Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

Substance Use Disorders Clinical Trial

— HEAL Together  

Official title:

Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MAT Among Low-Income, Minority Individuals With OUD - Pilot Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248933
• Other study ID #: 1531148
• Secondary ID: R61AT010799
• Status: Completed
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Opioid use disorder (OUD) disproportionately affects low-income, racial/ethnic minorities (Stahler, 2018). MOUD is efficacious for treating OUD. However, adherence to MOUD is often low, which includes poor treatment retention, especially among low-income, racial/ethnic minority individuals (Stahler, 2018;Williams, 2017). This may be due to barriers such as stigma, challenges navigating services, housing instability, fluctuating motivation and readiness, and other structural and psychosocial factors (Timko, 2016;Carroll, 2015). Peer recovery specialists (PRSs) may be uniquely suited to address these barriers to retention (Jack, 2017;Bassuk, 2016). PRSs are trained individuals who have a personal, lived experience with substance use. Using their lived experience, PRSs can support individuals with OUD to stay retained in care. Rapid increases in the use of PRSs nationwide demonstrate the appeal of employing PRSs as a potentially sustainable solution to support the behavioral treatment needs in OUD care. Yet, few evidence-based interventions have been evaluated for PRS delivery to promote MOUD retention. Prior research has been inconclusive regarding psychosocial interventions to support MOUD retention (Timko, 2016; Carroll, 2017). Reinforcement-based approaches, such as contingency management, have empirical support for improving MOUD retention, but also can have low adoption in community settings due to organizational and provider barriers, including cost in medically underserved areas (Timko, 2016; Carroll, 2017; Carroll, 2015). Successful interventions need to be not only effective in improving MOUD retention, but also be feasible and sustainable to deliver for underserved populations. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD (Magidson, 2011). Originally developed as an efficacious treatment for depression, BA aims to increase positive reinforcement by promoting engagement in adaptive, valued behaviors (Lejuez, 2011). By targeting increases in positive reinforcement, BA has been effective in improving substance use disorder (SUD) treatment retention and preventing future relapse among low-income, minority individuals with SUD. Further, BA has improved medication adherence (i.e., for HIV) among low-income, minority populations with SUD, as well as depression, which may also be a barrier to MOUD retention. Importantly for implementation, BA has previously been implemented in low-resource settings (largely internationally) using lay health workers (e.g., peers, community health workers). However, to date, prior work has yet to evaluate a PRS-delivered BA intervention to support MOUD retention. This study builds upon formative work to adapt and evaluate PRS-delivered BA to support MOUD retention for low-income, minoritized individuals initiating methadone at an outpatient, opioid treatment program in a medically underserved community in Baltimore, Maryland (Magidson, 2011; Magidson, 2018; Satinsky, 2020). The current study has three phases, the first being formative, qualitative work, to adapt the proposed treatment approach. The second phase is a pilot trial (current phase). The pilot trial is an open-label, Type 1 hybrid effectiveness-implementation trial assessing the feasibility, acceptability, and fidelity (implementation outcomes) of a PRS-delivered BA intervention for MOUD retention in methadone treatment, and evaluating retention in the methadone program at three months (primary effectiveness outcome).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 31, 2022
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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
• Positive pregnancy status at enrollment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Peer-Delivered Behavioral Activation (Peer Activate)
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.

Locations

Country	Name	City	State
United States	University of Maryland Baltimore Drug Treatment Center	Baltimore	Maryland
United States	University of Maryland, College Park	College Park	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Center for Complementary and Integrative Health (NCCIH), University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Opioid Use	Assessed point prevalence of indicators of opioid use in urinalysis.	Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Other	Change in Methadone Use	Assessed point prevalence of indicators of methadone use in urinalysis.	Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Other	Change in Depressive Symptoms	Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.	Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Primary	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)
Primary	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	Intervention Acceptability: % of Patients Who Attend =75% Sessions	Acceptability, defined as satisfaction with or tolerability of the proposed approach, was measured quantitatively by session attendance. Specifically, we measured the % of patients who attended =75% of core intervention sessions.	Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)
Secondary	Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended	Fidelity, defined as the delivery of the intervention as intended, was measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions was rated for fidelity, and we assessed the % of intervention components delivered as intended.	Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)