Clinical trial NCT01828307: Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: VA St. Louis Health Care System
First posted: 2013-04-10
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in substance use (relapse)
timeFrame: At baseline and every three months for one year.
measure: Change in moderate to vigorous physical activity
timeFrame: At baseline and every three months for one year.
Secondary outcomes:
measure: Change in stress reactivity over time.
timeFrame: At baseline and two additional times over one year.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: VA St. Louis Health Care System - Jefferson Barracks Division
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jeremiah Weinstock, PhD
role: PRINCIPAL_INVESTIGATOR
References: