Tobacco Abstinence
Conditions
Keywords
Tobacco Dependence, Smoking, Tobacco Cessation
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.
Interventions
DRUGVarenicline
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Confirmed Abstinence From Smoking | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on 04/14/2008 and finished on 08/28/2008. Recruitment was in the general community of Rochester, Minnesota
Pre-assignment details
All potential participants consenting to enrollment completed a series of screening questionnaires. The questionnaires included demographic information, alcohol and smoking history, the the Center for Epidemiological Studies-Depressed Mood Scale, DAST-20, medical history and physical exam.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Everyone on study received Varenicline (2 mg/day) daily for 12 weeks | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 42.9 years STANDARD_DEVIATION 10.5 |
| cigarettes per day | 20.3 cigarettes per day STANDARD_DEVIATION 5 |
| Duration of alcohol recovery | 29 months |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Biochemically Confirmed Abstinence From Smoking
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.
Time frame: 12 weeks from start of medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Biochemically Confirmed Abstinence From Smoking | 10 participants |