Varenicline Treatment for Active Alcoholic Smokers
2 other identifiers
interventional
33
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
May 30, 2014
CompletedFebruary 5, 2018
January 1, 2018
2.6 years
May 2, 2011
May 1, 2014
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
Prolonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
12 weeks
Secondary Outcomes (2)
Prolonged Abstinence at 24 Weeks
week 24
Heavy Drinking Days at End of Treatment
week 12
Study Arms (2)
Varenicline
ACTIVE COMPARATORvarenicline 1.0 mg twice daily for 12 weeks
Sugar Pil
PLACEBO COMPARATORVarenicline look alike sugar pill twice daily for 12 weeks
Interventions
varenicline 1.0 mg dose, twice daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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;
- Subject is alcohol dependence based on DSM IV criteria as assessed by the Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
- Subject is currently drinking alcoholic beverages as assessed by the physician investigator;
- 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;
- Subject must be able to complete all the study visits;
- Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments;
- Subject must be in good general health as determined by medical history, physical exam and physician investigator;
- Subject must provide written informed consent to participate in the study;
You may not qualify if:
- 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);
- Subject has another household member in study;
- Known allergy to varenicline;
- 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;
- Subject has an unstable medical condition as determined by the physician investigator;
- 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;
- Subject has a personal history of renal failure or is on renal dialysis;
- Subject has a current moderate or severe depression as assessed by the Center for Epidemiologic Studies-Depression survey (CES-D) and physician investigator;
- 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");
- Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder;
- Subject currently uses of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days;
- Subject currently has cancer \[excluding non melanoma skin cancer\] not in remission (cancer free for 5 years or more);
- Subject currently has Type 1 diabetes;
- Subject has untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100;
- Subject is currently on treatment with another investigational drug (within 30 days of study entry);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Franciscan Skemp Hospital
La Crosse, Wisconsin, 54601, United States
Related Publications (2)
Hurt RT, Ebbert JO, Croghan IT, Schroeder DR, Hurt RD, Hays JT. Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trial. Drug Alcohol Depend. 2018 Mar 1;184:12-17. doi: 10.1016/j.drugalcdep.2017.11.017. Epub 2018 Jan 2.
PMID: 29324248RESULTLivingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard Hurt
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D. Hurt, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
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
- PhD
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 4, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2014
Study Completion
March 1, 2014
Last Updated
February 5, 2018
Results First Posted
May 30, 2014
Record last verified: 2018-01