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New Treatment for Alcohol and Nicotine Dependence

This study is currently recruiting participants.
Verified March 2017 by Nassima Ait-Daoud Tiouririne, University of Virginia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182766
First Posted: August 17, 2010
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
M.D. Anderson Cancer Center
University of California, San Diego
Information provided by (Responsible Party):
Nassima Ait-Daoud Tiouririne, University of Virginia
  Purpose
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.

Condition Intervention Phase
Alcohol Dependence Nicotine Dependence Drug: Topiramate with brief behavioral enhancement therapy Drug: Placebo with brief behavioral enhancement therapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High and Low Dose Topiramate for the Treatment of Alcohol-Dependent Smokers

Resource links provided by NLM:


Further study details as provided by Nassima Ait-Daoud Tiouririne, University of Virginia:

Primary Outcome Measures:
  • percent heavy drinking days, continuous abstinence rate for smoking [ Time Frame: In the last 4 weeks of treatment ]
    The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for PHDD.Continuous abstinence in smoking is determined by a combination of self-report and CO monitoring after the quit date


Secondary Outcome Measures:
  • Quality of life [ Time Frame: In the last 4 weeks of treatment ]
    Quality of life will be assessed using The Quality of Life Enjoyment and Satisfaction Questionnaire

  • Craving for alcohol and nicotine [ Time Frame: During the last 4 weeks of treatment ]
    alcohol and nicotine craving scales will be used to monitor craving


Estimated Enrollment: 294
Study Start Date: September 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: topiramate
topiramate with brief behavioral enhancement therapy
Drug: Topiramate with brief behavioral enhancement therapy
high-dose topiramate (up to 250 mg/day), or low-dose topiramate (up to 125 mg/day)
Other Name: Topamax
Placebo Comparator: Placebo
Placebo with brief behavioral enhancement therapy
Drug: Placebo with brief behavioral enhancement therapy
placebo
Other Name: sugar pill

Detailed Description:

We propose a novel pharmacological strategy for treating alcohol and nicotine dependence concomitantly.

The reinforcing effects of both alcohol and nicotine are mediated through the cortico-mesolimbic dopamine (CMDA) system, and the concomitant use of both drugs enhances their pharmacological effects. We propose a better approach to control dopamine (DA) effects by contemporaneous indirect modulation of DA release and its functional expression. Both DA release from its cell bodies in the ventral tegmental area and the expression of its reinforcing effects through the cortico-mesolimbic system are modulated by GABA efferents under the tonic control of glutamate-mediated excitatory amino acid pathways. Thus, it is reasonable to hypothesize that a medication that facilitates cortico-mesolimbic GABAergic function and inhibits glutamate action should diminish both nicotine's and alcohol's reinforcing effects by inhibiting the release of midbrain DA and its functional expression through pathways projecting from the nucleus accumbens to the cortex. The promise of this novel approach is exemplified by our recent proof-of-concept demonstration that topiramate compared with placebo significantly improved smoking abstinence rates and decreased serum cotinine levels among alcohol dependent smokers. An important clinical effect of topiramate in alcohol-dependent individuals appears to be that its anti-withdrawal effects promote the gradual tapering of drinking. Hence, due to this unique anti-withdrawal effect of topiramate, we propose to adopt the same methodology for treating alcohol-dependent individuals, as is common practice with smokers, of setting a target quit date (TQD) after which relapse to either drug can be measured. We propose an 18-week, double-blind clinical trial with follow-up visits at 1 month and 3 months, in which alcohol-dependent smokers will receive brief behavioral compliance enhancement treatment (BBCET) plus a smoking self-help manual as their psychosocial treatment, and will be randomized to receive placebo,high-dose topiramate (up to 250 mg/day), or low-dose topiramate (up to 125 mg/day) to prevent relapse to heavy drinking and smoking. Each of the 3 treatment arms shall contain 98 individuals, with a total N of 294.

The TQD will occur at the beginning of the 6th week of treatment. Our primary objective is to determine whether both low- and high-dose topiramate will be more efficacious than placebo at reducing the percentage of heavy drinking days and increasing the continuous abstinence rate for smoking determined by a combination of self-report and CO monitoring after the TQD and in the last 4 weeks of treatment. We also will be able to determine whether a lower dose of topiramate is as efficacious as the higher dose and, therefore, is associated with a lower adverse profile. Our secondary objectives are to test whether topiramate will be more efficacious than placebo at improving quality of life and reducing craving after the TQD and in the last 4 weeks of treatment and whether this improvement will be sustained in the follow-up phase.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females who have given written informed consent
  • Subjects must be above the age of 18
  • Good physical health
  • 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:

Please contact site for additional information

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182766


Contacts
Contact: Eva Jenkins-Mendoza 1-888-882-2345 emj9c@virginia.edu

Locations
United States, California
University of California, San Diego Active, not recruiting
La Jolla, California, United States, 92093
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: O'Neak Henigan    713-745-4472    OCHenigan@manderson.org   
Principal Investigator: Paul M Cinciripini, Ph.D.         
United States, Virginia
University of Virginia Center for Addiction Research & Education Active, not recruiting
Charlottesville, Virginia, United States, 22911
University of Virginia Center for Addiction Research & Education Active, not recruiting
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
University of Virginia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
M.D. Anderson Cancer Center
University of California, San Diego
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Responsible Party: Nassima Ait-Daoud Tiouririne, Associate Professor, Director of UVA Center for Addiction Research and Education, University of Virginia
ClinicalTrials.gov Identifier: NCT01182766     History of Changes
Other Study ID Numbers: 15597
5R01AA019720-02 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2010
First Posted: August 17, 2010
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nassima Ait-Daoud Tiouririne, University of Virginia:
alcohol
alcoholism
nicotine
cigarette

Additional relevant MeSH terms:
Alcoholism
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Nicotine
Topiramate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents