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Varenicline + Guanfacine for Smoking Cessation

Phase 2

Recruiting

Led By Sherry McKee, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18+

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50 minutes

Awards & highlights

Study Summary

This trial will study stress-induced smoking behavior and reinforcement, as well as the clinical outcomes of a 12-week treatment.

Who is the study for?

This trial is for adults who've smoked 10+ cigarettes daily for the past year, have a CO level >10 ppm, are motivated to quit smoking, and can commit to the study duration. They must be stable residents with transport and no plans to move soon. Excluded are those with significant medical conditions, substance use disorders (except mild alcohol/tobacco), recent psychoactive drug use, severe mental illness or ADHD.Check my eligibility

What is being tested?

The study tests combining Varenicline and Guanfacine ER to help people stop smoking. It includes a lab phase assessing stress-related smoking behavior followed by a 12-week treatment phase for clinical outcomes.See study design

What are the potential side effects?

Potential side effects of Varenicline may include nausea, sleep disturbances, headaches, and unusual dreams. Guanfacine ER could cause drowsiness, low blood pressure, dry mouth or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 50 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~50 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Latency

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Depression

21%

Agitation

21%

Headache

14%

Allergies

14%

Heartburn

14%

Cold

14%

Back Pain

Cellulitis

Sinusitis

Stomach Pain

Panic

Angina

Aggression

Palpitations

Rash

Confusion

Dizziness

Fatigue

Leg Spasms

Increased Blood Pressure

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Varenicline + Guanfacine ERExperimental Treatment2 Interventions

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.

Group II: VareniclineActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline

2011

Completed Phase 4

~4170

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,209 Total Patients Enrolled

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,073 Total Patients Enrolled

Sherry McKee, PhDPrincipal Investigator - Yale University

Yale University

5 Previous Clinical Trials

296 Total Patients Enrolled

Media Library

Guanfacine ER (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04198116 — Phase 2

Smoking Cessation Research Study Groups: Varenicline + Guanfacine ER, Varenicline

Smoking Cessation Clinical Trial 2023: Guanfacine ER Highlights & Side Effects. Trial Name: NCT04198116 — Phase 2

Guanfacine ER (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04198116 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Varenicline government rating?

"Varenicline is considered to be a 2 in terms of safety. While there is some evidence that suggests it is safe, none of the data points to it being an effective medication."

Answered by AI

What condition does Varenicline help alleviate the most?

"Varenicline is a medication used to treat common conditions like Attention Deficit Hyperactivity Disorder (ADHD), hypertensive disease, and migraine headaches. It can also help people quit smoking cigarettes."

Answered by AI

Are there still positions available for patients in this trial?

"This clinical trial, as reported on clinicaltrials.gov, is presently searching for candidates. The study was initially posted on 11/1/2020 and was most recently updated on 1/31/2022."

Answered by AI

Are there any other relevant research projects that have used Varenicline?

"At the moment, there are 39 Varenicline studies still ongoing with 6 of those in Phase 3 clinical trials. Many of these investigations into Varenicline are based out of Boston, Massachusetts; however, there are a total 153 locations running trials for Varenicline."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining Varenicline and Guanfacine for Smoking Cessation

Sherry McKee 2020. "Combining Varenicline and Guanfacine for Smoking Cessation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04198116.

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