Cocaine DependenceNCT01601743
Exercise as a Behavioral Treatment for Cocaine Dependence
A study testing Sitting, Running and Walking in people with Cocaine Dependence and Cocaine Addiction, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of exercise on cocaine use, fitness, and cravings for cocaine and nicotine. This study is part of an effort to develop treatments for cocaine abuse. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse
- What is being tested?
- Sitting, Running and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2014
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In order to participate in the study, participants must:
- 1. Be English-speaking volunteers between 21-55 years of age
- 2. Be cocaine-dependent and nicotine-dependent (>10 cigarettes/day and FTND >4)
- 3. Be seeking treatment for cocaine dependence
- 4. Have vital signs as follows: resting pulse between 50-90 bpm, supine blood pressures between 85-150 mmHg systolic and 45-90 mmHg diastolic
- 5. Have a breathalyzer test indicating an undetectable blood alcohol level
- 6. Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the PI. Most relevant, assessments will include the participants' general health and suitability for inclusion in a rigorous exercise program.
Who cannot join
- Potential participants will be excluded if any of the following apply:
- 1. Have neurological or psychiatric disorders, as assessed by MINI, such as: a. current major depression; b. lifetime history of schizophrenia, other psychotic illness, or bipolar illness; c. current organic brain disease or dementia assessed by clinical interview; d. current psychiatric disorder as assessed by the MINI including history of suicide attempts within the past three months and/or current suicidal ideation/plan
- 2. Meet DSM-IV criteria for abuse or dependence on other drugs, except for cocaine or nicotine
- 3. Have any of the conditions defined by the American College of Sports Medicine (2006) as "absolute contraindications to exercise testing"
- 4. Have evidence of clinically significant heart disease or hypertension
- 5. Have evidence of clinically significant or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
Show all 10Show fewer
- 6. Be pregnant or nursing. All females must provide a negative pregnancy urine test
- 7. Currently use alpha or beta agonists, theophylline, or other sympathomimetics
- 8. Currently engaged in an exercise regimen of similar intensity as those planned for investigation
- 9. Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the study physician would preclude safe and/or successful completion of study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
The purpose of this study is to test the effects of exercise on cocaine use, fitness, and cravings for cocaine and nicotine. This study is part of an effort to develop treatments for cocaine abuse.
Read the detailed description
This proposal represents an important research effort with considerable public health significance in that it will provide detailed behavioral and physiological data for a non-pharmacological intervention to treat stimulant addiction. Regular exercise is known to promote better mental and physical health, however the effects of exercise on cocaine use and craving in cocaine-dependent individuals has not been previously assessed. The Specific Aims include: 1) To evaluate the effects of regular exercise (running and walking) versus placebo (sitting) on basic fitness measures; 2) To evaluate the effects of exercise on objective and subjective measures of cocaine and nicotine use and craving. Participants will also receive a total of 12 sessions of a standardized series of computerized cognitive behavioral therapy (CCBT) modules, which are specifically designed for the treatment of cocaine addiction.
- Conditions
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Substance Abuse
- Being tested
- Sitting, Running, Walking
- Keywords
- Cocaine, Exercise
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SittingBehavioural
Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).
RunningBehavioural
Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
WalkingBehavioural
Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sitting | Active comparator | Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks). Receives: Behavioral: Sitting |
| Running | Active comparator | Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. Receives: Behavioral: Running |
| Walking | Active comparator | Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. Receives: Behavioral: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of exercise on cardiovascular and basic fitness measures
Before and after each exercise session, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on exercise relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
Measured: 4 weeks
Secondary outcomes (3)
The effects of exercise on changes in drug use measures and in self-reported craving for cocaine and/or nicotine
The effects of exercise (running vs. walking 30 min per session, 3 times per week, over 4 consecutive weeks) versus placebo (sitting for the same period of time and duration) on self-reports of craving for cocaine/nicotine will be measured by the Brief Substance Craving Scale (BSCS), Wisconsin Smoking Withdrawal Scale (WSWS), and the Questionnaire of Smoking Urges (QSU-Brief) throughout the 4-week study period and at 2 follow-up visits.
Measured: 4 weeks
The effects of exercise on Brain Derived Neurotrophic Factor (BDNF) in blood samples
The effects of exercise versus placebo on changes in BDNF will be measured, since exercise has been shown to increase BDNF and neurogenesis in the hippocampus. Approximately 2 mls of blood will be taken for BDNF analysis at six timepointss during and after the study: 1) On day 1 prior to randomization 2) once weekly on Fridays - i.e., 4 measures at end of treatment at Week 1, 2, 3, and 4. Samples will be taken 20 minutes before participants run, walk or sit. 3) at follow up visit (39 weeks or 52 weeks).
