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Completed

NCT Number: NCT01832649

Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

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.

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Key information

Conditions

Cocaine Dependence Behavior Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Motor Activity Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Health Education

Behavioral

Supervised groups 2 times per week during 8 weeks.

Primary outcomes

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

    Time frame: weekly, up to 8 weeks

Secondary outcomes

  1. Mood states measured by Profile of Mood States (POMS)

    Time frame: weekly, up to 8 weeks

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

    Time frame: monthly, up to 2 months

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

    Time frame: Change from Baseline Physical Fitness at 2 months

  4. 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

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

    Time frame: Change from Baseline Cocaine Craving at 2 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2013
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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