Phase 3 N=236 Randomized Quadruple-blind Treatment

New Treatment for Alcohol and Nicotine Dependence

Alcohol Dependence · Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01182766 ↗

Enrolled (actual)

236

Serious AEs

9.3%

Results posted

Oct 2025

Primary outcome: Primary: Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment — 2; 5; 6 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Low-Dose Topiramate (Drug); Placebo (Drug); High-Dose Topiramate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Oct 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment	2; 5; 6	—
PRIMARY Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment	62.8; 65.1; 59.3	—
SECONDARY Quality of Life in the Last 4 Weeks of Treatment	40.2; 37.1; 35.4; 57.7; 54.2; 57.9	—
SECONDARY Craving for Alcohol and Cigarettes in the Last 4 Weeks of Treatment	12.3; 18.4; 14.3; 17.4; 24.6; 18.2	—

Summary

This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.

Eligibility Criteria

Inclusion Criteria

Males and females who have given written informed consent
Subjects must be above the age of 18
Good physical health
Diagnostic and Statistical Manual (DSM)-IV diagnosis of mild to severe alcohol use disorder
Smoking ≥ 5 cigarettes/day
Currently drinking at least 8 standard drink units (SDUs) per week for women and at least 15 SDUs per week in the 30 days prior to randomization
Subjects must provide evidence of stable residence
The pregnancy test for females of child-bearing potential at screen and prior to randomization must be negative. Additionally, women of child-bearing potential must be using an acceptable form of contraception.
Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
Willing to participate in a treatment program for alcohol and nicotine dependence

Exclusion Criteria

Please contact site for additional information

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01182766). 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.