Measured: 4 weeks
The effects of exercise on changes in drug use measures
The effects of exercise (running vs. walking 30 min per session, 3 times per week, over 4 consecutive weeks) versus placebo (sitting for the same period of time and duration) on changes in drug use will be assessed by measuring urine toxicology and salivary nicotine and cotinine throughout the 4-week study and at 2 follow-up visits.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2014
- Study completionJul 2014
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 Baylor College of MedicineThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard De La Garza, Baylor College of Medicine
- Investigators
- Richard De La Garza, II, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601743
- Sponsor's protocol ID
- H-27380
- Other IDs
- 1R21DA030722, DPMC
- Status last verified
- May 2012
- First submitted
- 20 Feb 2012
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as a Behavioral Treatment for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01601743
- Acronym / sponsor ID
- H-27380
- Conditions
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Substance Abuse
- Keywords
- Cocaine, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 May 2012 (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 test the effects of exercise on cocaine use, fitness, and cravings for cocaine and nicotine. This study is part of an effort to develop treatments for cocaine abuse.
Detailed description
This proposal represents an important research effort with considerable public health significance in that it will provide detailed behavioral and physiological data for a non-pharmacological intervention to treat stimulant addiction. Regular exercise is known to promote better mental and physical health, however the effects of exercise on cocaine use and craving in cocaine-dependent individuals has not been previously assessed. The Specific Aims include: 1) To evaluate the effects of regular exercise (running and walking) versus placebo (sitting) on basic fitness measures; 2) To evaluate the effects of exercise on objective and subjective measures of cocaine and nicotine use and craving. Participants will also receive a total of 12 sessions of a standardized series of computerized cognitive behavioral therapy (CCBT) modules, which are specifically designed for the treatment of cocaine addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitting | Active comparator | Behavioral: SittingSitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks). |
| Running | Active comparator | Behavioral: RunningExercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. |
| Walking | Active comparator | Behavioral: WalkingExercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Be English-speaking volunteers between 21-55 years of age
- 2. Be cocaine-dependent and nicotine-dependent (>10 cigarettes/day and FTND >4)
- 3. Be seeking treatment for cocaine dependence
- 4. Have vital signs as follows: resting pulse between 50-90 bpm, supine blood pressures between 85-150 mmHg systolic and 45-90 mmHg diastolic
- 5. Have a breathalyzer test indicating an undetectable blood alcohol level
Key exclusion criteria (10 listed)
- 1. Have neurological or psychiatric disorders, as assessed by MINI, such as: a. current major depression; b. lifetime history of schizophrenia, other psychotic illness, or bipolar illness; c. current organic brain disease or dementia assessed by clinical interview; d. current psychiatric disorder as assessed by the MINI including history of suicide attempts within the past three months and/or current suicidal ideation/plan
- 2. Meet DSM-IV criteria for abuse or dependence on other drugs, except for cocaine or nicotine
- 3. Have any of the conditions defined by the American College of Sports Medicine (2006) as "absolute contraindications to exercise testing"
- 4. Have evidence of clinically significant heart disease or hypertension
- 5. Have evidence of clinically significant or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
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 |
|---|---|---|
| SittingSitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks). | Behavioural | Sitting |
| RunningExercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. | Behavioural | Running |
| WalkingExercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. | Behavioural | Walking |
Primary outcome
The effects of exercise on cardiovascular and basic fitness measures
Time frame: 4 weeks
Before and after each exercise session, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on exercise relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
3 secondary outcomes
The effects of exercise on changes in drug use measures and in self-reported craving for cocaine and/or nicotine
Time frame: 4 weeks
The effects of exercise on Brain Derived Neurotrophic Factor (BDNF) in blood samples
Time frame: 4 weeks
The effects of exercise on changes in drug use measures
Time frame: 4 weeks
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 27 Jan 2015.
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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.
Richard De La Garza, II, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting, Running and Walking in people with Cocaine Dependence and Cocaine Addiction, run by Baylor College of Medicine at 1 site in United States.
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 7 inclusion and 10 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 27 Jan 2015. 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 United States. 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?
The effects of exercise on cardiovascular and basic fitness measures (time frame: 4 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 27 Jan 2015.