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An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Roswell Park Comprehensive Cancer Center logo

Roswell Park Comprehensive Cancer Center

Status and phase

Completed
Phase 2

Conditions

Smoking Cessation

Treatments

Drug: varenicline
Drug: placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00835900
I 136208
Pfizer IIR-GA30523

Details and patient eligibility

About

The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

Full description

This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • currently smoking at least 15 cigarettes daily
  • in good health
  • able to read and speak English fluently
  • have a home telephone and plan to reside in Western New York for 6 months
  • willing to make quit attempt
  • signed informed consent
  • who planned quit attempt.

Exclusion criteria

  • serious medical condition
  • depression or mental health condition requiring treatment in the past year
  • history of panic disorder, psychosis, bipolar disorder
  • alcohol or drug abuse in the past year
  • use of tobacco products other than cigarettes
  • current use of other cessation pharmacotherapies
  • pregnancy/planned pregnancy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

varenicline
Experimental group
Description:
drug plus counseling.
Treatment:
Drug: varenicline
placebo
Active Comparator group
Description:
placebo plus counseling
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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