- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204879
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
Conditions
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
Collaborators
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
Additional Relevant MeSH Terms
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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