Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

Substance Use Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828307
• Other study ID #: R01DA033411-01A1
• Secondary ID: 23298
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: March 2019

Study information

• Verified date: April 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA St. Louis Health Care System - Jefferson Barracks Division	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	VA St. Louis Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in substance use (relapse)	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.
Primary	Change in moderate to vigorous physical activity	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	Change in stress reactivity over time.	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.