Clinical Trial of Topiramate for Cocaine Addiction
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ClinicalTrials.gov Identifier: NCT00685178 |
Recruitment Status
:
Completed
First Posted
: May 28, 2008
Results First Posted
: July 11, 2017
Last Update Posted
: July 11, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Dependence | Drug: topiramate Behavioral: Contingency Reinforcement Drug: placebo + NonCR | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Clinical Trial of Topiramate for Cocaine Addiction |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | September 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 topiramate + CR
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 Other Names:
Behavioral: Contingency Reinforcement
monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
Other Name: contingency management
|
Experimental: 2 topiramate + NonCR
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 Other Names:
|
Placebo Comparator: 4 Placebo + NonCR |
Drug: placebo + NonCR
participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
Active Comparator: 3 Placebo + CR
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
Other Name: contingency management
|
- Proportion of Cocaine Positive Urine Samples Per Treatment Condition [ Time Frame: Urine samples collected 3 times weekly from week 1 through 26 ]Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)
- Voucher Earnings [ Time Frame: 12 weeks (Weeks 8-20) ]
Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20.
Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685178
United States, Maryland | |
Behavioral Pharmacology Research Unit | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Annie Umbricht, M.D. | Johns Hopkins University |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00685178 History of Changes |
Other Study ID Numbers: |
R01DA021808 ( U.S. NIH Grant/Contract ) |
First Posted: | May 28, 2008 Key Record Dates |
Results First Posted: | July 11, 2017 |
Last Update Posted: | July 11, 2017 |
Last Verified: | June 2017 |
Keywords provided by Johns Hopkins University:
addiction drug dependence stimulant |
Additional relevant MeSH terms:
Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Topiramate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Anticonvulsants Neuroprotective Agents Protective Agents Anti-Obesity Agents |