Exercise as a Behavioral Treatment for Cocaine Dependence

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.

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.