Status:

COMPLETED

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Collaborating Sponsors:

Pfizer

Conditions:

Tobacco Dependence

Eligibility:

All Genders

18-60 years

Phase:

NA

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...

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-repo...

Eligibility Criteria

Inclusion

  • 18-60 years of age
  • Smoke at least 15 cigarettes daily
  • Expired-air carbon monoxide (CO) \> 10 ppm
  • Medically eligible to receive Varenicline.

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

163 Patients enrolled

Trial Details

Trial ID

NCT00747643

Start Date

September 1 2008

End Date

August 1 2010

Last Update

December 16 2013

Active Locations (1)

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H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612