search
Back to results

Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Health education
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Exercise, Cocaine dependence

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Health education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mood states measured by Profile of Mood States (POMS)
Quality of life measured by 36-item Short-Form Survey (SF-36)
Change in Physical fitness (BMI, functional capacity and strength)
Percent days abstinent defined as the ratio between the number of negative cocaine urine test and the number of realised cocaine urine test
Change in cocaine craving measured by means of visual analogue scale (VAS)

Full Information

First Posted
April 5, 2013
Last Updated
April 12, 2013
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
search

1. Study Identification

Unique Protocol Identification Number
NCT01832649
Brief Title
Exercise as an Adjunctive Treatment for Cocaine Dependent Patients
Official Title
Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Exercise, Cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Moderate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks.
Arm Title
Health education
Arm Type
Active Comparator
Arm Description
Health education sessions. 50 minutes per session, 2 times per week, 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Supervised groups 2 times per week during 8 weeks.
Primary Outcome Measure Information:
Title
Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)
Time Frame
weekly, up to 8 weeks
Secondary Outcome Measure Information:
Title
Mood states measured by Profile of Mood States (POMS)
Time Frame
weekly, up to 8 weeks
Title
Quality of life measured by 36-item Short-Form Survey (SF-36)
Time Frame
monthly, up to 2 months
Title
Change in Physical fitness (BMI, functional capacity and strength)
Time Frame
Change from Baseline Physical Fitness at 2 months
Title
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
Title
Change in cocaine craving measured by means of visual analogue scale (VAS)
Time Frame
Change from Baseline Cocaine Craving at 2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria Siñol Llosa
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Exercise as an Adjunctive Treatment for Cocaine Dependent Patients

We'll reach out to this number within 24 hrs