Substance-Related DisordersHEAL TogetherNCT05299515
Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence
A study testing Peer-Delivered Behavioral Activation ("Peer Activate") in people with Substance-Related Disorders and Opioid Medication Assisted Treatment, run by University of Maryland, College Park at 2 sites in United States.
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, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders, Opioid Medication Assisted Treatment, Opioid Use Disorder
- What is being tested?
- Peer-Delivered Behavioral Activation ("Peer Activate")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2022to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Baltimore (UMD Drug Treatment Center)
Baltimore, Maryland, 21223
University of Maryland College Park
College Park, Maryland, 20742
About this study
Official title: Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
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.
Read the 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.
- Conditions
- Substance-Related Disorders, Opioid Medication Assisted Treatment, Opioid Use Disorder, Opioid Use, Opioid Addiction, Treatment Adherence
- Being tested
- Peer-Delivered Behavioral Activation ("Peer Activate")
- Keywords
- Disease, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Treatment Adherence and Compliance, Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Delivered Behavioral Activation ("Peer Activate")Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate") |
| Treatment As Usual | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
MT Retention
Defined dichotomously as retention (yes/no) in methadone treatment
Measured: Measured at final follow up (approximately six-months post-baseline assessment)
MT Persistence
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Measured: Measured at final follow up (approximately six-months post-baseline)
Secondary outcomes (6)
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.
Measured: Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
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.
Measured: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
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.
Measured: Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Retention
Defined dichotomously as retention (yes/no) in methadone treatment
Measured: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Persistence
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
Measured: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Changes in substance use
Assess prevalence of opioid use and other substance use (urinalysis and timeline follow back)
Measured: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start5 Apr 2022
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, Henry Ford Health System
- Responsible party
- Sponsor
- Investigators
- Jessica F Magidson, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299515
- Sponsor's protocol ID
- 1816868
- Acronym
- HEAL Together
- Status last verified
- Oct 2025
- First submitted
- 17 Mar 2022
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all primary analyses are complete, de-identified data will be made available.
Publications
Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
PubMed 21197565Carroll KM, Nich C, Frankforter TL, Yip SW, Kiluk BD, DeVito EE, Sofuoglu M. Accounting for the uncounted: Physical and affective distress in individuals dropping out of oral naltrexone treatment for opioid use disorder. Drug Alcohol Depend. 2018 Nov 1;192:264-270. doi: 10.1016/j.drugalcdep.2018.08.019. Epub 2018 Oct 4.
PubMed 30300800Daughters 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.
PubMed 21709737Daughters 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.
PubMed 28963853Ekers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011 Jan;198(1):66-72. doi: 10.1192/bjp.bp.110.079111.
PubMed 21200079Ekers D, Webster L, Van Straten A, Cuijpers P, Richards D, Gilbody S. Behavioural activation for depression; an update of meta-analysis of effectiveness and sub group analysis. PLoS One. 2014 Jun 17;9(6):e100100. doi: 10.1371/journal.pone.0100100. eCollection 2014.
PubMed 24936656Magidson 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.
PubMed 21310539Magidson 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.
PubMed 25419102Magidson JF, Joska JA, Regenauer KS, et al Adapting evidence-based, peer-delivered substance use treatment for HIV care in South Africa. Society of Behavioral Medicine New Orleans, LA, 2018.
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.
PubMed 27478619Mimiaga 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.
PubMed 23030605Mimiaga MJ, Closson EF, Pantalone DW, Safren SA, Mitty JA. Applying behavioral activation to sustain and enhance the effects of contingency management for reducing stimulant use among individuals with HIV infection. Psychol Health Med. 2019 Mar;24(3):374-381. doi: 10.1080/13548506.2018.1515492. Epub 2018 Sep 13.
PubMed 30211620Mitchell SG, Kelly SM, Gryczynski J, Myers CP, Jaffe JH, O'Grady KE, Olsen YK, Schwartz RP. African American patients seeking treatment in the public sector: characteristics of buprenorphine vs. methadone patients. Drug Alcohol Depend. 2012 Apr 1;122(1-2):55-60. doi: 10.1016/j.drugalcdep.2011.09.009. Epub 2011 Sep 29.
PubMed 21962726Proctor 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.
