Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

NCT00747643

Last updated date
Study Location
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
Official Title  ICMJE Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2011)
163
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
126
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747643
Other Study ID Numbers  ICMJE MCC-15444
106842 ( Other Identifier: USF IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Thomas Brandon, Ph.D.H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP