Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Tobacco Dependence Clinical Trial

Official title:

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747643
• Other study ID #: MCC-15444
• Secondary ID: 106842
• Status: Completed
• Phase: N/A
• First received: September 4, 2008
• Last updated: November 21, 2013
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2011
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

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

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Smoking Topography - Number of Puffs on a Cigarette	# Puffs = total number of puffs taken at Assessment Session.	3 weeks per participant	No
Secondary	A Measure of the Subjective Expected Value of a Cigarette	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).	3 weeks per participant	No

External Links

•   Abstract: Varenicline Effects on Craving , Cue Reactivity and Smoking Reward
•   Moffitt Cancer Center Clinical Trials website