Clinical Trial of Topiramate for Cocaine Addiction
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: topiramate (Drug); Contingency Reinforcement (Behavioral); placebo + NonCR (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Annie Umbricht, M.D., Principal Investigator, Affiliation: Johns Hopkins University
Overall contact:
Toran Claireborne, BA, Phone: 410-550-1102
Summary
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
Clinical Details
Official title: Clinical Trial of Topiramate for Cocaine Addiction
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: proportion of subjects achieving 3 consecutive weeks of cocaine abstinence as measured by urine samples free of cocaine metabolites
Secondary outcome: symptom checklist
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Toran Claireborne, BA, Phone: 410-550-1102
Behavioral Pharmacology Research Unit, Baltimore, Maryland 21224, United States; Recruiting
Annie Umbricht, M.D., Principal Investigator
George E Bigelow, Ph.D., Sub-Investigator
Eric C Strain, M.D., Sub-Investigator
Miriam Mintzer, Ph.D., Sub-Investigator
Erin Winstanley, Ph.D., Sub-Investigator
Additional Information
Starting date: February 2007
Ending date: July 2011
Last updated: May 27, 2008
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