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Reinforcing Exercise in Substance Abusing Patients

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ClinicalTrials.gov Identifier: NCT01204879
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
UConn Health

Brief Summary:
This study will evaluate the efficacy of an exercise-based contingency management (CM) intervention. A total of 120 substance abusing patients in intensive outpatient treatment will be randomly assigned to one of two conditions: (a) standard care plus CM for completing goal-related activities not related to exercising (e.g., improving work, family, or transportation issues), or (b) standard care plus CM for completing exercise-related activities. Compared to those receiving goal-related CM activity contracting, it is expected that those in the exercise CM condition will participate in more physical activities and develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors, lessen depressive symptoms, and improve health indices.

Condition or disease Intervention/treatment Phase
Substance Abuse Contingency Management Exercise Behavioral: Contingency Management Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reinforcing Exercise in Substance Abusing Patients
Study Start Date : April 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CM for general activities
Standard care plus individual contingency management session for general activities
Behavioral: Contingency Management
Participants earn the chance to win prizes for the targeted behavior.
Experimental: CM for exercise-related activities
Standard care plus individual contingency management session for physical activities
Behavioral: Contingency Management
Participants earn the chance to win prizes for the targeted behavior.



Primary Outcome Measures :
  1. physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: baseline ]
  2. physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 2 ]
  3. physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 4 ]
  4. physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 6 ]
  5. physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 9 ]
  6. physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 12 ]
  7. attendance at exercise classes [ Time Frame: baseline ]
  8. attendance at exercise classes [ Time Frame: month 2 ]
  9. attendance at exercise classes [ Time Frame: month 4 ]
  10. attendance at exercise classes [ Time Frame: month 6 ]
  11. attendance at exercise classes [ Time Frame: month 9 ]
  12. attendance at exercise classes [ Time Frame: month 12 ]

Secondary Outcome Measures :
  1. longest duration of abstinence [ Time Frame: baseline ]
  2. longest duration of abstinence [ Time Frame: month 2 ]
  3. longest duration of abstinence [ Time Frame: month 4 ]
  4. longest duration of abstinence [ Time Frame: month 6 ]
  5. longest duration of abstinence [ Time Frame: month 9 ]
  6. longest duration of abstinence [ Time Frame: month 12 ]
  7. HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: baseline ]
  8. HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 2 ]
  9. HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 4 ]
  10. HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 6 ]
  11. HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 9 ]
  12. HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 12 ]
  13. psychological distress as reported on BSI questionnaire [ Time Frame: baseline ]
  14. psychological distress as reported on BSI questionnaire [ Time Frame: month 2 ]
  15. psychological distress as reported on BSI questionnaire [ Time Frame: month 4 ]
  16. psychological distress as reported on BSI questionnaire [ Time Frame: month 6 ]
  17. psychological distress as reported on BSI questionnaire [ Time Frame: month 9 ]
  18. psychological distress as reported on BSI questionnaire [ Time Frame: month 12 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-65 years
  • English speaking
  • in substance abuse treatment
  • written permission from a physician (or their designated health care professional, e.g., nurse, physicians assistant) to participate in the study and an exercise program.

Exclusion Criteria:

  • inability to comprehend the study
  • in recovery for pathological gambling
  • contraindication for exercising

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204879


Locations
United States, Connecticut
Alcohol and Drug Recovery Centers, Inc.
Hartford, Connecticut, United States, 60112
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Conncecticut Health Center

Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT01204879     History of Changes
Other Study ID Numbers: 10-010S-2
R01DA027615 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders