Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

NCT ID: NCT00747643

Last Updated: 2013-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-08-31

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.

Conditions

Tobacco Dependence

Keywords

tobacco; nicotine; smoking; reward; reinforcement; craving; cues; conditioned stimuli; cue reactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

varenicline

Intervention Type: DRUG

Participants in this group received varenicline according to the schedule in the Arm Description.

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.

Interventions

varenicline

Participants in this group received varenicline according to the schedule in the Arm Description.

Intervention Type: DRUG

placebo

Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.

Intervention Type: DRUG

Other Intervention Names

Chantix™

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Brandon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

106842

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-15444

Identifier Type: -

Identifier Source: org_study_id