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Transforming Recovery Through Exercise and Community (TREC)

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ClinicalTrials.gov Identifier: NCT03065049
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital

Brief Summary:
The primary aim of this study is to develop a feasible, acceptable, and effective multilevel physical activity (PA) intervention that addresses both individual and interpersonal factors that can be easily scalable and delivered in the context of a methadone clinic. To do so, the investigators will train methadone maintenance treatment (MMT) patients who are already engaging in PA at public health recommended levels to deliver a group-based PA intervention to physically inactive MMT patients at a large community-based methadone clinic. Through the development of interpersonal relationships and social support, the investigators expect that MMT peers who have successfully navigated challenges associated with PA in this population (i.e. depression, smoking, triggers for drug use in environment) will help physically inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: TREC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peer-Facilitated Physical Activity Intervention Delivered During Methadone Maintenance
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Transforming Recovery with Exercise and Community (TREC)
Participants will engage in a 12-week physical activity intervention guided by a peer-facilitator at the methadone clinic they receive treatment. Participants will attend weekly groups, engage in a guided walking group, and utilize the Fitbit to self-monitor physical activity.
Behavioral: TREC
Participants will engage in a 12-week physical activity intervention guided by a peer-facilitator at the methadone clinic they receive treatment. Participants will attend weekly groups, engage in a guided walking group, and utilize the Fitbit to self-monitor physical activity.




Primary Outcome Measures :
  1. Minutes of moderate-to-vigorous physical activity (MVPA)/week [ Time Frame: 12 weeks ]
    Measured by accelerometry


Secondary Outcome Measures :
  1. Acceptability of the Intervention assessed with the Client Satisfaction Questionnaire [ Time Frame: 12 weeks ]
    Client Satisfaction Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • receiving MMT at SSTAR and planning to remain in treatment for the next 6 months
  • low active (i.e., less than 90 minutes of MIPA per week for the past 6 months)
  • has access to a computer connected to the internet or a smartphone compatible with the Fitbit application

Exclusion Criteria:

  • a history of psychotic disorder or current psychotic symptoms
  • current suicidality or homicidality
  • marked organic impairment according to responses to the diagnostic assessments
  • physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by methadone clinic physician)
  • current pregnancy or intent to become pregnant during the next 12 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065049


Contacts
Contact: Ana M Abrantes, Ph.D 401-455-6440 Ana_Abrantes@Brown.edu
Contact: Donnell Van Noppen, BA 401-455-6200 ext 21033 dvannoppen@butler.org

Locations
United States, Massachusetts
Stanley Street Treatment and Resources (SSTAR) Lifeline Recruiting
Fall River, Massachusetts, United States, 02724
Contact: Genie L Bailey, MD    508-235-7006    Genie_Bailey@Brown.edu   
Principal Investigator: Genie L Bailey, MD         
Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ana M Abrantes, Ph.D. Butler Hospital
Principal Investigator: Michael Stein, M.D. Boston University

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT03065049     History of Changes
Other Study ID Numbers: 1609-001
1R21DA041553-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Butler Hospital:
Physical Activity
Peer-facilitation
Methadone Maintenance Therapy

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents