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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

Must not have

Suicidal, homicidal or evidence of current (past 6-month) severe mental illness such as schizophrenia or bipolar disorder

Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50 minutes

Awards & highlights

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.

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.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had severe mental health issues like schizophrenia or bipolar disorder in the last 6 months.

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I am not pregnant or nursing and use effective birth control or am surgically sterile/postmenopausal.

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I do not have any major health issues like heart problems, seizures, or liver disease.

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I am currently using smoking cessation aids or have used tobacco products in the last 30 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Latency

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Agitation

21%

Depression

21%

Headache

14%

Heartburn

14%

Allergies

14%

Cold

14%

Back Pain

Confusion

Aggression

Panic

Stomach Pain

Dizziness

Fatigue

Leg Spasms

Sinusitis

Angina

Increased Blood Pressure

Palpitations

Cellulitis

Rash

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 / 5Eligibility criteria met