Varenicline Treatment for Active Alcoholic Smokers
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking; Tobacco Dependence; Alcohol Dependence
Intervention: Varenicline (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Richard D. Hurt, MD, Principal Investigator, Affiliation: Mayo Clinic
Summary
Alcohol dependence is a significant and prevalent public health problem affecting
approximately 4% of the U. S. adult population. Individuals with alcohol dependence actively
seek treatment annually, and long-term alcohol abstinence varies from 40-60%. Because of the
high smoking prevalence and trends toward heavier smoking, alcoholic smokers are at high
risk for both morbidity and mortality related to alcohol consumption and tobacco dependence.
Although several studies have evaluated pharmacotherapy for tobacco dependence in recovering
alcoholic smokers, few have evaluated pharmacotherapy for tobacco dependence among currently
drinking alcoholic smokers.
Varenicline is the most effective medication currently available for treating tobacco
dependence. While some randomized trials have included recovering alcoholics, active
alcoholism has been an exclusion criteria for these trials. Thus, this proposal would be
the first such clinical trial in currently drinking alcoholic smokers. In addition to
helping smokers to stop smoking, varenicline has also been shown to reduce alcohol
consumption in rats. The goal of this proposal is to explore the potential efficacy of
varenicline for treating tobacco dependence and reducing drinking among alcohol dependent
smokers.
The investigators hypothesize that 12 weeks of treatment with varenicline, a partial
nicotinic acetylcholine receptor agonist will be more effective than placebo in treating
tobacco dependence and reducing nicotine withdrawal symptoms in currently drinking alcoholic
smokers. The investigators will also explore whether varenicline has an effect on drinking
behavior among currently drinking alcoholics. The investigators propose the following
specific aims to test these hypotheses in 70 currently drinking alcoholic smokers recruited
at the Mayo Clinic in Rochester, Minnesota.
Clinical Details
Official title: Varenicline Treatment for Active Alcoholic Smokers
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
Secondary outcome: Prolonged Abstinence at 24 WeeksHeavy Drinking Days at End of Treatment
Detailed description:
Seventy smokers who are currently alcohol dependent will be enrolled to this study. If
found to be study eligible they will be randomized to either active varenicline or placebo
for 12 weeks. During these two weeks, they will be seen either weekly or biweekly. At the
end of treatment, they will be followed up for an addition 12 weeks. Their last study visit
will be 6 months after randomization.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or non-pregnant female cigarette smokers 18-years-of-age or older and reporting
smoking at least an average of 10 cigarettes per day for the past year;
2. Subject is alcohol dependence based on DSM IV criteria as assessed by the
Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
3. Subject is currently drinking alcoholic beverages as assessed by the physician
investigator;
4. Subject is a female subject of non-childbearing potential or a female subject of
childbearing potential - who is using contraceptives and has a negative pregnancy
test result;
5. Subject must be able to complete all the study visits;
6. Subject has the ability to participate fully in all aspects of the study and keep
scheduled appointments;
7. Subject must be in good general health as determined by medical history, physical
exam and physician investigator;
8. Subject must provide written informed consent to participate in the study;
Exclusion Criteria:
1. Subject is a female who is pregnant, lactating or likely to become pregnant during
the trial and not willing to use an acceptable form of contraception during the
medication phase, (for women of child-bearing potential, a pregnancy test will be
performed prior to entry into the study and at the end of the medication phase);
2. Subject has another household member in study;
3. Known allergy to varenicline;
4. Subject is currently (in previous 30 days) using other behavioral or pharmacologic
tobacco cessation program (i. e., behavioral therapy, nicotine replacement therapy,
clonidine, varenicline, bupropion SR, nortriptyline or doxepin) and unwilling or
unable to discontinue use;
5. Subject has an unstable medical condition as determined by the physician
investigator;
6. Subject describes having a medical history of: a) unstable angina; b) myocardial
infarction within the past 3 months; c) coronary angioplasty or d) an untreated
cardiac dysrhythmia;
7. Subject has a personal history of renal failure or is on renal dialysis;
8. Subject has a current moderate or severe depression as assessed by the Center for
Epidemiologic Studies-Depression survey (CES-D) and physician investigator;
9. Subject has, as defined by the Columbia Suicide Severity Rating Scale (C-SSRS)
current non-specific suicidal thoughts, or have a lifetime history of a suicidal
attempt (defined as "potentially self-injurious act committed with at least some wish
to die, as a result of act");
10. Subject has current (past 30 days) major depressive disorder or has a history of
another psychiatric disorder such as psychosis or bipolar disorder;
11. Subject currently uses of other tobacco products (i. e. pipe, cigar, smokeless
tobacco) within the past 30 days;
12. Subject currently has cancer [excluding non melanoma skin cancer] not in remission
(cancer free for 5 years or more);
13. Subject currently has Type 1 diabetes;
14. Subject has untreated hypertension or baseline systolic blood pressure > 180 or
diastolic > 100;
15. Subject is currently on treatment with another investigational drug (within 30 days
of study entry);
Locations and Contacts
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States
Franciscan Skemp Hospital, LaCrosse, Wisconsin 54601, United States
Additional Information
Starting date: June 2011
Last updated: May 1, 2014
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