NCT02501265 - Adaptive Pharmacotherapy for Smoking Cessation | Biotech Hunter

Enrollment

188

Participants

Timeline

Start Date

June 6, 2017

Primary Completion Date

July 30, 2020

Study Completion Date

May 12, 2021

Conditions

Nicotine Dependence

Interventions

BEHAVIORAL

Varenicline Standard Protocol

"4 weeks pre-TQD: Start Placebo Varenicline~1 week prior to TQD: Switch to Active Varenicline~1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD"

BEHAVIORAL

Nicotine Patch Standard Protocol

"4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch~1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD"

DRUG

Varenicline Adaptive Protocol

"VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by \> 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD~VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by \> 50%~1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD"

DRUG

Nicotine Adaptive Protocol

"NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by \> 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD~NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by \> 50%~1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD"

Trial Locations (1)

27705

Duke Center for Smoking Cessation, Durham