Official Title: “Clinical Trial of Topiramate for Cocaine Addiction”

This is an outpatient clinical trial of topiramate for addressing cocaine dependence and reduction of cocaine associated behaviors in opiate dependent drug users maintained on methadone treatment.

The study aims to answer whether topiramate 1)is safe and acceptable to methadone patients; 2)reduces cocaine use; 3) helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive performance

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2011

Intervention(s) in this Clinical Trial

• Drug: topiramate
  • topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day. capsules are administered from week 4 through 25 of the trial
• Behavioral: Contingency Reinforcement
  • monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
• Drug: placebo + NonCR
  • participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1 topiramate + CR
  • topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
• Experimental: 2 topiramate + NonCR
  • Topiramate and random reinforcement irrespective of cocaine use
• Placebo Comparator: 4 Placebo + NonCR
• Active Comparator: 3 Placebo + CR
  • Placebo and contingency reinforcement for urine sample confirming cocaine abstinence

Primary Measures

• proportion of subjects achieving 3 consecutive weeks of cocaine abstinence as measured by urine samples free of cocaine metabolites
  • Time Frame: Urine samples collected 3 times weekly from week 1 through 26
    Safety Issue?: No

Secondary Measures

• symptom checklist
  • Time Frame: weekly
    Safety Issue?: Yes

Inclusion Criteria:

• 18 - 55 years old
• active opioid and cocaine dependence
• seeking treatment for cocaine and opioid dependence
• eligible for methadone maintenance per state and federal regulations
• able and willing to provide a urine sample thrice a week
• willing to answer questionnaires on a weekly basis
• willing to provide breath samples for presence of alcohol thrice weekly
• fluent in the English language

Exclusion Criteria:

• allergy to sulfonamide drugs
• diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to a risk of acidosis
• history of nephrolithiasis
• HIV positive individuals who meet AIDS criteria by CDC criteria or are taking antiretroviral medications
• serious psychiatric illness (psychosis, dementia)
• glaucoma or family history of glaucoma
• prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine samples on demand
• female participants: being pregnant, lactating, or unwilling to use an effective method of contraception
• use of antiepileptic agents
• benzodiazepine dependence
• latex allergy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johns Hopkins University

Overall Clinical Trial Officials and Contacts

Annie Umbricht, M.D. Principal Investigator Johns Hopkins University  

Overall Contact: Toran Claireborne, BA 410-550-1102 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685178

Study ID Number: R01DA021808

ClinicalTrials.gov Identifier: NCT00685178

Health Authority: United States: Food and Drug Administration