CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 167 enrolled / 167 target
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 2mgfrom 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/NCT04198116
NCT04198116Phase 2CompletedHigh Momentum (2.5/mo)Completion was 14mo ago
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Combining Varenicline and Guanfacine for Smoking Cessation

Yale University·interventional·Posted Dec 13, 2019·Updated Jun 9, 2026

In Brief

A Phase 2 clinical trial evaluating Varenicline and Guanfacine ER for Smoking Cessation. Completed, enrolled 167 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

The novel design of this study combines a laboratory paradigm to evaluate stress-induced smoking behavior and smoking-related reinforcement, followed by a 12-week treatment phase to evaluate clinical outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 13, 2019
Enrollment StartNov 1, 2020
Primary CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.6 years ago

Arms & Interventions

Varenicline + Guanfacine ERexperimental

Varenicline (2mg/day) + Guanfacine extended release (6mg/day ER). Varenicline (2mg/day) administered orally twice a day at 8:00 AM and 8:00 PM while titrating to full dose. Titration schedule: Days 1-9 0mg/day; 0mg/dose, Days 10-12 0.5mg/day; 0.5mg/dose 8:00 PM, Days 13-15 1mg/day; 0.5mg/dose, Days 16-21 2mg/day; 1mg/dose. Guanfacine ER (6mg/day) administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Days 1-3 1mg/day; 0.5mg/dose, Days 4-6 2mg/day; 1mg/dose, Days 7-9 3mg/day; 1.5mg/dose, Days 10-12 4mg/day; 2mg/dose; Days 13-15 5mg/day; 2.5mg/dose and Days 16-23 6mg/day; 3mg/dose. Once at steady state, administration is orally once per day at 8:00 PM for both medications.

Drug: VareniclineDrug: Guanfacine ER
Vareniclineactive_comparator

Varenicline (2mg/day). Varenicline (2mg/day) administered orally twice a day at 8:00 AM and 8:00 PM while titrating to full dose. Titration schedule: Days 1-9 0mg/day; 0mg/dose, Days 10-12 0.5mg/day; 0.5mg/dose 8:00 PM, Days 13-15 1mg/day; 0.5mg/dose, Days 16-21 2mg/day; 1mg/dose. Once at steady state, administration is orally once per day at 8:00 PM.

Drug: Varenicline

Interventions

Vareniclinedrug

Varenicline 2mg/day

Guanfacine ERdrug

Guanfacine Extended Release (6mg/day ER)