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.

• Drug: varenicline
  Participants in this group received varenicline according to the schedule in the Arm Description.
  Other Name: Chantix?
• Drug: placebo
  Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.

• Active Comparator: 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.
  Intervention: Drug: varenicline
• Placebo Comparator: 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.
  Intervention: Drug: placebo

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