NCT01204879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 26, 2017

Status Verified

December 1, 2016

Enrollment Period

5.3 years

First QC Date

August 9, 2010

Last Update Submit

June 22, 2017

Conditions

Substance AbuseContingency ManagementExercise

Outcome Measures

Primary Outcomes (12)

  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)

    baseline

  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)

    month 2

  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)

    month 4

  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)

    month 6

  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)

    month 9

  • physical activity participation and functioning measured by the PAQ (Kcal/wk expenditures)

    month 12

  • attendance at exercise classes

    baseline

  • attendance at exercise classes

    month 2

  • attendance at exercise classes

    month 4

  • attendance at exercise classes

    month 6

  • attendance at exercise classes

    month 9

  • attendance at exercise classes

    month 12

Secondary Outcomes (18)

  • longest duration of abstinence

    baseline

  • longest duration of abstinence

    month 2

  • longest duration of abstinence

    month 4

  • longest duration of abstinence

    month 6

  • longest duration of abstinence

    month 9

  • +13 more secondary outcomes

Study Arms (2)

CM for general activities

ACTIVE COMPARATOR

Standard care plus individual contingency management session for general activities

Behavioral: Contingency Management

CM for exercise-related activities

EXPERIMENTAL

Standard care plus individual contingency management session for physical activities

Behavioral: Contingency Management

Interventions

Contingency ManagementBEHAVIORAL

Participants earn the chance to win prizes for the targeted behavior.

CM for exercise-related activitiesCM for general activities

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • inability to comprehend the study
  • in recovery for pathological gambling
  • contraindication for exercising

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcohol and Drug Recovery Centers, Inc.

Hartford, Connecticut, 60112, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersMotor Activity

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Nancy M Petry, Ph.D.

    University of Conncecticut Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2010

First Posted

September 17, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 26, 2017

Record last verified: 2016-12

Locations

US(1)