Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00747643
First received: September 4, 2008
Last updated: November 21, 2013
Last verified: October 2011
  Purpose

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.


Condition Intervention
Tobacco Dependence
Drug: varenicline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Tonic Craving Score (QSU) Based on Self Reports [ Time Frame: 3 weeks per participant ] [ Designated as safety issue: No ]
    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.

  • Cue-provoked Cravings [ Time Frame: 3 weeks per participant ] [ Designated as safety issue: No ]
    Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?"


Secondary Outcome Measures:
  • Smoking Topography - Number of Puffs on a Cigarette [ Time Frame: 3 weeks per participant ] [ Designated as safety issue: No ]
    # Puffs = total number of puffs taken at Assessment Session.

  • A Measure of the Subjective Expected Value of a Cigarette [ Time Frame: 3 weeks per participant ] [ Designated as safety issue: No ]
    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).


Enrollment: 163
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: varenicline
Participants in this group received varenicline according to the schedule in the Arm Description.
Other Name: Chantix™
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.
Drug: placebo
Participants in this group received a placebo and did not receive any active medication according to the schedule in the Arm Description.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747643

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Pfizer
Investigators
Principal Investigator: Thomas Brandon, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00747643     History of Changes
Other Study ID Numbers: MCC-15444, 106842
Study First Received: September 4, 2008
Results First Received: July 27, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
tobacco
nicotine
smoking
reward
reinforcement
craving
cues
conditioned stimuli
cue reactivity

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014