Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1
Cocaine-Related Disorders
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine addiction, cocaine dependence
Eligibility Criteria
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
Sites / Locations
- UVA CARE
- UVA CARE Richmond
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Topiramate
Placebo