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Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828307
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
VA St. Louis Health Care System
Information provided by (Responsible Party):
Jeremiah Weinstock, St. Louis University

Tracking Information
First Submitted Date  ICMJE April 3, 2013
First Posted Date  ICMJE April 10, 2013
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE April 2013
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard Aftercare Treatment
  • 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.
    Interventions:
    • Behavioral: Motivational enhancement therapy (MET)
    • Behavioral: Contingency management
    • Behavioral: Standard Aftercare Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
147
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2013)
150
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828307
Other Study ID Numbers  ICMJE R01DA033411-01A1( U.S. NIH Grant/Contract )
23298 ( Other Identifier: Saint Louis University Institutional Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeremiah Weinstock, St. Louis University
Study Sponsor  ICMJE St. Louis University
Collaborators  ICMJE VA St. Louis Health Care System
Investigators  ICMJE
Principal Investigator: Jeremiah Weinstock, PhD St. Louis University
PRS Account St. Louis University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP