Tobacco Use Disorder
Conditions
Keywords
tobacco, nicotine, cigarette smoking
Brief summary
The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.
Interventions
DRUGVarenicline
Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
DRUGPlacebo pill
Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
Sponsors
Pfizer
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Must smoke at least 10 cigarettes per day for past 6-months * Must have a working cellular or land-line phone
Exclusion criteria
* Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes * Must not be currently receiving tobacco dependence treatment counseling * Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler) * Must not have positive screen on SCID-I/NP Psychotic Screen * Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Reduction | At 6-month follow-up | 50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced. |
Countries
United States
Participant flow
Pre-assignment details
73 potential participants provided informed consent and were therefore Enrolled, however 10 of these did not meet all eligibility criteria as they were completing the baseline measures. We therefore Started 63 randomized participants as indicated in the Participant Flow module.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter. | 31 |
| Placebo Pill Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter. | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not attend a single session | 6 | 5 |
Baseline characteristics
| Characteristic | Varenicline | Placebo Pill | Total |
|---|---|---|---|
| Age, Continuous | 44.03 years STANDARD_DEVIATION 10.54 | 44.81 years STANDARD_DEVIATION 12.14 | 44.43 years STANDARD_DEVIATION 11.29 |
| Region of Enrollment United States | 31 participants | 32 participants | 63 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 31 | 16 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
Cigarette Reduction
50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
Time frame: At 6-month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Cigarette Reduction | 10 participants |
| Placebo Pill | Cigarette Reduction | 11 participants |