Trial Outcomes & Findings for Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement (NCT NCT00747643)
NCT ID: NCT00747643
Last Updated: 2013-12-16
Results Overview
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.
COMPLETED
NA
163 participants
3 weeks per participant
2013-12-16
Participant Flow
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.
Participants completed a baseline evaluation including screening for inclusion and exclusion criteria, a medical evaluation, basic metabolic panel and pregnancy test for females. Participants who met all of the inclusion criteria were scheduled for the assessment sessions.
Participant milestones
| Measure |
Varenicline
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.
|
Placebo
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.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
|
Overall Study
COMPLETED
|
46
|
54
|
|
Overall Study
NOT COMPLETED
|
36
|
27
|
Reasons for withdrawal
| Measure |
Varenicline
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.
|
Placebo
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
36
|
27
|
Baseline Characteristics
Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
Baseline characteristics by cohort
| Measure |
Varenicline
n=46 Participants
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.
|
Placebo
n=54 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
54 participants
n=4 Participants
|
100 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 weeks per participantPopulation: Per Protocol
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.
Outcome measures
| Measure |
Varenicline
n=46 Participants
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.
|
Placebo
n=54 Participants
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.
|
|---|---|---|
|
Tonic Craving Score (QSU) Based on Self Reports
|
3.53 Scores on a scale
Standard Error .21
|
4.93 Scores on a scale
Standard Error .19
|
PRIMARY outcome
Timeframe: 3 weeks per participantPopulation: Per Protocol
Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"
Outcome measures
| Measure |
Varenicline
n=46 Participants
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.
|
Placebo
n=54 Participants
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.
|
|---|---|---|
|
Cue-provoked Cravings
|
11.18 Scores on a scale
Standard Error .76
|
14.61 Scores on a scale
Standard Error .69
|
SECONDARY outcome
Timeframe: 3 weeks per participantPopulation: Per Protocol
\# Puffs = total number of puffs taken at Assessment Session.
Outcome measures
| Measure |
Varenicline
n=46 Participants
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.
|
Placebo
n=54 Participants
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.
|
|---|---|---|
|
Smoking Topography - Number of Puffs on a Cigarette
|
6.05 Puffs on a Cigarette
Standard Error .77
|
9.86 Puffs on a Cigarette
Standard Error .76
|
SECONDARY outcome
Timeframe: 3 weeks per participantPopulation: Per Protocol
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).
Outcome measures
| Measure |
Varenicline
n=46 Participants
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.
|
Placebo
n=54 Participants
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.
|
|---|---|---|
|
A Measure of the Subjective Expected Value of a Cigarette
|
2.46 Dollars
Standard Error .30
|
3.72 Dollars
Standard Error .28
|
Adverse Events
Varenicline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas H. Brandon, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place