Phase 2
Completed N=132
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Nicotine Dependence · alcohol dependence
Source: ClinicalTrials.gov NCT00802412 ↗
Enrolled (actual)
132
Serious AEs
3.1%
Results posted
Jan 2017
Primary outcomePrimary: 4-week Continuous Abstinence From Smoking — 7.9; 10.6 percentage of participants abstinent
Summary
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 4-week Continuous Abstinence From Smoking |
7.9; 10.6 | — |
| SECONDARY Percent Relapsing to Any Drinking or Illicit Drug Use |
31.8; 27.3 | 0.51 |
Eligibility Criteria
Inclusion Criteria
Subjects will be included if they:
- are 18-70 years of age, inclusive;
- are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);
- are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;
- are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;
Exclusion Criteria
Subjects will be excluded if they:
- have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;
- have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;
- have a history of known hypersensitivity to topiramate;
- in the investigator's judgment, pose a current suicidal or homicidal risk;
- have taken any investigational drug within 30 days of baseline; and
- have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).
Data sourced from ClinicalTrials.gov (NCT00802412). 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.