Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

NCT04248933 | Completed Results DMC

• 2 other identifiers: 1531148R61AT010799
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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) among low-income, minoritized individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.

Conditions

Substance Use; Substance Use Disorders; Opioid-use Disorder; Peer Delivered; Medication for Opioid Use Disorder (MOUD); Methadone Treatment; Retention in Care; Behavioral Activation

Keywords

Substance-Related Disorders; Medication Treatment for Opioid Use Disorder; Opioid Crisis; Epidemic, Opioid; Opioid Addiction; Treatment Adherence; Retention in Care

Outcome Measures

Primary Outcomes (2)

• MOUD Retention Rate: % of Patients Retained at 3 Months

  Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment.

  Measured daily from intake to post-treatment (approximately 12-weeks)

• Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention

  Feasibility, defined as the suitability and practicability of the approach, was measured quantitatively as the % of patients who agreed to participate in the intervention.

  Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

Secondary Outcomes (2)

• Intervention Acceptability: % of Patients Who Attend ≥75% Sessions

  Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

• Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended

  Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

Other Outcomes (3)

• Change in Opioid Use

  Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

• Change in Methadone Use

  Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

• Change in Depressive Symptoms

  Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

Study Arms (1)

Peer-Delivered Behavioral Activation ("Peer Activate")

EXPERIMENTAL

Participants received a peer recovery specialist-delivered behavioral activation (BA) intervention ("Peer Activate") to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention.

Behavioral: Peer-Delivered Behavioral Activation (Peer Activate)

Interventions

Peer-Delivered Behavioral Activation (Peer Activate) BEHAVIORAL

The Peer Activate intervention consisted of weekly one-hour BA sessions led by a peer recovery specialist (PRS) for up to 12 weekly sessions, with the first five being the core treatment sessions and content, and the subsequent seven designed to reinforce core content. In these sessions, participants received individualized support in learning skills to assist in their retention and persistence in methadone treatment and were guided through exercises aimed at incorporating substance-free, rewarding activities into their daily life.

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:

• Initiated methadone at the study site or demonstrated challenges with methadone adherence in the past three months (e.g., at least one indicator of a missed methadone dose)
• Minimum of 18 years old

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
• Positive pregnancy status at enrollment

Sponsors & Collaborators

• University of Maryland, College Park: lead
• University of Maryland, Baltimore: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

University of Maryland Baltimore Drug Treatment Center

Baltimore, Maryland, 21223, United States

Location

University of Maryland, College Park

College Park, Maryland, 20742, United States

Location

Related Publications (12)

• 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

• Stahler GJ, Mennis J. Treatment outcome disparities for opioid users: Are there racial and ethnic differences in treatment completion across large US metropolitan areas? Drug Alcohol Depend. 2018 Sep 1;190:170-178. doi: 10.1016/j.drugalcdep.2018.06.006. Epub 2018 Jul 11.

  PMID: 30041092 BACKGROUND

• Williams AR, Nunes E, Olfson M. To battle the opioid overdose epidemic, deploy the 'Cascade of Care' model. Health Affairs Blog 2017 doi: 10.1377/hblog20170313.059163. Epub: 2017 Mar 13.

  BACKGROUND

• Timko C, Schultz NR, Cucciare MA, Vittorio L, Garrison-Diehn C. Retention in medication-assisted treatment for opiate dependence: A systematic review. J Addict Dis. 2016;35(1):22-35. doi: 10.1080/10550887.2016.1100960. Epub 2015 Oct 14.

  PMID: 26467975 BACKGROUND

• Jack HE, Oller D, Kelly J, Magidson JF, Wakeman SE. Addressing substance use disorder in primary care: The role, integration, and impact of recovery coaches. Subst Abus. 2018;39(3):307-314. doi: 10.1080/08897077.2017.1389802. Epub 2017 Nov 13.

  PMID: 28991516 BACKGROUND

• Bassuk EL, Hanson J, Greene RN, Richard M, Laudet A. Peer-Delivered Recovery Support Services for Addictions in the United States: A Systematic Review. J Subst Abuse Treat. 2016 Apr;63:1-9. doi: 10.1016/j.jsat.2016.01.003. Epub 2016 Jan 13.

  PMID: 26882891 BACKGROUND

• Carroll KM, Weiss RD. The Role of Behavioral Interventions in Buprenorphine Maintenance Treatment: A Review. Am J Psychiatry. 2017 Aug 1;174(8):738-747. doi: 10.1176/appi.ajp.2016.16070792. Epub 2016 Dec 16.

  PMID: 27978771 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, 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

• Magidson JF, Regan S, Jack HE, Wakeman SE. Reduced hospitalizations and increased abstinence six months after recovery coach contact. American Society of Addiction Medicine. San Diego, CA, 2018.

  BACKGROUND

• Satinsky EN, Doran K, Felton JW, Kleinman M, Dean D, Magidson JF. Adapting a peer recovery coach-delivered behavioral activation intervention for problematic substance use in a medically underserved community in Baltimore City. PLoS One. 2020 Jan 31;15(1):e0228084. doi: 10.1371/journal.pone.0228084. eCollection 2020.

  PMID: 32004328 BACKGROUND

• Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.

  PMID: 21324944 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jessica Magidson
• Organization: University of Maryland, College Park

jmagidso@umd.edu

301-405-5095

Study Officials

• Jessica F Magidson, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 30, 2020
• Study Start: October 9, 2020
• Primary Completion: October 19, 2021
• Study Completion: January 31, 2022
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (2)