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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA030722 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitting | Active Comparator | Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks). |
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| Running | Active Comparator | Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. |
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| Walking | Active Comparator | Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitting | Behavioral | Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
In order to participate in the study, participants must:
Exclusion Criteria:
Potential participants will be excluded if any of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Richard De La Garza, II, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey Veterans Affairs Medical Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077708 | Sitting Position |
| D012420 | Running |
| D016138 | Walking |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008124 | Locomotion |
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| Running | Behavioral | Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. |
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| Walking | Behavioral | Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks. |
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| 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). | 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. | 4 weeks |
| D009068 | Movement |
| D015444 | Exercise |
| D009043 | Motor Activity |