Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

NCT00802412 | Completed Phase 2 Results DMC

• 1 other identifier: NEUA-003-08S
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Alcohol Dependence

Keywords

tobacco use disorders; alcoholism

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 8-12 of treatment.

Secondary Outcomes (1)

• Percent Relapsing to Any Drinking or Illicit Drug Use

  12-week treatment phase, 36-week combined treatment and follow-up

Study Arms (2)

Topiramate

OTHER

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.

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

90 participants, will receive matching placebo

Drug: Placebo

Interventions

Topiramate DRUG

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).

Also known as: Topamax

Topiramate

Placebo DRUG

Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (1)

• 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.

  PMID: 28029173 DERIVED

Related Links

• Click here for more information about this study: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

MeSH Terms

Conditions

Tobacco Use Disorder; Alcoholism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

Dually-dependent male smokers with high rates of SUDs and psychiatric disorders, thus not generalizable to other populations; topiramate dose lower than the dose found to reduce smoking in active alcoholics; attrition may have impacted results.

Results Point of Contact

• Title: Neal Doran, PhD
• Organization: VA San Diego

neal.doran@va.gov

8585528585

Study Officials

• Robert M. Anthenelli, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: January 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Locations

US (1)