An interventional study of varenicline and placebo in Tobacco Dependence, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-16.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable and Interventional
The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.
We proposed the following primary hypotheses:
A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation).
Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 163 is above the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Exclusion Criteria:
For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
Drug: varenicline
Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
Drug: placebo
Participants in this group received varenicline according to the schedule in the Arm Description.
Also known as: Chantix™
Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.
Tonic Craving Score (QSU) Based on Self Reports
Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.
Time frame: 3 weeks per participant
Cue-provoked Cravings
Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"
Time frame: 3 weeks per participant
Smoking Topography - Number of Puffs on a Cigarette
# Puffs = total number of puffs taken at Assessment Session.
Time frame: 3 weeks per participant
A Measure of the Subjective Expected Value of a Cigarette
The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).
Time frame: 3 weeks per participant
To achieve a sample size of 100 following attrition, we screened 573 smokers from the community and randomized 100 non-treatment seeking daily smokers to the two conditions. Smokers who were using other smoking cessation medications, or who had current mood or psychotic disorders were excluded.
| Milestone | Varenicline | Placebo |
|---|---|---|
| Started | 82 | 81 |
| Completed | 46 | 54 |
| Not completed | 36 | 27 |
| Withdrew: Withdrawal by subject | 36 | 27 |
Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.
| Scores on a scale | Varenicline | Placebo |
|---|---|---|
| Tonic Craving Score (QSU) Based on Self Reports | 3.53 ± .21 | 4.93 ± .19 |
# Puffs = total number of puffs taken at Assessment Session.
| Puffs on a Cigarette | Varenicline | Placebo |
|---|---|---|
| Smoking Topography - Number of Puffs on a Cigarette | 6.05 ± .77 | 9.86 ± .76 |
Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"
| Scores on a scale | Varenicline | Placebo |
|---|---|---|
| Cue-provoked Cravings | 11.18 ± .76 | 14.61 ± .69 |
The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).
| Dollars | Varenicline | Placebo |
|---|---|---|
| A Measure of the Subjective Expected Value of a Cigarette | 2.46 ± .30 | 3.72 ± .28 |
Collected over 3 weeks per participant. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline | — | 0/82 (0%) | 0/82 (0%) |
| Placebo | — | 0/81 (0%) | 0/81 (0%) |
| Age, Categorical(Participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 54 | 100 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| Female | 18 | 21 | 39 |
| Male | 28 | 33 | 61 |
| Region of Enrollment(participants) | Varenicline | Placebo | Total |
|---|---|---|---|
| United States | 46 | 54 | 100 |
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H. Lee Moffitt Cancer Center and Research Institute