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Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement


N/A
18 Years
60 Years
Not Enrolling
Both
Tobacco Dependence

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Trial Information

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Outcome Measure:

Tonic Craving Score (QSU) Based on Self Reports

Outcome 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.

Outcome Time Frame:

3 weeks per participant

Safety Issue:

No

Principal Investigator

Thomas Brandon, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-15444

NCT ID:

NCT00747643

Start Date:

September 2008

Completion Date:

August 2010

Related Keywords:

  • Tobacco Dependence
  • tobacco
  • nicotine
  • smoking
  • reward
  • reinforcement
  • craving
  • cues
  • conditioned stimuli
  • cue reactivity
  • Smoking
  • Tobacco Use Disorder

Name

Location
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612