Varenicline For Smokers In Recovery From Alcohol Dependence

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. Read our disclaimer for details. Identifier: NCT01092702
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : November 30, 2010
Last Update Posted : April 19, 2011
Information provided by:
Mayo Clinic

Brief Summary:
The goal of this proposal is to explore the potential effectiveness of varenicline to treat tobacco dependence among recovering alcoholic smokers who, as a group, are at high risk for tobacco-caused morbidity and mortality. In this open-label phase II clinical trial, we are proposing to enroll 32 recovering alcoholic smokers who are motivated to stop smoking. After the initial up titration of varenicline in week 1, all 32 subjects will receive a total of 2 mg/day of varenicline for 12 weeks. In addition to receiving varenicline, all subjects will receive brief behavioral counseling and our standard intervention at each visit during participation in the study.

Condition or disease Intervention/treatment Phase
Tobacco Abstinence Drug: Varenicline Phase 2 Phase 3

Detailed Description:

This is an open-label, phase II clinical trial. All subjects will be screened for study eligibility after providing informed consent. During the clinic screen visit the subjects are informed of the study, the study informed consent is signed by the subject and staff member, a series of screening tests are conducted and screening criteria are reviewed. Once enrolled in study, the subject will return for a face to face clinic visit weekly for the first 4 weeks (visits 3-6) and then biweekly for the last 8 weeks(visits 7-10). Target quit day is the day after visit 3 (week 1 visit).

During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily.

Subjects will return weekly for 4 weeks then bi-weekly for the remaining 8 weeks. The study end-date will be Week 12, which is also the end-of-treatment date.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial
Study Start Date : April 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Everyone on study will receive Varenicline daily for 12 weeks
Drug: Varenicline
During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily.
Other Names:
  • Varenicline Tartrate
  • Chantix (in the USA)
  • Champix (in Europe)

Primary Outcome Measures :
  1. Biochemically Confirmed Abstinence From Smoking [ Time Frame: 12 weeks from start of medication ]
    The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or non-pregnant female cigarette smoker; 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year.
  2. A history of alcohol dependence based on DSM IV criteria as assessed by the Alcohol Dependence Scale and the physician investigator
  3. A minimum of 6 months of abstinence from alcohol use as assessed by the physician investigator
  4. Subject must be able to complete all the study visits
  5. Subject must be in general good health as determined by medical history, physical exam and physician investigator
  6. Subject must provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Current treatment with another investigational drug.
  2. Current use (within past 30 days) of nicotine replacement therapy, bupropion, rimonabant, varenicline, nortriptyline, clonidine, or other medications known to be effective for treating tobacco dependence.
  3. Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder.
  4. Current (past 6 months) drug abuse corroborated by the Drug Abuse Screening Test (DAST-20) and physician interview.
  5. Regular use of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days.
  6. Females who are 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.
  7. A history of a major cardio-vascular event in the past 3 months including unstable angina, acute MI or coronary angioplasty.
  8. Known allergy to varenicline.

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 identifier (NCT number): NCT01092702

United States, Minnesota
Mayo Clinic Nicotine Research Program
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: James T Hays, MD Mayo Clinic

Publications of Results:
Responsible Party: James Taylor Hays, MD, Mayo Clinic Identifier: NCT01092702     History of Changes
Other Study ID Numbers: 08-00672
First Posted: March 25, 2010    Key Record Dates
Results First Posted: November 30, 2010
Last Update Posted: April 19, 2011
Last Verified: April 2011

Keywords provided by Mayo Clinic:
Tobacco Dependence
Tobacco Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs