NCT04198116 is a Phase 2 clinical trial of Varenicline in Smoking Cessation, sponsored by Yale University.

Who is sponsoring NCT04198116?

NCT04198116 is sponsored by Yale University.

What drugs are being tested in NCT04198116?

Interventions in NCT04198116: Varenicline, Guanfacine ER.

What condition does NCT04198116 study?

NCT04198116 studies Smoking Cessation.

Is NCT04198116 still recruiting?

NCT04198116 is currently completed. Last updated 25 July 2025.

Last reviewed 2025-07-25 · How we verify

NCT04198116

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combining Varenicline and Guanfacine for Smoking Cessation

Completed Phase 2 Last updated 25 July 2025

What this trial tests

Phase 2 trial testing Varenicline in Smoking Cessation in 165 participants. Completed in 30 April 2025.

Timeline

1 November 2020

Primary endpoint
30 April 2025

30 April 2025

Quick facts

Lead sponsor	Yale University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	165
Start date	1 November 2020
Primary completion	30 April 2025
Estimated completion	30 April 2025
Sites	1 location across United States

Drugs / interventions tested

Varenicline (varenicline) — full drug profile →
Guanfacine ER

Conditions studied

Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Yale University

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Consideration of sex and gender differences in addiction medication response.
McKee SA, McRae-Clark AL. · · 2022 · cited 45× · PMID 35761351 · DOI 10.1186/s13293-022-00441-3

Verify or expand the search:

Other trials of Varenicline

Trials testing the same drug.

NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
NCT06854406 — A Study of Varenicline in the Treatment of Visceral Sensation · Phase 1 · completed
NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
NCT06029907 — Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. · Phase 4 · completed
NCT06218823 — Tobacco Treatment Comparison for Cancer Care · Phase 4 · completed

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients · Phase 1 · recruiting
NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer · NA · recruiting
NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors · NA · recruiting
NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04198116 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 25 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04198116.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing