Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

April 2, 2019 updated by: Jeremiah Weinstock, St. Louis University
Relapse contributes significantly to the chronicity of substance use disorders, one of the most costly medical/mental health problems facing our nation. The incorporation of exercise into relapse prevention efforts will address stress, a critical factor in relapse, provide other health benefits, and improve overall quality of life. Combined, these changes will reduce the risk of relapse to substance use while also lessening the burden of this psychiatric disorder upon society

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63125-4101
        • VA St. Louis Health Care System - Jefferson Barracks Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing residential substance use disorders treatment at VA St. Louis Healthcare System
  • Age 18 or older
  • English speaking;
  • Substance dependence
  • Recent substance use
  • Does not have high blood pressure
  • Documented physician clearance to undergo exercise testing & exercise
  • Plans to begin Aftercare at the clinic within the next two weeks

Exclusion Criteria:

  • Severely disruptive behavior
  • Serious uncontrolled psychiatric disorder
  • Medical history in the past 6 months that contraindicates exercise
  • Pregnancy, plans to get pregnant in the next six months.
  • Currently breastfeeding
  • Obese - class II
  • Currently taking corticosteroids or hormonal contraceptives
  • In recovery for pathological gambling
  • Opiate dependence.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Aftercare Treatment
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.
Behavioral: Standard Aftercare Treatment
Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.
Experimental: Standard Aftercare Treatment + Exercise Intervention
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.
Behavioral: Standard Aftercare Treatment
Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.
Behavioral: Motivational enhancement therapy (MET)
MET is a client-centered, directive method of enhancing intrinsic motivation for change by exploring and resolving ambivalence. In this intervention MET will focus on exercise.
Behavioral: Contingency management
Contingency management is a behavioral treatment that utilizes extrinsic motivation by offering individuals tangible rewards such as prizes for completion of specific target behaviors. The target behavior in this study is exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in substance use (relapse)
Time Frame: At baseline and every three months for one year.
Relapse is assessed during the duration of the study and is a time to event variable so it will be assess over time. Relapse is defined as drinking alcohol in excess of the National Institute on Alcohol Abuse and Alcohol (NIAAA) at-risk guidelines.
At baseline and every three months for one year.
Change in moderate to vigorous physical activity
Time Frame: At baseline and every three months for one year.
Moderate to vigorous physical activity frequency, duration and intensity will be assessed over time to examine changes in response to the intervention. Frequency is defined as how often and individual engages in moderate to vigorous physical activity. Duration is the amount of time (minutes) per episode that individual engages in moderate to vigorous physical activity. Intensity is defined two ways: (1) self-report rating of intensity and (2) metabolic equivalent of the moderate to vigorous physical activity.
At baseline and every three months for one year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in stress reactivity over time.
Time Frame: At baseline and two additional times over one year.
Stress reactivity is assess via a standardized psychosocial stressor paradigm that induces stress. Stress is assessed via salivary cortisol and self-report of stress.
At baseline and two additional times over one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Louis University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VA St. Louis Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeremiah Weinstock, PhD, St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DA033411-01A1 (U.S. NIH Grant/Contract)
  • 23298 (Other Identifier: Saint Louis University Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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