Phase 3
Completed N=236
New Treatment for Alcohol and Nicotine Dependence
Source: ClinicalTrials.gov NCT01182766 ↗Enrolled (actual)
236
Serious AEs
9.3%
Results posted
Oct 2025
Primary outcomePrimary: Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment — 2; 5; 6 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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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. Informational only — not medical advice.