Smoking Addiction
Conditions
Brief summary
The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.
Interventions
DRUGPlacebo
25mg look alike riboflavin tablets to match active study medication.
DRUGVarenicline
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
Sponsors
National Institute on Drug Abuse (NIDA)
The Mind Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 18 yrs to 55 yrs * smoker
Exclusion criteria
* Medical Contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes Per Smoking Day | up to 36 weeks | The number of cigarettes smoked were assessed only on a smoking day, i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Varenicline
Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily | 119 |
| Microcrystal Cellulose Microcrystal cellulose placebo
Placebo: 25mg look alike riboflavin tablets to match active study medication. | 99 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 64 | 50 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Varenicline | Microcrystal Cellulose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 99 Participants | 218 Participants |
| Region of Enrollment United States | 119 Participants | 99 Participants | 218 Participants |
| Sex: Female, Male Female | 81 Participants | 64 Participants | 145 Participants |
| Sex: Female, Male Male | 38 Participants | 35 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 119 | 0 / 99 |
| serious Total, serious adverse events | 0 / 119 | 0 / 99 |
Outcome results
Primary
Cigarettes Per Smoking Day
The number of cigarettes smoked were assessed only on a smoking day, i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks.
Time frame: up to 36 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Cigarettes Per Smoking Day | 4.9256 Cigarettes per smoking day | Standard Deviation 5.62357 |
| Microcrystal Cellulose | Cigarettes Per Smoking Day | 8.4989 Cigarettes per smoking day | Standard Deviation 8.53172 |