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Varenicline For Smokers In Recovery From Alcohol Dependence

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01092702
First received: March 19, 2010
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Tobacco Abstinence
 Drug: Varenicline
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Smoking
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biochemically Confirmed Abstinence From Smoking [ Time Frame: 12 weeks from start of medication ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Varenicline
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092702

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

Publications:

Responsible Party: James Taylor Hays, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01092702     History of Changes
Other Study ID Numbers: 08-00672
Study First Received: March 19, 2010
Results First Received: October 28, 2010
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Tobacco Dependence
Smoking
Tobacco Cessation

Additional relevant MeSH terms:
Alcoholism
Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013