Cocaine Dependence
Conditions
Keywords
Exercise, Cocaine dependence
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.
Detailed 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.
Interventions
BEHAVIORALExercise
Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.
BEHAVIORALHealth education
Supervised groups 2 times per week during 8 weeks.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss) | weekly, up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in cocaine craving measured by means of visual analogue scale (VAS) | Change from Baseline Cocaine Craving 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 |
| 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 |
Countries
Spain
Outcome results
None listed