Although a great amount of research has been conducted to resolve cocaine dependence, an
effective treatment has yet to be discovered. Topiramate is a drug that was found to be
useful in treating alcohol dependence. The purpose of this study is to determine the
effectiveness of topiramate in treating cocaine dependent individuals.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Current DSM-IV diagnosis of cocaine dependence
- Good physical health as determined by a complete physical examination, an EKG within
normal limits, and laboratory screening tests within acceptable parameters
- Seeking treatment for cocaine dependence
- At least one positive urine drug screen for cocaine at screen or baseline prior to
randomization
- If female, a negative pregnancy test prior to study entry
- Agrees to use an effective method of contraception for the duration of the study
- Reads and writes English
- Willing to participate in behavioral treatment for cocaine dependence
Exclusion Criteria:
- Current DSM-IV diagnosis of dependence on any psychoactive substance other than
cocaine, alcohol, nicotine, caffeine, or marijuana
- Physiological dependence on alcohol and requires medical detoxification
- Neurological or psychiatric disorders
- Any Axis 1 disorder that warrants treatment or would preclude safe participation
- Organic brain disease
- Dementia
- Bulimia and/or anorexia nervosa
- Seizure disorders or epilepsy
- Any disorder which would require ongoing treatment or which would make study agent
compliance difficult
- History of suicide attempts and/or current suicidal ideation, as determined by the
SCID, within the 30 days prior to screening
- Serious medical illnesses
- Mandated by the court to obtain treatment for cocaine dependence
- Expected to relocate from the study area
- AIDS diagnosis
- HIV with a CD4 positive T cell count less than 500 mm
- Any subjects on any pharmacotherapy for the treatment of AIDS or HIV will be excluded
- Active syphilis that has not been treated, or refused treatment for syphilis
- Severe or life-threatening adverse reactions to medications (including topiramate) in
the past or during this clinical trial
- Currently receiving active treatment with topiramate
- Use of a drug with known potential for toxicity to a major organ system (e. g.,
isoniazid, methotrexate), within 30 days prior to study entry
- Pregnant or breastfeeding
- Concurrent regular use of psychotropics, including but not limited to
antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor
stimulant-type medications, St. John's Wort, yohimbine, ginko biloba, horehound, or
any other central nervous system active herbal preparations
- Use of any opiate substitutes (e. g., methadone, levo-alpha acetyl methadol,
buprenorphine), within the month prior to screening
- Clinically significant test results that, in the investigator's opinion, require
immediate or urgent treatment
- Fever of unknown origin or neuroleptic malignant syndrome
- Serious medical co-morbidity requiring medical intervention or close supervision
- Received inpatient or outpatient treatment for cocaine dependence within the 4 weeks
prior to study entry
- Past participation in a clinical trial utilizing topiramate
- Treatment with electroconvulsive therapy within the 3 months prior to study entry
- Member of the same household of an individual enrolled in the present study