Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

NCT ID: NCT01832649

Last Updated: 2013-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

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.

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Health education

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

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

Supervised groups 2 times per week during 8 weeks.

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Health education

Supervised groups 2 times per week during 8 weeks.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuria Siñol Llosa

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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IIBSP-PEF-2011-98

Identifier Type: -

Identifier Source: org_study_id

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