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Reinforcing Exercise in Substance Abusing Patients

Primary Purpose

Substance Abuse, Contingency Management, Exercise

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcohol and Drug Recovery Centers, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CM for general activities

CM for exercise-related activities

Arm Description

Standard care plus individual contingency management session for general activities

Standard care plus individual contingency management session for physical activities

Outcomes

Primary Outcome Measures

physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
attendance at exercise classes
attendance at exercise classes
attendance at exercise classes
attendance at exercise classes
attendance at exercise classes
attendance at exercise classes

Secondary Outcome Measures

longest duration of abstinence
longest duration of abstinence
longest duration of abstinence
longest duration of abstinence
longest duration of abstinence
longest duration of abstinence
HIV risk behaviors as reported on HRBS questionnaire
HIV risk behaviors as reported on HRBS questionnaire
HIV risk behaviors as reported on HRBS questionnaire
HIV risk behaviors as reported on HRBS questionnaire
HIV risk behaviors as reported on HRBS questionnaire
HIV risk behaviors as reported on HRBS questionnaire
psychological distress as reported on BSI questionnaire
psychological distress as reported on BSI questionnaire
psychological distress as reported on BSI questionnaire
psychological distress as reported on BSI questionnaire
psychological distress as reported on BSI questionnaire
psychological distress as reported on BSI questionnaire

Full Information

First Posted
August 9, 2010
Last Updated
June 22, 2017
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01204879
Brief Title
Reinforcing Exercise in Substance Abusing Patients
Official Title
Reinforcing Exercise in Substance Abusing Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Contingency Management, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CM for general activities
Arm Type
Active Comparator
Arm Description
Standard care plus individual contingency management session for general activities
Arm Title
CM for exercise-related activities
Arm Type
Experimental
Arm Description
Standard care plus individual contingency management session for physical activities
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants earn the chance to win prizes for the targeted behavior.
Primary Outcome Measure Information:
Title
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame
baseline
Title
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame
month 2
Title
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame
month 4
Title
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame
month 6
Title
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame
month 9
Title
physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)
Time Frame
month 12
Title
attendance at exercise classes
Time Frame
baseline
Title
attendance at exercise classes
Time Frame
month 2
Title
attendance at exercise classes
Time Frame
month 4
Title
attendance at exercise classes
Time Frame
month 6
Title
attendance at exercise classes
Time Frame
month 9
Title
attendance at exercise classes
Time Frame
month 12
Secondary Outcome Measure Information:
Title
longest duration of abstinence
Time Frame
baseline
Title
longest duration of abstinence
Time Frame
month 2
Title
longest duration of abstinence
Time Frame
month 4
Title
longest duration of abstinence
Time Frame
month 6
Title
longest duration of abstinence
Time Frame
month 9
Title
longest duration of abstinence
Time Frame
month 12
Title
HIV risk behaviors as reported on HRBS questionnaire
Time Frame
baseline
Title
HIV risk behaviors as reported on HRBS questionnaire
Time Frame
month 2
Title
HIV risk behaviors as reported on HRBS questionnaire
Time Frame
month 4
Title
HIV risk behaviors as reported on HRBS questionnaire
Time Frame
month 6
Title
HIV risk behaviors as reported on HRBS questionnaire
Time Frame
month 9
Title
HIV risk behaviors as reported on HRBS questionnaire
Time Frame
month 12
Title
psychological distress as reported on BSI questionnaire
Time Frame
baseline
Title
psychological distress as reported on BSI questionnaire
Time Frame
month 2
Title
psychological distress as reported on BSI questionnaire
Time Frame
month 4
Title
psychological distress as reported on BSI questionnaire
Time Frame
month 6
Title
psychological distress as reported on BSI questionnaire
Time Frame
month 9
Title
psychological distress as reported on BSI questionnaire
Time Frame
month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Petry, Ph.D.
Organizational Affiliation
University of Conncecticut Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alcohol and Drug Recovery Centers, Inc.
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
60112
Country
United States

12. IPD Sharing Statement

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Reinforcing Exercise in Substance Abusing Patients

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