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

March 19, 2010
April 15, 2011
April 2008
September 2008   (final data collection date for primary outcome measure)
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.
  • To obtain preliminary evidence of the effect of a 12-week course of varenicline on the 7-day point prevalence smoking abstinence rates at end of treatment in 32 recovering alcoholic smokers [ Time Frame: week 12 ] [ 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.
  • To obtain preliminary estimates of the effect of a 12-week course of varenicline on symptoms of nicotine withdrawal. [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
    Subjects will complete the Minnesota Nicotine Withdrawal Questionnaire, incorporated into the Diary, for the week preceding their baseline assessment and the average of these withdrawal scores will be used as their baseline value. The withdrawal scores obtained following the target quit date will be analyzed as change from baseline. In all cases, confidence intervals (95%) will be used extensively to present estimates for the range of outcomes consistent with study findings.
Complete list of historical versions of study NCT01092702 on ClinicalTrials.gov Archive Site
Not Provided
to obtain preliminary estimates of the effect of a 12-week course of varenicline on prolonged smoking abstinence rates at 12 weeks. [ Time Frame: week 12 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Varenicline For Smokers In Recovery From Alcohol Dependence
A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Abstinence
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)
Varenicline
Everyone on study will receive Varenicline daily for 12 weeks
Intervention: Drug: Varenicline
Hays JT, Croghan IT, Schroeder DR, Ebbert JO, Hurt RD. Varenicline for tobacco dependence treatment in recovering alcohol-dependent smokers: an open-label pilot study. J Subst Abuse Treat. 2011 Jan;40(1):102-7. Epub 2010 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2009
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01092702
08-00672
No
James Taylor Hays, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: James T Hays, MD Mayo Clinic
Mayo Clinic
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP