Cocaine DependenceNCT01832649
Exercise as an Adjunctive Treatment for Cocaine Dependent Patients
A study testing Exercise and Health education in people with Cocaine Dependence, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Exercise and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of cocaine dependence as primary disorder
- age between 18 and 60 years
- current psychosocial cocaine treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence
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.
Read the 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.
- Conditions
- Cocaine Dependence
- Being tested
- Exercise, Health education
- Keywords
- Exercise, Cocaine dependence
- Medical subject headings
- Cocaine-Related Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.
Health educationBehavioural
Supervised groups 2 times per week during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Moderate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks. Receives: Behavioral: Exercise |
| Health education | Active comparator | Health education sessions. 50 minutes per session, 2 times per week, 8 weeks. Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)
Measured: weekly, up to 8 weeks
Secondary outcomes (5)
Mood states measured by Profile of Mood States (POMS)
Measured: weekly, up to 8 weeks
Quality of life measured by 36-item Short-Form Survey (SF-36)
Measured: monthly, up to 2 months
Change in Physical fitness (BMI, functional capacity and strength)
Measured: 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
Measured: weekly, up to 8 weeks
Change in cocaine craving measured by means of visual analogue scale (VAS)
Measured: Change from Baseline Cocaine Craving at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuria Siñol Llosa, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832649
- Sponsor's protocol ID
- IIBSP-PEF-2011-98
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exercise Program in the Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01832649
- Acronym / sponsor ID
- IIBSP-PEF-2011-98
- Conditions
- Cocaine Dependence
- Keywords
- Exercise, Cocaine dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseModerate-vigorous intensity strength exercise. 50 minutes per session, 2 times per week, 8 weeks. |
| Health education | Active comparator | Behavioral: Health educationHealth education sessions. 50 minutes per session, 2 times per week, 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DSM-IV diagnosis of cocaine dependence as primary disorder
- age between 18 and 60 years
- current psychosocial cocaine treatment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSupervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks. | Behavioural | Exercise |
| Health educationSupervised groups 2 times per week during 8 weeks. | Behavioural | Health education |
Primary outcome
Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss)
Time frame: weekly, up to 8 weeks
5 secondary outcomes
Mood states measured by Profile of Mood States (POMS)
Time frame: weekly, up to 8 weeks
Quality of life measured by 36-item Short-Form Survey (SF-36)
Time frame: monthly, up to 2 months
Change in Physical fitness (BMI, functional capacity and strength)
Time frame: 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
Time frame: weekly, up to 8 weeks
Change in cocaine craving measured by means of visual analogue scale (VAS)
Time frame: Change from Baseline Cocaine Craving at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuria Siñol Llosa principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Health education in people with Cocaine Dependence, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine craving measured by means of a 5-item craving questionnaire (Roger D. Weiss) (time frame: weekly, up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2013.