A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00741884

Enrollment

Registered

2008-08-26

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.

Interventions

DRUGVarenicline Controlled Release 1.2 mg

Varenicline CR tablet 1.2 mg BID for 7 weeks

DRUGVarenicline Controlled Release 1.8 mg

Varenicline CR tablet 1.8 mg BID for 7 weeks

DRUGVarenicline Controlled Release 2.4 mg

Varenicline CR tablet 2.4 mg BID for 7 weeks

DRUGVarenicline Immediate Release 1 mg

Varenicline IR tablet 1 mg BID for 7 weeks

DRUGPlacebo

Placebo BID for 7 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking. * Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. * Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria

* Subjects with clinically significant cardiovascular disease in the past 6 months. * Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months. * Subjects having active suicidal ideation or behavior identified at Screen or Baseline. * Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.

Design outcomes

Primary

Measure	Time frame
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed	7 weeks

Secondary

Measure	Time frame
7- day point prevalence of non-smoking at week 7	7 days
Scores on the Minnesota Nicotine Withdrawal Scale subscales	7 weeks
Scores on the Modified Cigarette Evaluation Questionaire subscales	7 weeks
PK analysis	7 weeks
Safety Assessments: adverse events, C-SSRs, vital signs, body weight	7 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026