Reinforcing Exercise in Substance Abusing Patients

June 22, 2017 updated by: UConn Health
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • Hartford, Connecticut, United States, 60112
        • Alcohol and Drug Recovery Centers, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CM for general activities
Standard care plus individual contingency management session for general activities
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
Participants earn the chance to win prizes for the targeted behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame: baseline
baseline
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame: month 2
month 2
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame: month 4
month 4
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame: month 6
month 6
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame: month 9
month 9
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame: month 12
month 12
attendance at exercise classes
Time Frame: baseline
baseline
attendance at exercise classes
Time Frame: month 2
month 2
attendance at exercise classes
Time Frame: month 4
month 4
attendance at exercise classes
Time Frame: month 6
month 6
attendance at exercise classes
Time Frame: month 9
month 9
attendance at exercise classes
Time Frame: month 12
month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
longest duration of abstinence
Time Frame: baseline
baseline
longest duration of abstinence
Time Frame: month 2
month 2
longest duration of abstinence
Time Frame: month 4
month 4
longest duration of abstinence
Time Frame: month 6
month 6
longest duration of abstinence
Time Frame: month 9
month 9
longest duration of abstinence
Time Frame: month 12
month 12
HIV risk behaviors as reported on HRBS questionnaire
Time Frame: baseline
baseline
HIV risk behaviors as reported on HRBS questionnaire
Time Frame: month 2
month 2
HIV risk behaviors as reported on HRBS questionnaire
Time Frame: month 4
month 4
HIV risk behaviors as reported on HRBS questionnaire
Time Frame: month 6
month 6
HIV risk behaviors as reported on HRBS questionnaire
Time Frame: month 9
month 9
HIV risk behaviors as reported on HRBS questionnaire
Time Frame: month 12
month 12
psychological distress as reported on BSI questionnaire
Time Frame: baseline
baseline
psychological distress as reported on BSI questionnaire
Time Frame: month 2
month 2
psychological distress as reported on BSI questionnaire
Time Frame: month 4
month 4
psychological distress as reported on BSI questionnaire
Time Frame: month 6
month 6
psychological distress as reported on BSI questionnaire
Time Frame: month 9
month 9
psychological distress as reported on BSI questionnaire
Time Frame: month 12
month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Nancy M Petry, Ph.D., University of Conncecticut Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 10-010S-2
  • R01DA027615 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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