Phase 2 N=171 Randomized Quadruple-blind Treatment

Clinical Trial of Topiramate for Cocaine Addiction

Cocaine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00685178 ↗

Enrolled (actual)

171

Serious AEs

7.0%

Results posted

Jul 2017

Primary outcome: Primary: Proportion of Cocaine Positive Urine Samples Per Treatment Condition — 45.4; 42.7; 53.5; 46.5 percentage of positive urine samples — p=0.531

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: topiramate (Drug); Contingency Reinforcement (Behavioral); placebo + NonCR (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Cocaine Positive Urine Samples Per Treatment Condition	45.4; 42.7; 53.5; 46.5	0.531
SECONDARY Voucher Earnings	421.25; 343.26; 394.69; 203.51	<0.001 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00685178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.