Reinforcing Exercise in Substance Abusing Patients

This study is currently recruiting participants.

Verified January 2013 by University of Connecticut Health Center

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

University of Connecticut Health Center

ClinicalTrials.gov Identifier:

NCT01204879

First received: August 9, 2010

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Exercise and Physical Fitness HIV/AIDS

U.S. FDA Resources

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

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

National Institute on Drug Abuse (NIDA)

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:	January 15, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013

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