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Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline + NRT for Smoking Cessation

Phase 4

Waitlist Available

Led By Paul Cinciripini

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level

Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is comparing varenicline to nicotine replacement therapy to see if varenicline is more effective in helping patients quit smoking. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming.

Who is the study for?

This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, are interested in quitting, and can follow instructions in English. They must not use other tobacco products frequently or be on certain medications like smoking cessation drugs or some antidepressants. People with severe kidney or liver disease, uncontrolled high blood pressure, recent heart issues, or unstable psychiatric conditions cannot join.

What is being tested?

The study compares the effectiveness of varenicline (a non-addictive nicotine-like drug) to nicotine replacement therapy (patches and lozenges) combined with counseling to help people quit smoking. It's a randomized pilot phase IV trial where participants are randomly assigned to either treatment without knowing which one they're getting.

What are the potential side effects?

Varenicline may cause nausea, sleep disturbances, headaches, and unusual dreams. Nicotine replacement can result in skin irritation from patches and mouth issues from lozenges. Both treatments might also trigger changes in taste or appetite.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have severe kidney or liver disease.

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I am not pregnant, breastfeeding, and if capable of childbearing, I use effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires

Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment

Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment

+5 more

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group I (varenicline and placebo)Experimental Treatment3 Interventions

Patients receive varenicline PO QD or BID, placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

Group II: Group II (placebo, nicotine patch and lozenge)Placebo Group4 Interventions

Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline

2011

Completed Phase 4

~4170

0 / 2Eligibility criteria met