Clinical Trial of Topiramate for Cocaine Addiction - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00685178

Purpose

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

Condition	Intervention	Phase
Cocaine Dependence	Drug: topiramate Behavioral: Contingency Reinforcement Drug: placebo + NonCR	Phase II

Drug Information available for: Cocaine hydrochloride Topiramate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Trial of Topiramate for Cocaine Addiction

Further study details as provided by Johns Hopkins University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	350
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 topiramate + CR: Experimental topiramate and contingency reinforcement for urine sample confirming cocaine abstinence	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
2 topiramate + NonCR: Experimental Topiramate and random reinforcement irrespective of cocaine use	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
4 Placebo + NonCR: Placebo Comparator	Drug: placebo + NonCR participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
3 Placebo + CR: Active Comparator Placebo and contingency reinforcement for urine sample confirming cocaine abstinence	Behavioral: Contingency Reinforcement monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685178

Contacts

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

Locations

United States, Maryland
Behavioral Pharmacology Research Unit	Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Annie Umbricht, M.D.
Sub-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.

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Annie Umbricht, M.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University School of Medicine ( Annie Umbricht, M.D. )
Study ID Numbers:	R01DA021808, R01DA021808
Study First Received:	May 23, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00685178 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

addiction
drug dependence
stimulant

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Behavior, Addictive
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Cardiovascular Agents
Neuroprotective Agents
Anesthetics, Local
Anti-Obesity Agents

Methadone
Dopamine
Mental Disorders
Substance-Related Disorders
Vasoconstrictor Agents
Topiramate
Dopamine Agents
Peripheral Nervous System Agents
Cocaine
Anticonvulsants

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Neuroprotective Agents
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders

Topiramate
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Anesthetics, Local
Anti-Obesity Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009