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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01204879
Other study ID # 10-010S-2
Secondary ID R01DA027615
Status Completed
Phase N/A
First received August 9, 2010
Last updated June 22, 2017
Start date April 2010
Est. completion date July 2015

Study information

Verified date December 2016
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Contingency Management
Participants earn the chance to win prizes for the targeted behavior.

Locations

Country Name City State
United States Alcohol and Drug Recovery Centers, Inc. Hartford Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) baseline
Primary physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) month 2
Primary physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) month 4
Primary physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) month 6
Primary physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) month 9
Primary physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures) month 12
Primary attendance at exercise classes baseline
Primary attendance at exercise classes month 2
Primary attendance at exercise classes month 4
Primary attendance at exercise classes month 6
Primary attendance at exercise classes month 9
Primary attendance at exercise classes month 12
Secondary longest duration of abstinence baseline
Secondary longest duration of abstinence month 2
Secondary longest duration of abstinence month 4
Secondary longest duration of abstinence month 6
Secondary longest duration of abstinence month 9
Secondary longest duration of abstinence month 12
Secondary HIV risk behaviors as reported on HRBS questionnaire baseline
Secondary HIV risk behaviors as reported on HRBS questionnaire month 2
Secondary HIV risk behaviors as reported on HRBS questionnaire month 4
Secondary HIV risk behaviors as reported on HRBS questionnaire month 6
Secondary HIV risk behaviors as reported on HRBS questionnaire month 9
Secondary HIV risk behaviors as reported on HRBS questionnaire month 12
Secondary psychological distress as reported on BSI questionnaire baseline
Secondary psychological distress as reported on BSI questionnaire month 2
Secondary psychological distress as reported on BSI questionnaire month 4
Secondary psychological distress as reported on BSI questionnaire month 6
Secondary psychological distress as reported on BSI questionnaire month 9
Secondary psychological distress as reported on BSI questionnaire month 12
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