Clinical trial NCT01092702: Varenicline For Smokers In Recovery From Alcohol Dependence
Official title: A Pilot Study of Varenicline for Tobacco Dependence Treatment in Recovering Alcoholic Smokers: the Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tobacco Abstinence
Keywords: Tobacco Dependence
Smoking
Tobacco Cessation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Biochemically Confirmed Abstinence From Smoking
timeFrame: 12 weeks from start of medication
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Nicotine Research Program
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James T Hays, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jsat.2010.08.009. Epub 2010 Oct 13.