Back to resultsExercise as a Behavioral Treatment for Cocaine Dependence
Primary Purpose
Cocaine Dependence, Cocaine Addiction, Cocaine Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sitting
Running
Walking
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, Exercise
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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.
Sites / Locations
- Michael E. DeBakey Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sitting
Running
Walking
Arm Description
Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).
Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
Full Information
NCT ID
NCT01601743
First Posted
February 20, 2012
Last Updated
January 26, 2015
Sponsor
Baylor College of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01601743
Brief Title
Exercise as a Behavioral Treatment for Cocaine Dependence
Official Title
Exercise as a Behavioral Treatment for Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Substance Abuse
Keywords
Cocaine, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitting
Arm Type
Active Comparator
Arm Description
Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).
Arm Title
Running
Arm Type
Active Comparator
Arm Description
Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Arm Title
Walking
Arm Type
Active Comparator
Arm Description
Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Intervention Type
Behavioral
Intervention Name(s)
Sitting
Intervention Description
Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).
Intervention Type
Behavioral
Intervention Name(s)
Running
Intervention Description
Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Primary Outcome Measure Information:
Title
The effects of exercise on cardiovascular and basic fitness measures
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The effects of exercise on changes in drug use measures and in self-reported craving for cocaine and/or nicotine
Description
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.
Time Frame
4 weeks
Title
The effects of exercise on Brain Derived Neurotrophic Factor (BDNF) in blood samples
Description
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).
Time Frame
4 weeks
Title
The effects of exercise on changes in drug use measures
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard De La Garza, II, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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