Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bankole Johnson
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Topiramate

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