Clinical trial NCT00747643: Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
Official title: Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: tobacco
nicotine
smoking
reward
reinforcement
craving
cues
conditioned stimuli
cue reactivity
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-09-05
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: We proposed the following primary hypotheses:

1. Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
2. Cue-provoked cravings (self-report and physiological responding) would be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.)
3. The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) would be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.)

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.

Eligibility criteria: Inclusion Criteria:

* 18-60 years of age
* Smoke at least 15 cigarettes daily
* Expired-air carbon monoxide (CO) \> 10 ppm
* Medically eligible to receive Varenicline.

Exclusion Criteria:

* Patients who are pregnant or lactating
* Who show evidence of renal dysfunction (BUN \> 25 mg/dL, or creatinine \> 1.3 mg/dL)
* Are using other smoking cessation medications
* Have current psychiatric disorders (i.e. major depression, manic depression, and/or psychotic episodes) as determined by the Structured Clinical Interview for DSM Disorders (SCID) (First et al., 1996), will be excluded

Primary outcomes:
measure: Tonic Craving Score (QSU) Based on Self Reports
timeFrame: 3 weeks per participant
measure: Cue-provoked Cravings
timeFrame: 3 weeks per participant
Secondary outcomes:
measure: Smoking Topography - Number of Puffs on a Cigarette
timeFrame: 3 weeks per participant
measure: A Measure of the Subjective Expected Value of a Cigarette
timeFrame: 3 weeks per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: