Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Cocaine-Related Disorders

In brief

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.

Key facts

Study ID

NCT00249691

Run by

Bankole Johnson

People needed

180

Starts

2005-10-01

Expected to finish

2012-10-01

Last updated by the study team

2012-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UVA CARE — Charlottesville, Virginia, United States
• UVA CARE Richmond — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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