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Completed

NCT Number: NCT00747643

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

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.

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

We proposed the following primary hypotheses:

  • Tonic (i.e., non-cue-provoked) craving levels would be lower in participants receiving varenicline versus placebo.
  • 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.)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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

Other names: Chantix™

Placebo

Drug

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

Primary outcomes

  1. Tonic Craving Score (QSU) Based on Self Reports

    Time frame: 3 weeks per participant

    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.

  2. Cue-provoked Cravings

    Time frame: 3 weeks per participant

    Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"

Secondary outcomes

  1. Smoking Topography - Number of Puffs on a Cigarette

    Time frame: 3 weeks per participant

    # Puffs = total number of puffs taken at Assessment Session.

  2. A Measure of the Subjective Expected Value of a Cigarette

    Time frame: 3 weeks per participant

    The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 5, 2008
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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