Peer Recovery to Improve Polysubstance Use and Mobile Telemedicine Retention

NCT05973838 | Recruiting DMC

• 2 other identifiers: 1953327R01DA057443
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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.

Conditions

Polysubstance Addiction; Opioid Medication Assisted Treatment; Treatment Adherence; Retention in Care; Substance-Related Disorders

Keywords

Substance-Related Disorders; Opioid-Related Disorders; Polysubstance Use; Mental disorders

Outcome Measures

Primary Outcomes (2)

• Six-Month Polysubstance Use Urinalysis

  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.

  Measured from baseline to 6-month follow-up

• Six-Month Polysubstance Use Self Report

  The New York University (NYU) polysubstance use measurement tool will be utilized to assess polysubstance frequency.

  Assessed between the baseline assessment 6-month follow-up

Secondary Outcomes (7)

• Six-month OUD Treatment Retention

  Measured from intake through 6-month follow up

• Six-month Buprenorphine Adherence

  Measured from intake to six-month follow-up

• Six-month Self-Report Buprenorphine Adherence

  Assessed between the baseline assessment and 6-month follow-up

• Six-Month Problems Associated with Substance Use

  Assessed between the baseline assessment and 6-month follow-up

• Intervention Uptake

  Assessed between the baseline assessment and 6-month follow-up

Other Outcomes (18)

• Three-month OUD Treatment Retention

  Measured from intake through 3-month follow up

• Three-Month Polysubstance Use Urinalysis

  Measured from baseline to 3-month follow-up.

• Three-Month Polysubstance Use Self Report

  Measured from baseline to 3-month follow-up.

Study Arms (2)

Peer-Delivered Behavioral Activation ("Peer Activate")

EXPERIMENTAL

Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.

Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")

Treatment As Usual

NO INTERVENTION

Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.

Interventions

Peer-Delivered Behavioral Activation ("Peer Activate") BEHAVIORAL

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.

Peer-Delivered Behavioral Activation ("Peer Activate")

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead
• University of Maryland, Baltimore: collaborator
• Weill Medical College of Cornell University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

HIPS Clinic

Washington D.C., District of Columbia, 20002, United States

NOT YET RECRUITING

University of Maryland Baltimore (UMD Drug Treatment Center)

Baltimore, Maryland, 21223, United States

NOT YET RECRUITING

University of Maryland, College Park

College Park, Maryland, 20742, United States

NOT YET RECRUITING

Caroline County Behavioral Health

Denton, Maryland, 21629, United States

RECRUITING

Related Publications (17)

• Ghertner R. U.S. trends in the supply of providers with a waiver to prescribe buprenorphine for opioid use disorder in 2016 and 2018. Drug Alcohol Depend. 2019 Nov 1;204:107527. doi: 10.1016/j.drugalcdep.2019.06.029. Epub 2019 Aug 30.

  PMID: 31525570 BACKGROUND

• Magidson JF, Gorka SM, MacPherson L, Hopko DR, Blanco C, Lejuez CW, Daughters SB. Examining the effect of the Life Enhancement Treatment for Substance Use (LETS ACT) on residential substance abuse treatment retention. Addict Behav. 2011 Jun;36(6):615-623. doi: 10.1016/j.addbeh.2011.01.016. Epub 2011 Jan 21.

  PMID: 21310539 BACKGROUND

• Mimiaga MJ, Reisner SL, Pantalone DW, O'Cleirigh C, Mayer KH, Safren SA. A pilot trial of integrated behavioral activation and sexual risk reduction counseling for HIV-uninfected men who have sex with men abusing crystal methamphetamine. AIDS Patient Care STDS. 2012 Nov;26(11):681-93. doi: 10.1089/apc.2012.0216. Epub 2012 Oct 3.

