Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

NCT01832649 | Completed DMC

• 1 other identifier: IIBSP-PEF-2011-98
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Dependence

Keywords

Exercise; Cocaine dependence

Outcome Measures

Primary Outcomes (1)

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

  weekly, up to 8 weeks

Secondary Outcomes (5)

• Mood states measured by Profile of Mood States (POMS)

  weekly, up to 8 weeks

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

  monthly, up to 2 months

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

  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

  weekly, up to 8 weeks

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

  Change from Baseline Cocaine Craving at 2 months

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Health education

ACTIVE COMPARATOR

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

Behavioral: Health education

Interventions

Exercise BEHAVIORAL

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

Exercise

Health education BEHAVIORAL

Supervised groups 2 times per week during 8 weeks.

Health education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV diagnosis of cocaine dependence as primary disorder
• age between 18 and 60 years
• current psychosocial cocaine treatment

You may not qualify if:

• medical problems that contraindicate the participation in an exercise program
• family history of sudden death and/or early death due to cardiovascular reasons

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nuria Siñol Llosa

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 16, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

ES (1)