported barriers to SUD treatment by race and ethnicity in emergency department (ED) populations.

Methods: We conducted a secondary, exploratory analysis of a randomized trial of patients not seeking SUD treatment who endorsed active drug use at six academic EDs.

Toward AI-driven neuroepigenetic imaging biomarker for alcohol use disorder: A proof-of-concept study.

Alcohol use disorder (AUD) is a disorder of clinical and public health significance requiring novel and improved therapeutic solutions. Both environmental and genetic factors play a significant role in its pathophysiology. However, the underlying epigenetic molecular mechanisms that link the gene-environment interaction in AUD remain largely unknown.

Developing a remotely delivered intensive outpatient program adapted for hospitalized patients with opioid use disorder: A qualitative study.

Introduction: Individuals with opioid use disorder (OUD) who inject drugs have an elevated risk of experiencing serious injection-related infections. While such infections can be treated, treatment for the underlying OUD is often limited. One potential strategy for more intensive addiction treatment is to offer a remotely delivered intensive outpatient program (IOP), adapted from an existing remote IOP ("Smart IOP").

Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial.

Introduction And Background: Buprenorphine, and extended-release naltrexone, are effective in decreasing opioid use, morbidity and mortality. The available evidence suggests that these medications should be used for long term treatment; however, patients often ask how long they need to be on medication, and whether it would be safe to discontinue. There are sparse data to guide us.

Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial.

Background: The U.S. opioid overdose crisis persists.

Protocol for harmonization of randomized trials testing the addition of behavioral therapy to buprenorphine for opioid use disorder.

Background: Although buprenorphine is an effective treatment for opioid use disorder (OUD), much remains to be understood about treatment non-response and methods for improving treatment retention. The addition of behavioral therapies to buprenorphine has not yielded consistent benefits for opioid outcomes, on average. However, several studies suggest that certain subgroups may benefit from the combination of buprenorphine and behavioral therapy, highlighting the potential for personalized approaches to treatment.

Cognitive behavioral therapy for anxiety and opioid use disorder: Development and pilot testing.

Introduction: Anxiety disorders are highly prevalent among people with opioid use disorder (OUD), and they have a negative impact on disorder course and treatment outcomes. The objective of this Stage 1 A/1B behavioral treatment development trial was to develop a novel cognitive-behavioral therapy (CBT) protocol for co-occurring anxiety disorders and OUD.

Methods: Following a period of iterative manual development involving patient interviews and feedback from content experts, we tested a 12-session individual CBT protocol in a small, open pilot trial (N = 5).

Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT.

Background: Office-based opioid treatment with buprenorphine has emerged as a popular evidence-based treatment for opioid use disorder. Unfortunately, psychosocial stress, anxiety, pain, and co-morbid substance use increase patients' risk for relapse. We designed this study to compare the effects of complementing buprenorphine treatment with 24 weeks of a live-online Mindful Recovery Opioid Care Continuum (M-ROCC) group to a time and attention-matched, live-online Recovery Support Group (RSG) active control condition.

Individual-Level Risk Prediction of Return to Use During Opioid Use Disorder Treatment.

Importance: No existing model allows clinicians to predict whether patients might return to opioid use in the early stages of treatment for opioid use disorder.

Objective: To develop an individual-level prediction tool for risk of return to use in opioid use disorder.

Design, Setting, And Participants: This decision analytical model used predictive modeling with individual-level data harmonized in June 1, 2019, to October 1, 2022, from 3 multicenter, pragmatic, randomized clinical trials of at least 12 weeks' duration within the National Institute on Drug Abuse Clinical Trials Network (CTN) performed between 2006 and 2016.

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial.

Objectives: Patients with opioid use disorder (OUD) are increasingly being hospitalized for acute medical illnesses. Despite initiation of medications for OUD (MOUDs), many discontinue treatment after discharge. To evaluate whether a psychosocial intervention can improve MOUD retention after hospitalization, we conducted a pilot randomized controlled trial of a peer recovery coach intervention.

Multiple imputation for non-monotone missing not at random data using the no self-censoring model.

Although approaches for handling missing data from longitudinal studies are well-developed when the patterns of missingness are monotone, fewer methods are available for non-monotone missingness. Moreover, the conventional missing at random assumption-a natural benchmark for monotone missingness-does not model realistic beliefs about the non-monotone missingness processes (Robins and Gill, 1997). This has provided the impetus for alternative non-monotone missing not at random mechanisms.

