A Phase 4 interventional study of Placebo and Varenicline in Smoking Addiction, sponsored by The Mind Research Network. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by The Mind Research Network · Phase 4, Interventional, and Treatment
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.
540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.
This study's enrollment of 218 is above the median of 72 across 391 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →The Mind Research Network is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Varenicline
Drug: Varenicline
Microcrystal cellulose placebo
Drug: Placebo
25mg look alike riboflavin tablets to match active study medication.
Also known as: riboflavin
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
Also known as: Chantix
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
| Milestone | Varenicline | Microcrystal Cellulose |
|---|---|---|
| Started | 119 | 99 |
| Completed | 53 | 46 |
| Not completed | 66 | 53 |
| Withdrew: Lost to follow-up | 64 | 50 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Physician decision | 1 | 1 |
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.
| Cigarettes per smoking day | Varenicline | Microcrystal Cellulose |
|---|---|---|
| Cigarettes Per Smoking Day | 4.9256 ± 5.62357 | 8.4989 ± 8.53172 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline | — | 0/119 (0%) | 0/119 (0%) |
| Microcrystal Cellulose | — | 0/99 (0%) | 0/99 (0%) |
| Age, Categorical(Participants) | Varenicline | Microcrystal Cellulose | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 119 | 99 | 218 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Varenicline | Microcrystal Cellulose | Total |
|---|---|---|---|
| Female | 81 | 64 | 145 |
| Male | 38 | 35 | 73 |
| Region of Enrollment(Participants) | Varenicline | Microcrystal Cellulose | Total |
|---|---|---|---|
| United States | 119 | 99 | 218 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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