Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
236 participants
INTERVENTIONAL
2011-11-01
2017-10-06
Brief Summary
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Detailed Description
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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 gamma-aminobutyric acid (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 carbon monoxide (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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low-Dose Topiramate
Low-dose topiramate (125 mg) with brief behavioral enhancement therapy
Low-Dose Topiramate
Low-dose topiramate (up to 125 mg/day) with brief behavioral enhancement therapy
High-Dose Topiramate
High-dose topiramate (250 mg) with brief behavioral enhancement therapy
High-Dose Topiramate
High-dose topiramate (up to 250 mg/day) with brief behavioral enhancement therapy
Placebo
Placebo with brief behavioral enhancement therapy
Placebo
Placebo with brief behavioral enhancement therapy
Interventions
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Low-Dose Topiramate
Low-dose topiramate (up to 125 mg/day) with brief behavioral enhancement therapy
Placebo
Placebo with brief behavioral enhancement therapy
High-Dose Topiramate
High-dose topiramate (up to 250 mg/day) with brief behavioral enhancement therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
M.D. Anderson Cancer Center
OTHER
University of California, San Diego
OTHER
University of Virginia
OTHER
Responsible Party
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Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Addiction Research and Education
Principal Investigators
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Nassima Ait-Daoud Tiouririne, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Robert M Anthenelli, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Paul M Cinciripini, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Bankole A Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of California, San Diego
La Jolla, California, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Center for Addiction Research & Education
Charlottesville, Virginia, United States
University of Virginia Center for Addiction Research & Education
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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(UVA CARE Website)
Other Identifiers
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15597
Identifier Type: -
Identifier Source: org_study_id
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