Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Tobacco Dependence

Treatments: Drug: varenicline; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00747643

106842 (Other Identifier)

MCC-15444

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

163 participants in 2 patient groups, including a placebo group

Varenicline

Active Comparator 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.

Treatment:

Drug: varenicline

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo