A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

Phase 4

Completed

Conditions: Smoking Cessation

Interventions: Drug: Varenicline Tartrate
Drug: Placebo

Registration Number: NCT01370356

Lead Sponsor: Pfizer

Brief Summary: This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1510

Inclusion Criteria

Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) >10 ppm at screening.
Subjects with mild to moderate depression or anxiety may be included if their condition is stable.

Exclusion Criteria

Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
Subjects with severe depression or anxiety.
Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline Tartrate	Varenicline Tartrate	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking	Week 15 - 24	Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With CO Confirmed 4-Week CA From Smoking	Week 21 - 24	Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Percentage of Participants With CO Confirmed Long Term CA From Smoking	Weeks 21 - 52	Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation	Week 12, 24, and 52	The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant's smoking status and other nicotine use was evaluated based on the "last 7 days" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 7 days?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?") and whose expired CO \< 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm).
Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation	Week 52	The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant's smoking status and other nicotine use was evaluated based on the "last 4 weeks" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?") and whose expired CO \< 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm).

Trial Locations

Locations (63): Pharmacology Research Institute
🇺🇸
Newport Beach, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States
Central Kentucky Research Associates, Inc.
🇺🇸
Lexington, Kentucky, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
The Center for Pharmaceutical Research, P.C.
🇺🇸
Kansas City, Missouri, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
CRI Worldwide, LLC
🇺🇸
Marlton, New Jersey, United States
Clinical Research Integrity(CRI) Worldwide, LLC
🇺🇸
Willingboro, New Jersey, United States
Central New York Clinical Research
🇺🇸
Manlius, New York, United States
FutureSearch Clinical Trials, L.P.
🇺🇸
Austin, Texas, United States
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Pharmacology Research Institute
🇺🇸Newport Beach, California, United States