Clinical Trial of Topiramate for Cocaine Addiction - Tabular View

Tracking Information

First Received Date ^ICMJE

May 23, 2008

Last Updated Date

September 1, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00685178 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

symptom checklist [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clinical Trial of Topiramate for Cocaine Addiction

Official Title ^ICMJE

Clinical Trial of Topiramate for Cocaine Addiction

Brief 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

is safe and acceptable to methadone patients
reduces cocaine use
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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cocaine Dependence

Intervention ^ICMJE

Drug: topiramate
Behavioral: Contingency Reinforcement
Drug: placebo + NonCR

Study Arms / Comparison Groups

Experimental: topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
Experimental: Topiramate and random reinforcement irrespective of cocaine use
Active Comparator: Placebo and contingency reinforcement for urine sample confirming cocaine abstinence

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

350

Estimated Completion Date

July 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toran Claireborne, BA	410-550-1102
Contact: Apexa Patel, BA	410-550-1102

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00685178

Responsible Party

Annie Umbricht, M.D., Johns Hopkins University School of Medicine

Study ID Numbers ^ICMJE

R01DA021808, R01DA021808

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Annie Umbricht, M.D.

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP