Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

Cocaine Dependence Clinical Trial

Official title:

Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832649
• Other study ID #: IIBSP-PEF-2011-98
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: April 12, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Behavioral:
• Exercise
Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.
• Health education
Supervised groups 2 times per week during 8 weeks.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)		weekly, up to 8 weeks	No
Secondary	Mood states measured by Profile of Mood States (POMS)		weekly, up to 8 weeks	No
Secondary	Quality of life measured by 36-item Short-Form Survey (SF-36)		monthly, up to 2 months	No
Secondary	Change in Physical fitness (BMI, functional capacity and strength)		Change from Baseline Physical Fitness at 2 months	No
Secondary	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	No
Secondary	Change in cocaine craving measured by means of visual analogue scale (VAS)		Change from Baseline Cocaine Craving at 2 months	No