Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if exercise added to usual treatment improves cocaine dependence treatment. The primary objective of this study is to investigate if exercise can facilitate cocaine craving reduction. The secondary aims are to evaluate if exercise can reduce negative mood states, improve quality of life and facilitate abstinence of cocaine.

Detailed Description
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This study is designed as two-groups, randomized controlled trial to evaluate the effectiveness of an 8-week exercise program added to usual treatment compared with a health education program in 20 cocaine dependent patients. These participants will be randomized to one of the following two groups: a) exercise group: supervised moderate-vigorous exercise in group based on strength and calisthenics exercises, b) control group: supervised health education in group. All participants must have DSM-IV diagnosis of cocaine dependence as the primary disorder and must be in treatment.

Official Title
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Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of cocaine dependence as primary disorder age between 18 and 60 years current psychosocial cocaine treatment Exclusion Criteria: medical problems that contraindicate the participation in an exercise program family history of sudden death and/or early death due to cardiovascular reasons current inclusion in a regular exercise program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Moderate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks. | Behavioral: Exercise<br>* Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.<br>|
| Active Comparator: Health education<br>Health education sessions. 50 minutes per session, 2 times per week, 8 weeks. | Behavioral: Health education<br>* Supervised groups 2 times per week during 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss) |  | weekly, up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood states measured by Profile of Mood States (POMS) |  | weekly, up to 8 weeks | 
| Quality of life measured by 36-item Short-Form Survey (SF-36) |  | monthly, up to 2 months | 
| Change in Physical fitness (BMI, functional capacity and strength) |  | Change from Baseline Physical Fitness at 2 months | 
| Percent days abstinent defined as the ratio between the number of negative cocaine urine test and the number of realised cocaine urine test |  | weekly, up to 8 weeks | 
| Change in cocaine craving measured by means of visual analogue scale (VAS) |  | Change from Baseline Cocaine Craving at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Cocaine dependence