Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00747643
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : November 29, 2011
Last Update Posted : December 16, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Condition Tobacco Dependence
Interventions Drug: varenicline
Drug: placebo
Enrollment 163
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 82 81
Completed 46 54
Not Completed 36 27
Reason Not Completed
Withdrawal by Subject             36             27
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 46 54 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 54 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
 100.0%
54
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 54 participants 100 participants
Female
18
  39.1%
21
  38.9%
39
  39.0%
Male
28
  60.9%
33
  61.1%
61
  61.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 54 participants 100 participants
46 54 100
1.Primary Outcome
Title Tonic Craving Score (QSU) Based on Self Reports
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 54
Mean (Standard Error)
Unit of Measure: Scores on a scale
3.53  (.21) 4.93  (.19)
2.Primary Outcome
Title Cue-provoked Cravings
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 54
Mean (Standard Error)
Unit of Measure: Scores on a scale
11.18  (.76) 14.61  (.69)
3.Secondary Outcome
Title Smoking Topography - Number of Puffs on a Cigarette
Hide Description # Puffs = total number of puffs taken at Assessment Session.
Time Frame 3 weeks per participant
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 54
Mean (Standard Error)
Unit of Measure: Puffs on a Cigarette
6.05  (.77) 9.86  (.76)
4.Secondary Outcome
Title A Measure of the Subjective Expected Value of a Cigarette
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 46 54
Mean (Standard Error)
Unit of Measure: Dollars
2.46  (.30) 3.72  (.28)
Time Frame 3 weeks per participant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/81 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Thomas H. Brandon, Ph.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1750
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00747643     History of Changes
Other Study ID Numbers: MCC-15444
106842 ( Other Identifier: USF IRB )
First Submitted: September 4, 2008
First Posted: September 5, 2008
Results First Submitted: July 27, 2011
Results First Posted: November 29, 2011
Last Update Posted: December 16, 2013