Combining Varenicline and Guanfacine for Smoking Cessation

NCT04198116 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

Varenicline

Varenicline 2mg/day

DRUG

Guanfacine ER

Guanfacine Extended Release (6mg/day ER)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Sherry McKee, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198116 on ClinicalTrials.gov