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Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence (HEAL Together)

Primary Purpose

Substance-Related Disorders, Opioid Medication Assisted Treatment, Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Delivered Behavioral Activation ("Peer Activate")
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Disease, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records
  • 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

Sites / Locations

  • University of Maryland Baltimore (UMD Drug Treatment Center)Recruiting
  • University of Maryland College Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer-Delivered Behavioral Activation ("Peer Activate")

Treatment As Usual

Arm Description

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.

Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact).

Outcomes

Primary Outcome Measures

MT Retention
Defined dichotomously as retention (yes/no) in methadone treatment
MT Persistence
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)

Secondary Outcome Measures

Intervention Feasibility Measured by Intervention Initiation
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. We will also collect qualitative feedback relating to feasibility.
Intervention Acceptability Measured by Intervention Attendance
Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend ≥75% sessions. We will also collect qualitative feedback relating to acceptability.
Intervention Fidelity Measured by Independent Rating
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 we will assess the % of intervention components delivered as intended.
MT Retention
Defined dichotomously as retention (yes/no) in methadone treatment
MT Persistence
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Changes in substance use
Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back)

Full Information

First Posted
March 17, 2022
Last Updated
July 5, 2023
Sponsor
University of Maryland, College Park
Collaborators
University of Maryland, Baltimore, Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05299515
Brief Title
Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence
Acronym
HEAL Together
Official Title
Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
University of Maryland, Baltimore, Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, minority 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 Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months.
Detailed Description
The opioid use disorder (OUD) crisis disproportionately affects low-income, racial/ethnic minorities. There is a pressing need to improve retention in medication for opioid use disorder (MOUD), particularly among low-income, racial/ethnic minorities. Training peer recovery specialists (PRSs), individuals with their own lived experience with substance use disorder (SUD), in evidence-based interventions (EBIs) may be a promising strategy to improve MOUD retention for low-income, minority individuals with OUD. Yet, few EBIs have been evaluated for PRS delivery to promote MOUD retention. Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving MOUD retention for low-income, minority individuals with OUD. By targeting increases in positive reinforcement, BA has been found to be effective for improving SUD treatment retention, preventing future relapse, 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. Importantly for implementation, BA also is feasible and cost-effective using lay counselor delivery. Following from this prior research, BA is an ideal EBI to evaluate for improving MOUD retention using a PRS-delivered model. This Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) builds upon our team's formative work, as well as our recent open label-pilot (R61AT010799) to develop and pilot the PRS-delivered BA approach. Guided by Aarons' stage model and Proctor's model of implementation, we proposed a mixed-methods, Type 1 hybrid effectiveness-implementation study to evaluate implementation and the effectiveness of the intervention on MT retention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Opioid Medication Assisted Treatment, Opioid Use Disorder, Opioid Use, Opioid Addiction, Treatment Adherence, Retention in Care
Keywords
Disease, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in parallel to receive either the Peer Activate intervention or treatment as usual (TAU: weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact). Assessments will take place for both groups at baseline, at an approximately 3-month follow-up (or at completion/discontinuation of the intervention), and at an approximately 6-month follow-up (or at 3 months after completion/discontinuation of the intervention).
Masking
Outcomes Assessor
Masking Description
At the approximately 3-Month (or at completion/discontinuation of intervention) and approximately 6-Month Follow-Up assessments (or approximately 3 months after 3-month follow up assessment or at discontinuation of intervention), a trained and blinded member of the research team will complete assessments with the participant.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer-Delivered Behavioral Activation ("Peer Activate")
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact).
Intervention Type
Behavioral
Intervention Name(s)
Peer-Delivered Behavioral Activation ("Peer Activate")
Intervention Description
The PRS-delivered Peer Activate intervention will consist of approximately four weekly "core" sessions (approximately 30 minutes-1 hour) with two additional sessions to reinforce core content, and then 6 optional "booster" sessions to reinforce skill practice. In Peer Activate sessions, participants will learn behavioral activation and problem-solving skills to assist in their retention and persistence in methadone treatment and incorporating value-driven, substance-free, rewarding activities into their daily life.
Primary Outcome Measure Information:
Title
MT Retention
Description
Defined dichotomously as retention (yes/no) in methadone treatment
Time Frame
Measured at final follow up (approximately six-months post-baseline assessment)
Title
MT Persistence
Description
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Time Frame
Measured at final follow up (approximately six-months post-baseline)
Secondary Outcome Measure Information:
Title
Intervention Feasibility Measured by Intervention Initiation
Description
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. We will also collect qualitative feedback relating to feasibility.
Time Frame
Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
Title
Intervention Acceptability Measured by Intervention Attendance
Description
Acceptability, defined as satisfaction with or tolerability of the proposed approach, will be measured quantitatively by session attendance. Specifically, we will measure the % of patients enrolled who attend ≥75% sessions. We will also collect qualitative feedback relating to acceptability.
Time Frame
Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
Title
Intervention Fidelity Measured by Independent Rating
Description
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 we will assess the % of intervention components delivered as intended.
Time Frame
Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Title
MT Retention
Description
Defined dichotomously as retention (yes/no) in methadone treatment
Time Frame
Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Title
MT Persistence
Description
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Time Frame
Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Title
Changes in substance use
Description
Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back)
Time Frame
Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Other Pre-specified Outcome Measures:
Title
Change in depressive symptoms
Description
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Time Frame
Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)
Title
Change in depressive symptoms
Description
Patient Health Questionnaire-8 (PHQ-8). Possible score of 0 - 24, with higher scores indicating more depressive symptoms.
Time Frame
Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Title
Changes in substance use
Description
Assess prevalence of opioid use and other substance use (urinalysis and timeline followback)
Time Frame
Assessed between the baseline assessment and the acute posttreatment follow-up (approximately 3 months post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Initiated methadone at the study site in the past three months (and no less than two weeks prior to study enrollment) or demonstrated challenges with methadone adherence in the past three months as indicated by one or more of the following: a) at least one missing take-home bottle at the time of bottle return; b) screened negative for methadone in routinely administered clinic urinalysis tests; c) transitioned from an extended take-home bottle schedule to daily dosing schedule; or d) at least one missed methadone dose in the past 3 months as identified through clinic records 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie D Bradley, MPS
Phone
443-405-2849
Email
vbradley@umd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica F Magidson, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Baltimore (UMD Drug Treatment Center)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Healther Fitzsimons
Phone
443-462-3400
Email
hfitzsimons@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Melanie Bennett, PhD
First Name & Middle Initial & Last Name & Degree
Aaron Greenblatt, PhD
First Name & Middle Initial & Last Name & Degree
Annabelle M Belcher, PhD
Facility Name
University of Maryland College Park
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie D Bradley, MPS
Phone
443-405-2849
Email
vbradley@umd.edu
First Name & Middle Initial & Last Name & Degree
Jessica F Magidson, PhD
Phone
301-405-5095
Email
jmagidso@umd.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After all primary analyses are complete, de-identified data will be made available.
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Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence

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