Official Title: “Medication Development for Cocaine Dependence”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study

Study Primary Completion Date: October 2010

Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals, no medication has proven to be effective for treating cocaine dependence. Cocaine's rewarding effects are primarily a result of altering nerve pathways involving dopamine, a naturally-occurring chemical in the brain. Past research has focused on developing medications that either block dopamine or inhibit its release. However, these medications have not proven effective in treating cocaine dependence. This study will evaluate a new strategy of treating cocaine dependence by altering dopamine's functional expression. Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid (GABA), another brain chemical. Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals. The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals.

Participants will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks. Follow-up visits will occur at 2 weeks and 1, 2, and 3 months following completion of treatment, and will include evaluations of cocaine use and psychosocial functioning.

Intervention(s) in this Clinical Trial

• Drug: Topiramate
  • Topiramate up to 300 mg per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Topiramate
• Placebo Comparator: Placebo

Primary Measures

• Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine).
  • Time Frame: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)
    Safety Issue?: No

Secondary Measures

• Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment
  • Time Frame: measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment
    Safety Issue?: No

Inclusion Criteria:

• Current DSM-IV diagnosis of cocaine dependence
• Seeking treatment for cocaine dependence
• At least one positive urine drug screen, within the 2 weeks prior to study entry
• 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
• Organic brain disease
• Dementia
• Bulimia and/or anorexia nervosa
• Seizure disorders or epilepsy
• History of suicide attempts and/or current suicidal ideation, as determined by the SCID, within the 30 days prior to study entry
• Mandated by the court to obtain treatment for cocaine dependence
• Expected to relocate from the study area
• AIDS diagnosis, or a CD4 cell count less than 500 mm
• Active or history of syphilis
• Severe or life-threatening adverse reaction to any medications the year prior to study entry
• 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 pharmacotherapy with psychotropics, including antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor stimulant-type medications, within the two weeks prior to study entry
• Use of St. John's Wort, yohimbine, ginko biloba, horehound, or any other central nervous system active herbal preparations within the 2 weeks prior to study entry
• Use of any opiate substitutes (e.g., methadone, levo-alpha acetyl methadol, buprenorphine), within the month prior to study entry
• Clinically significant test results that, in the investigator's opinion, may interfere with study participation
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Bankole Johnson Principal Investigator University of Virginia  

Overall Contact: Mindy Borszich (434)243-0549 mcb3x@virginia.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00249691

Study ID Number: NIDA-17296-1

ClinicalTrials.gov Identifier: NCT00249691

Health Authority: United States: Food and Drug Administration

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