Back to resultsTopiramate to Aid Smoking Cessation in Alcohol Dependent Men
Primary Purpose
Nicotine Dependence, Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topiramate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring tobacco use disorders, alcoholism
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).
Sites / Locations
- VA San Diego Healthcare System, San Diego, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Topiramate
Placebo
Arm Description
The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
90 participants, will receive matching placebo
Outcomes
Primary Outcome Measures
4-week Continuous Abstinence From Smoking
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
Secondary Outcome Measures
Percent Relapsing to Any Drinking or Illicit Drug Use
Alcohol or illicit drug use during treatment or follow up.
Full Information
NCT ID
NCT00802412
First Posted
December 3, 2008
Last Updated
December 6, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00802412
Brief Title
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Official Title
Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
Detailed Description
This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Alcohol Dependence
Keywords
tobacco use disorders, alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topiramate
Arm Type
Other
Arm Description
The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
90 participants, will receive matching placebo
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
Primary Outcome Measure Information:
Title
4-week Continuous Abstinence From Smoking
Description
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
Time Frame
Weeks 8-12 of treatment.
Secondary Outcome Measure Information:
Title
Percent Relapsing to Any Drinking or Illicit Drug Use
Description
Alcohol or illicit drug use during treatment or follow up.
Time Frame
12-week treatment phase, 36-week combined treatment and follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M. Anthenelli, MD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28029173
Citation
Anthenelli RM, Heffner JL, Wong E, Tibbs J, Russell K, Isgro M, Dinh E, Wehrle C, Worley MJ, Doran N. A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men. Alcohol Clin Exp Res. 2017 Jan;41(1):197-206. doi: 10.1111/acer.13279. Epub 2016 Dec 28.
Results Reference
derived
Links:
URL
http://www.pac-tarc.org/
Description
Click here for more information about this study: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
Learn more about this trial
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
We'll reach out to this number within 24 hrs