Completed

Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence

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What is being tested

Exercise

+ Health education

Behavioral
Who is being recruted

Behavior+3

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Last updated: April 16, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01832649
Principal SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Last updated: April 16, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersChemically-Induced DisordersMotor ActivityCocaine-Related Disorders

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Moderate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks.

Group II

Active Comparator
Health education sessions. 50 minutes per session, 2 times per week, 8 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital de la Santa Creu i Sant Pau

Barcelona, SpainOpen Hospital de la Santa Creu i Sant Pau in Google Maps
CompletedOne Study Center