Risks of returning to opioid use at treatment entry and early in opioid use disorder treatment: Role of non-opioid substances.

Objective: Patients in treatment with medications for opioid use disorder (MOUD) often report use of other substances in addition to opioids. Few studies exist that examine the relationship between use at treatment entry and early non-opioid use in opioid treatment outcome.

Methodology: We combined and harmonized three randomized, controlled MOUD clinical trials from the National Institutes of Drug Abuse (NIDA) Clinical Trials Network (CTN) (N=2197) and investigated the association of non-opioid substance use at treatment entry and during early treatment with a return to opioid use.

Methods for handling missing binary data in substance use disorder trials.

Missing data are a ubiquitous problem in longitudinal substance use disorder (SUD) clinical trials. In particular, the rates of missingness are often high and study participants often intermittently skip their scheduled outcome assessments, leading to so-called "non-monotone" missing data patterns. Moreover, when the primary outcome is a measure of substance use, study investigators often have strong prior beliefs based on their clinical experience that those participants with missing data are more likely to be using substances at those occasions, i.

Permutation Tests for Assessing Potential Non-Linear Associations between Treatment Use and Multivariate Clinical Outcomes.

In many psychometric applications, the relationship between the mean of an outcome and a quantitative covariate is too complex to be described by simple parametric functions; instead, flexible nonlinear relationships can be incorporated using penalized splines. Penalized splines can be conveniently represented as a linear mixed effects model (LMM), where the coefficients of the spline basis functions are random effects. The LMM representation of penalized splines makes the extension to multivariate outcomes relatively straightforward.

Impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder: A pilot, double-blind, placebo-controlled, randomized cross-over trial.

Introduction: Opioid use disorder (OUD) continues to be a significant public health concern. Medications for OUD (MOUD) such as buprenorphine reduce overdose mortality, but relapses occur often, leading to adverse outcomes. Preliminary data suggest that cannabidiol (CBD) may be a potential adjunctive treatment to MOUD by attenuating cue-reactivity.

Assessment of the Short Grit Scale in patients with substance use disorder: Psychometric properties and patient characteristics.

Recovery from substance use disorder requires sustained effort and perseverance. Hence, the resilience factor of grit may be important for people in recovery. Little research has been conducted on grit in patients with substance use disorder (SUD), especially in a large and varied sample.

Association of Household Opioid Availability With Opioid Overdose.

Importance: Previous studies that examined the role of household opioid prescriptions in opioid overdose risk were limited to commercial claims, did not include fatal overdoses, and had limited inclusion of household prescription characteristics. Broader research is needed to expand understanding of the risk of overdose.

Objective: To assess the role of household opioid availability and other household prescription factors associated with individuals' odds of fatal or nonfatal opioid overdose.

Specific polysubstance use patterns predict relapse among patients entering opioid use disorder treatment.

Introduction: While polysubstance use has consistently been associated with higher rates of relapse, few studies have examined subgroups with specific combinations and time course of polysubstance use (i.e., polysubstance use patterns).

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study.

Background: A mindfulness-based intervention that reduces comorbid pain, anxiety, and substance use during office-based opioid treatment (OBOT) could enhance retention and prevent overdose. We conducted a pilot study of the Mindful Recovery OUD Care Continuum (M-ROCC), a 24-week trauma-informed program with a motivationally-sensitive curriculum.

Methods: Patients prescribed buprenorphine (N = 18) enrolled in M-ROCC.

Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review.

Importance: Novel treatments for opioid use disorder (OUD) are needed to address both the ongoing opioid epidemic and long-standing barriers to existing OUD treatments that target the endogenous μ-opioid receptor (MOR) system. The goal of this review is to highlight unique clinical trial design considerations for the study of emerging treatments for OUD that address targets beyond the MOR system. In November 2019, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration sponsored a meeting to discuss the current evidence regarding potential treatments for OUD, including cannabinoids, psychedelics, sedative-hypnotics, and immunotherapeutics, such as vaccines.

Cannabidiol Effect on Cue-Induced Craving for Individuals with Opioid Use Disorder Treated with Buprenorphine: A Small Proof-of-Concept Open-Label Study.

Background: Opioid use disorder (OUD) remains a major public health concern. Despite the use of medications for OUD such as buprenorphine, the current gold-standard treatment, relapse in the context of increased craving remains common. Cannabidiol (CBD) has been shown to reduce cue-induced craving in individuals with OUD, but among those who were not receiving any buprenorphine treatment.