Opioid Medication Assisted Treatment, Polysubstance Addiction, Retention in Care, Substance-Related Disorders, Treatment Adherence
Conditions
Keywords
Substance-Related Disorders, Opioid-Related Disorders, Polysubstance Use, Mental disorders
Brief summary
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in underserved areas. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.
Detailed description
There is a significant burden of opioid and polysubstance use within the US. Yet many communities are poorly equipped to meet the pressing need for addiction treatment, including medications for OUD (MOUD) and evidence-based interventions (EBIs) to address the rise in opioid use disorder (OUD) and co-occurring stimulant use. The availability of telemedicine has helped fill the void of practitioners by providing buprenorphine for OUD treatment in underserved areas, however, OUD treatment retention remains an ongoing challenge, with polysubstance use and stimulant use exacerbating this. Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use disorder (SUD) and recovery, are a promising strategy to improve OUD treatment retention and polysubstance use at these sites using a reinforcement-based approach. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving OUD treatment retention and reducing polysubstance use in underserved areas. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, including for stimulant use specifically, and improving medication adherence (i.e., for HIV) among low-income, minority populations with SUD as well as depression, which is a barrier to MOUD retention. BA has been shown to be feasibly delivered by peers and community health workers. This study proposes to evaluate the effectiveness, implementation, and cost-effectiveness of an adapted PRS-delivered BA approach on the TM-MTU ("Peer Activate-MTU") compared to enhanced treatment as usual (ETAU; facilitated referrals and general PRS support) for patients with OUD and other polysubstance use receiving telemedicine buprenorphine. The investigators propose a randomized Type 1 hybrid effectiveness-implementation trial (n=160) to evaluate Peer Activate-MTU compared to ETAU. Specific aims are to evaluate the effectiveness of Peer Activate-MTU over 12-months on OUD treatment retention and polysubstance use. The investigators will also evaluate the implementation of Peer-Active-MTU, including feasibility, acceptability, fidelity, and adoption guided by RE-AIM.
Interventions
BEHAVIORALPeer-Delivered Behavioral Activation ("Peer Activate")
The PRS-delivered Peer Activate intervention will consist of approximately six weekly "core" sessions (approximately 30 minutes-1 hour), and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to reduce barriers to medication nonadherence and incorporate value-driven, substance-free, rewarding activities into their daily life to reduce polysubstance use and improve retention.
Sponsors
University of Maryland, College Park
University of Maryland, Baltimore
Weill Medical College of Cornell University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
At 3-month, 6-month and 12-months following the baseline assessment, a trained and randomization-blinded member of the research team will complete assessments with the participant.
Intervention model description
Participants will be randomized in parallel to receive either the Peer Activate intervention on the MTU or enhanced treatment as usual (TAU: treatment as usual services on the MTU in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at a midpoint (1-month), and follow ups at 3-month, 6-month and 12-months following the baseline assessment. Follow up assessments will be conducted by a blinded assessor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient participants in the RCT must be 18 or older; receive OUD treatment as part of the telemedicine program; and exhibit polysubstance use within the past three-months (i.e., use of one or more non-prescribed substances (excluding opioids and/or tobacco) by urine toxicology or self-report.
Exclusion criteria
* Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation * Inability to understand the study and provide informed consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Month Polysubstance Use Urinalysis | Measured from baseline to 6-month follow-up | Polysubstance use will be assessed using urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. |
| Six-Month Polysubstance Use Self Report | Assessed between the baseline assessment 6-month follow-up | The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-month OUD Treatment Retention | Measured from intake through 6-month follow up | Retention is measured using chart review of clinic records of appointment attendance. Retention will be assessed measured as dichotomous retention (yes/no) at six months post MOUD initiation. |
| Six-month Buprenorphine Adherence | Measured from intake to six-month follow-up | Buprenorphine adherence will be assessed through urinalysis. Urine samples are collected at each visit and sent out for toxicological analysis using a customized panel composed of 40 analytes, including both qualitative and quantitative results for opioids, stimulants, benzodiazepines, alcohol, marijuana, hallucinogens, methadone, buprenorphine and norbuprenorphine. Continuity of pharmacy for MOUD through 6 months will be assessed and calculated via the percent retained on MT for at least 6 months, defined as having one or more additional MOUD-related visits for each 30-day period up to 6 months. |
| Six-month Self-Report Buprenorphine Adherence | Assessed between the baseline assessment and 6-month follow-up | The IRA Wilson will be utilized to assess self-report buprenorphine adherence |
| Six-Month Problems Associated with Substance Use | Assessed between the baseline assessment and 6-month follow-up | Problems associated with use will be assessed using the Short Inventory of Problems (SIP), a 15-item measure that will be used to assess five domains of impairment related to polysubstance use. |
| Intervention Uptake | Assessed between the baseline assessment and 6-month follow-up | Feasibility, defined as the suitability and practicability of the approach, will be measured quantitatively as the % of patients who agree to participate in the intervention. |
| Intervention Session Attendance | Assessed between the baseline assessment 6-month follow-up | Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, % of patients enrolled who attend ≥75% sessions will be measured. |
| Intervention Fidelity | Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment) | Fidelity, defined as the delivery of the intervention as intended, will be measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions will be rated for fidelity by an independent rater, and % of intervention components delivered as intended will be measured. |
Countries
United States
Contacts
CONTACTMorgan S Anvari, BA
PRINCIPAL_INVESTIGATORJessica F Magidson, PhD
University of Maryland, College Park
PRINCIPAL_INVESTIGATORSarah M Kattakuzhy, MD
University of Maryland, Baltimore
Outcome results
None listed