Combining Varenicline and Bupropion for Smoking Cessation

PHASE3CompletedINTERVENTIONAL
Enrollment

641

Participants

Timeline

Start Date

May 17, 2010

Primary Completion Date

May 31, 2020

Study Completion Date

September 9, 2021

Conditions
Smoking Cessation
Interventions
DRUG

Varenicline

On Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses).

DRUG

Bupropion

On Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses).

OTHER

Placebo

On Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day.

BEHAVIORAL

Counseling/Phone Calls

Brief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

Pfizer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER