New Treatment for Alcohol and Nicotine Dependence

NCT01182766 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 155975R01AA019720-02
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Alcohol Dependence; Nicotine Dependence

Keywords

alcohol; alcoholism; nicotine; cigarette

Outcome Measures

Primary Outcomes (2)

• Continuous Smoking Abstinence in the Last 4 Weeks of Treatment Continuous Smoking Abstinence in the Last 4 Weeks of Treatment

  No smoking in the last 4 weeks of the 18-week treatment with an expired carbon monoxide level of \<10 ppm as the biochemical verification. We used the intent-to-treat assumption, where missing smoking data were considered as smoking.

  Week 15 - 18 of the 18-week medication treatment

• Percentage of Heavy Drinking Days (PHDD) in the Last 4 Weeks of Treatment

  A heavy drinking day is defined as \>= 5 standard drinking units for men and \>= 4 standard drinking units for women. We calculated the PHDD used the intent-to-treat assumption, where missing drinking data were considered as heavy drinking.

  Week 15 - 18 of the 18-week medication treatment

Secondary Outcomes (2)

• Quality of Life in the Last 4 Weeks of Treatment

  Week 15 - 18 of the 18-week medication treatment

• Craving for Alcohol and Cigarettes in the Last 4 Weeks of Treatment

  Week 15 - 18 of the 18-week medication treatment

Study Arms (3)

Low-Dose Topiramate

EXPERIMENTAL

Low-dose topiramate (125 mg) with brief behavioral enhancement therapy

Drug: Low-Dose Topiramate

High-Dose Topiramate

EXPERIMENTAL

High-dose topiramate (250 mg) with brief behavioral enhancement therapy

Drug: High-Dose Topiramate

Placebo

PLACEBO COMPARATOR

Placebo with brief behavioral enhancement therapy

Drug: Placebo

Interventions

Low-Dose Topiramate DRUG

Low-dose topiramate (up to 125 mg/day) with brief behavioral enhancement therapy

Also known as: Topamax

Low-Dose Topiramate

Placebo DRUG

Placebo with brief behavioral enhancement therapy

Also known as: sugar pill

Placebo

High-Dose Topiramate DRUG

High-dose topiramate (up to 250 mg/day) with brief behavioral enhancement therapy

Also known as: Topamax

High-Dose Topiramate

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Please contact site for additional information

Sponsors & Collaborators

• University of Virginia: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• M.D. Anderson Cancer Center: collaborator
• University of California, San Diego: collaborator

Study Sites (4)

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Center for Addiction Research & Education

Charlottesville, Virginia, 22911, United States

Location

University of Virginia Center for Addiction Research & Education

Richmond, Virginia, 23294, United States

Location

Related Links

• (UVA CARE Website)

MeSH Terms

Conditions

Alcoholism; Tobacco Use Disorder

Interventions

Topiramate; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses

Results Point of Contact

• Title: Dr. Nassima Ait-Daoud Tiouririne
• Organization: University of Virginia School of Medicine

NAT7B@uvahealth.org

(434) 243-0570

Study Officials

• Nassima Ait-Daoud Tiouririne, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Robert M Anthenelli, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Paul M Cinciripini, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Bankole A Johnson, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of UVA Center for Addiction Research and Education

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 17, 2010
• Study Start: November 1, 2011
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)