PubMed 20957426Richards 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.
PubMed 27461440
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MT Among Low-Income, Minority Individuals With OUD
- ClinicalTrials.gov ID
- NCT05299515
- Acronym / sponsor ID
- HEAL Together / 1816868
- Conditions
- Substance-Related Disorders, Opioid Medication Assisted Treatment, Opioid Use Disorder, Opioid Use, Opioid Addiction, Treatment Adherence
- Keywords
- Disease, Substance-Related Disorders, Opioid-Related Disorders, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, Henry Ford Health System
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Peer-Delivered Behavioral Activation ("Peer Activate") | Experimental | Behavioral: Peer-Delivered Behavioral Activation ("Peer Activate")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. |
| Treatment As Usual | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Delivered Behavioral Activation ("Peer Activate")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. | Behavioural | Peer-Delivered Behavioral Activation ("Peer Activate") |
Primary outcome
MT Retention
Time frame: Measured at final follow up (approximately six-months post-baseline assessment)
Defined dichotomously as retention (yes/no) in methadone treatment
MT Persistence
Time frame: Measured at final follow up (approximately six-months post-baseline)
Calculated as the proportion retained on MT monthly (i.e., at least one methadone dose for each 30 day period)
6 secondary outcomes
Intervention Feasibility Measured by Intervention Initiation
Time frame: Assessed at the post-treatment follow-up (approximately 3-months post-baseline assessment)
Intervention Acceptability Measured by Intervention Attendance
Time frame: Assessed at the acute post-treatment follow-up (approximately 3-months post-baseline assessment)
Intervention Fidelity Measured by Independent Rating
Time frame: Assessed at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Retention
Time frame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
MT Persistence
Time frame: Measured at the acute posttreatment follow-up (approximately 3-months post-baseline assessment)
Changes in substance use
Time frame: Assessed between the baseline assessment and the final follow-up (approximately 6 months post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Background: PubMed 21197565Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
- Background: PubMed 30300800Carroll KM, Nich C, Frankforter TL, Yip SW, Kiluk BD, DeVito EE, Sofuoglu M. Accounting for the uncounted: Physical and affective distress in individuals dropping out of oral naltrexone treatment for opioid use disorder. Drug Alcohol Depend. 2018 Nov 1;192:264-270. doi: 10.1016/j.drugalcdep.2018.08.019. Epub 2018 Oct 4.
- Background: PubMed 21709737Daughters 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.
- Background: PubMed 28963853Daughters 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.
- Background: PubMed 21200079Ekers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011 Jan;198(1):66-72. doi: 10.1192/bjp.bp.110.079111.
- Background: PubMed 24936656Ekers D, Webster L, Van Straten A, Cuijpers P, Richards D, Gilbody S. Behavioural activation for depression; an update of meta-analysis of effectiveness and sub group analysis. PLoS One. 2014 Jun 17;9(6):e100100. doi: 10.1371/journal.pone.0100100. eCollection 2014.
- Background: PubMed 21310539Magidson 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.
- Background: PubMed 25419102Magidson 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.
- BackgroundMagidson JF, Joska JA, Regenauer KS, et al Adapting evidence-based, peer-delivered substance use treatment for HIV care in South Africa. Society of Behavioral Medicine New Orleans, LA, 2018.
- Background: PubMed 27478619Magidson 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.
- Background: PubMed 23030605Mimiaga 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.
- Background: PubMed 30211620Mimiaga MJ, Closson EF, Pantalone DW, Safren SA, Mitty JA. Applying behavioral activation to sustain and enhance the effects of contingency management for reducing stimulant use among individuals with HIV infection. Psychol Health Med. 2019 Mar;24(3):374-381. doi: 10.1080/13548506.2018.1515492. Epub 2018 Sep 13.
- Individual participant dataSharing planned: Yes. After all primary analyses are complete, de-identified data will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica F Magidson, PhD principal investigator
University of Maryland, College Park
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Delivered Behavioral Activation ("Peer Activate") in people with Substance-Related Disorders and Opioid Medication Assisted Treatment, run by University of Maryland, College Park at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MT Retention (time frame: Measured at final follow up (approximately six-months post-baseline assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299515, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.