Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cocaine Dependence

Interventions

ExerciseBEHAVIORAL

Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.

Health educationBEHAVIORAL

Supervised groups 2 times per week during 8 weeks.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)

Time frame: weekly, up to 8 weeks

Secondary Outcomes

Mood states measured by Profile of Mood States (POMS)

Time frame: weekly, up to 8 weeks

Quality of life measured by 36-item Short-Form Survey (SF-36)

Time frame: monthly, up to 2 months

Change in Physical fitness (BMI, functional capacity and strength)

Time frame: 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

Time frame: weekly, up to 8 weeks

Change in cocaine craving measured by means of visual analogue scale (VAS)

Time frame: Change from Baseline Cocaine Craving at 2 months

Data from ClinicalTrials.gov

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