CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Topiramate +1 moredrug
Likely dose
Topiramate 300 mg/day for 13 weeksAI-extracted
Key inclusion· 7
  • ✓Age 18 years or older
  • ✓Current DSM-IV diagnoses of both cocaine dependence and alcohol dependence confirmed by SCID
  • ✓Recent substantial cocaine use: at least $200-worth in past 30 days
  • ✓Recent heavy alcohol use: minimum 48 standard drinks (≥12 drinks/week average) in a consecutive 30-day period during the 90 days prior to intake, with ≥2 days of heavy drinking (≥5 drinks/day for males, ≥4 drinks/day for females)
Key exclusion· 13
  • ✕Abstinent from cocaine or alcohol for 30 consecutive days prior to consent
  • ✕Dependence on any substance other than cocaine and alcohol (except nicotine and cannabis)
  • ✕Current use of psychoactive medications including anti-seizure medications (except occasional Benadryl for sleep), phenytoin, or carbonic anhydrase inhibitors
  • ✕History of schizophrenia, any psychotic disorder, organic mental disorder, or other clinically significant psychiatric disorder that interferes with study participation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00167245
NCT00167245Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Double-blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence

Kyle Kampman·interventional·Posted Sep 14, 2005·Updated Jul 7, 2020

In Brief

A Phase 2 clinical trial evaluating Topiramate and placebo for Alcoholism and Cocaine Dependence. Completed, enrolled 170 participants across 1 site.

Detailed Summary

The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism, Cocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartSep 1, 2004
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.8 years ago

Interventions

Topiramatedrug

300mg/day for 13 weeks

placebodrug

placebo pills