Reinforcing Exercise in Substance Abusing Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01204879
First received: August 9, 2010
Last updated: February 24, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Substance Abuse
Contingency Management
Exercise
Behavioral: Contingency Management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reinforcing Exercise in Substance Abusing Patients

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 2 ] [ Designated as safety issue: No ]
  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 9 ] [ Designated as safety issue: No ]
  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • attendance at exercise classes [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • attendance at exercise classes [ Time Frame: month 2 ] [ Designated as safety issue: No ]
  • attendance at exercise classes [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • attendance at exercise classes [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • attendance at exercise classes [ Time Frame: month 9 ] [ Designated as safety issue: No ]
  • attendance at exercise classes [ Time Frame: month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • longest duration of abstinence [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • longest duration of abstinence [ Time Frame: month 2 ] [ Designated as safety issue: No ]
  • longest duration of abstinence [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • longest duration of abstinence [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • longest duration of abstinence [ Time Frame: month 9 ] [ Designated as safety issue: No ]
  • longest duration of abstinence [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 2 ] [ Designated as safety issue: No ]
  • HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 9 ] [ Designated as safety issue: No ]
  • HIV risk behaviors as reported on HRBS questionnaire [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • psychological distress as reported on BSI questionnaire [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • psychological distress as reported on BSI questionnaire [ Time Frame: month 2 ] [ Designated as safety issue: No ]
  • psychological distress as reported on BSI questionnaire [ Time Frame: month 4 ] [ Designated as safety issue: No ]
  • psychological distress as reported on BSI questionnaire [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • psychological distress as reported on BSI questionnaire [ Time Frame: month 9 ] [ Designated as safety issue: No ]
  • psychological distress as reported on BSI questionnaire [ Time Frame: month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204879

Contacts
Contact: Ellen M Ciesielski, B.A. 860.679.4556 eciesielski@uchc.edu

Locations
United States, Connecticut
Alcohol and Drug Recovery Centers, Inc. Recruiting
Hartford, Connecticut, United States, 60112
Contact: Ellen M Ciesielski, B.A.    860-679-4556    eciesielski@uchc.edu   
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Conncecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01204879     History of Changes
Other Study ID Numbers: 10-010S-2, R01DA027615
Study First Received: August 9, 2010
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014