Exercise as a Behavioral Treatment for Cocaine Dependence
3 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 20, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 27, 2015
May 1, 2012
2.8 years
February 20, 2012
January 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
The effects of exercise on changes in drug use measures and in self-reported craving for cocaine and/or nicotine
4 weeks
The effects of exercise on Brain Derived Neurotrophic Factor (BDNF) in blood samples
4 weeks
The effects of exercise on changes in drug use measures
4 weeks
Study Arms (3)
Sitting
ACTIVE COMPARATORSitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).
Running
ACTIVE COMPARATORExercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Walking
ACTIVE COMPARATORExercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- In order to participate in the study, participants must:
- \. Be English-speaking volunteers between 21-55 years of age
- \. Be cocaine-dependent and nicotine-dependent (\>10 cigarettes/day and FTND \>4)
- \. Be seeking treatment for cocaine dependence
- \. Have vital signs as follows: resting pulse between 50-90 bpm, supine blood pressures between 85-150 mmHg systolic and 45-90 mmHg diastolic
- \. Have a breathalyzer test indicating an undetectable blood alcohol level
You may not qualify if:
- Potential participants will be excluded if any of the following apply:
- \. 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
- \. Meet DSM-IV criteria for abuse or dependence on other drugs, except for cocaine or nicotine
- \. Have any of the conditions defined by the American College of Sports Medicine (2006) as "absolute contraindications to exercise testing"
- \. Have evidence of clinically significant heart disease or hypertension
- \. Have evidence of clinically significant or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
- \. Be pregnant or nursing. All females must provide a negative pregnancy urine test
- \. Currently use alpha or beta agonists, theophylline, or other sympathomimetics
- \. Currently engaged in an exercise regimen of similar intensity as those planned for investigation
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard De La Garza, II, PhD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 20, 2012
First Posted
May 18, 2012
Study Start
September 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
January 27, 2015
Record last verified: 2012-05