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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Smoking Cessation

Treatments

Drug: Placebo

Drug: Varenicline Tartrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01370356

REDUCE TO QUIT

A3051075

Details and patient eligibility

About

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.

Enrollment

1,510 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.