  PMID: 23030605 BACKGROUND

• Mimiaga MJ, Pantalone DW, Biello KB, Hughto JMW, Frank J, O'Cleirigh C, Reisner SL, Restar A, Mayer KH, Safren SA. An initial randomized controlled trial of behavioral activation for treatment of concurrent crystal methamphetamine dependence and sexual risk for HIV acquisition among men who have sex with men. AIDS Care. 2019 Sep;31(9):1083-1095. doi: 10.1080/09540121.2019.1595518. Epub 2019 Mar 19.

  PMID: 30887824 BACKGROUND

• Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.

  PMID: 28963853 BACKGROUND

• Magidson JF, Seitz-Brown CJ, Safren SA, Daughters SB. Implementing Behavioral Activation and Life-Steps for Depression and HIV Medication Adherence in a Community Health Center. Cogn Behav Pract. 2014 Nov 1;21(4):386-403. doi: 10.1016/j.cbpra.2013.10.002.

  PMID: 25419102 BACKGROUND

• Magidson JF, Joska JA, Regenauer KS, Satinsky E, Andersen LS, Seitz-Brown CJ, Borba CPC, Safren SA, Myers B. "Someone who is in this thing that I am suffering from": The role of peers and other facilitators for task sharing substance use treatment in South African HIV care. Int J Drug Policy. 2019 Aug;70:61-69. doi: 10.1016/j.drugpo.2018.11.004. Epub 2019 May 10.

  PMID: 31082664 BACKGROUND

• Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.

  PMID: 21709737 BACKGROUND

• Tull MT, Berghoff CR, Bardeen JR, Schoenleber M, Konkle-Parker DJ. An Initial Open Trial of a Brief Behavioral Activation Treatment for Depression and Medication Adherence in HIV-Infected Patients. Behav Modif. 2018 Mar;42(2):196-209. doi: 10.1177/0145445517723901. Epub 2017 Aug 11.

  PMID: 28799413 BACKGROUND

• Carroll KM. Lost in translation? Moving contingency management and cognitive behavioral therapy into clinical practice. Ann N Y Acad Sci. 2014 Oct;1327(1):94-111. doi: 10.1111/nyas.12501. Epub 2014 Sep 9.

  PMID: 25204847 BACKGROUND

• Magidson JF, Lejuez CW, Kamal T, Blevins EJ, Murray LK, Bass JK, Bolton P, Pagoto S. Adaptation of community health worker-delivered behavioral activation for torture survivors in Kurdistan, Iraq. Glob Ment Health (Camb). 2015 Dec;2:e24. doi: 10.1017/gmh.2015.22.

  PMID: 27478619 BACKGROUND

• Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.

  PMID: 27461440 BACKGROUND

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Mack KA, Jones CM, Ballesteros MF. Illicit Drug Use, Illicit Drug Use Disorders, and Drug Overdose Deaths in Metropolitan and Nonmetropolitan Areas-United States. Am J Transplant. 2017 Dec;17(12):3241-3252. doi: 10.1111/ajt.14555.

  PMID: 29145698 BACKGROUND

• Langabeer JR, Stotts AL, Cortez A, Tortolero G, Champagne-Langabeer T. Geographic proximity to buprenorphine treatment providers in the U.S. Drug Alcohol Depend. 2020 Aug 1;213:108131. doi: 10.1016/j.drugalcdep.2020.108131. Epub 2020 Jun 24.

  PMID: 32599495 BACKGROUND

• Magidson JF, Kleinman MB, Bradley V, Anvari MS, Abidogun TM, Belcher AM, Greenblatt AD, Dean D, Hines A, Seitz-Brown CJ, Wagner M, Bennett M, Felton JW. Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Int J Drug Policy. 2022 Oct;108:103813. doi: 10.1016/j.drugpo.2022.103813. Epub 2022 Aug 3.

  PMID: 35932644 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance; Substance-Related Disorders; Opioid-Related Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Chemically-Induced Disorders; Narcotic-Related Disorders

Study Officials

• Jessica F Magidson, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Sarah M Kattakuzhy, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan S Anvari, BA

CONTACT

3014055095; manvari@umd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: August 3, 2023
• Study Start: June 15, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)