Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

Not Applicable

Completed

• Conditions: Cocaine Dependence
• Interventions: Behavioral: Exercise; Behavioral: Health education

• Registration Number: NCT01832649
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-12
• Last Update Submitted: 2013-04-12
• Study First Posted: 2013-04-16
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Moderate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks.
Health education	Health education	Health education sessions. 50 minutes per session, 2 times per week, 8 weeks.

Primary Outcome Measures

Name	Time	Method
Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)	weekly, up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain