Phase 2
Completed N=171
Clinical Trial of Topiramate for Cocaine Addiction
Cocaine Dependence
Source: ClinicalTrials.gov NCT00685178 ↗
Enrolled (actual)
171
Serious AEs
7.0%
Results posted
Jul 2017
Primary outcomePrimary: 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
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.
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 |
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
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. Informational only — not medical advice.