Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

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