Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

NCT00747643 | Completed Results DMC

• 2 other identifiers: MCC-15444106842
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Tonic Craving Score (QSU) Based on Self Reports

  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.

  3 weeks per participant

• Cue-provoked Cravings

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

  3 weeks per participant

Secondary Outcomes (2)

• Smoking Topography - Number of Puffs on a Cigarette

  3 weeks per participant

• A Measure of the Subjective Expected Value of a Cigarette

  3 weeks per participant

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

varenicline DRUG

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

Also known as: Chantix™

Varenicline

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Smoke at least 15 cigarettes daily
• Expired-air carbon monoxide (CO) \> 10 ppm
• Medically eligible to receive Varenicline.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Thomas H. Brandon, Ph.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

thomas.brandon@moffitt.org

813-745-1750

Study Officials

• Thomas Brandon, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 16, 2013
• Results First Posted: November 29, 2011

Record last verified: 2011-10

Locations

US (1)