CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 188 enrolled
Drug / intervention
Varenicline Adaptive Protocol +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02501265
NCT02501265Phase 2Completed
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Randomized Controlled Smoking Cessation Trial on Adaptive Pharmacotherapy

Duke University·interventional·Posted Jul 17, 2015·Updated Aug 19, 2021

In Brief

A Phase 2 clinical trial evaluating Varenicline Standard Protocol, Nicotine Patch Standard Protocol, and 2 other interventions for Nicotine Dependence. Completed, enrolled 188 participants across 1 site.

Detailed Summary

The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the Nicotine Patch. The investigators hypothesize that participants allocated to adaptive therapy will show significantly higher biochemically confirmed 30-day continuous abstinence at 12 weeks post-Target Quit Day (TQD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), Pfizer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartJun 6, 2017
Primary CompletionJul 30, 2020
Study CompletionMay 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.0 years ago

Interventions

Varenicline Standard Protocolbehavioral

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

Nicotine Patch Standard Protocolbehavioral

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

Varenicline Adaptive Protocoldrug

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

Nicotine Adaptive Protocoldrug

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