Completed

Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

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What is being tested

Standard Aftercare Treatment

+ Motivational enhancement therapy (MET)

+ Contingency management

Behavioral
Who is being recruted

Mental Disorders

+ Chemically-Induced Disorders

+ Substance-Related Disorders

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorSt. Louis University
Last updated: April 4, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

About half of all individuals who receive treatment for substance use disorders (SUD) relapse within a year. Stress and an individual's biological response to it are significant predictors of relapse. Thus, interventions that decrease stress and normalize an individual's biological response to stress are desperately needed. Exercise decreases stress and improves the body's regulation of stress. The proposed project will utilize exercise as a novel relapse prevention intervention with individuals who have recently completed inpatient SUD treatment. This project will evaluate the efficacy of a motivational intervention for exercise in a randomized clinical trial of 150 SUD patients beginning Aftercare treatment at the VA St. Louis Health Care System. Participants will be randomized to one of two interventions: (1) standard care (SC), or (2) standard care plus a motivational intervention targeting exercise that lasts for six months. Participants are followed every three months for one year. Results from this study will advance exercise as a new strategy for enhancing stress regulation and prevention of relapse in SUD populations.

NCT01828307
Principal SponsorSt. Louis University
Last updated: April 4, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

147 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersChemically-Induced DisordersSubstance-Related Disorders

Criteria

8 inclusion criteria required to participate
Age 18 or older
Documented physician clearance to undergo exercise testing & exercise
Does not have high blood pressure
English speaking
Show More Criteria
9 exclusion criteria prevent from participating
Currently breastfeeding
Currently taking corticosteroids or hormonal contraceptives
In recovery for pathological gambling
Medical history in the past 6 months that contraindicates exercise
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Standard aftercare treatment consists of once per week group counseling for six months. Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.

Group II

Experimental
In addition to attending standard aftercare treatment, participants will receive three 50-minute motivational enhancement therapy sessions focused on exercise, plus 24 weekly contingency management sessions for exercise.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

VA St. Louis Health Care System - Jefferson Barracks Division

St Louis, United StatesOpen VA St. Louis Health Care System - Jefferson Barracks Division in Google Maps
CompletedOne Study Center