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Nicotine Replacement Therapy

Varenicline + Nicotine Patch for Quitting Smoking

Phase 4

Waitlist Available

Led By Paul Cinciripini, PHD, MS, BS

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

Age: 18-75 years old

Be older than 18 years old

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing if varenicline or the nicotine patch can help people with different emotional and attention levels quit smoking.

Who is the study for?

Adults aged 18-75 who smoke at least 5 cigarettes daily, want to quit smoking, and can follow instructions in English. They must be the only participant from their household and have a reachable address and phone number. Excluded are those using other tobacco products frequently, enrolled in another cessation program, with uncontrolled hypertension or significant recent disease, certain psychiatric conditions or drug use.

What is being tested?

The study is testing whether varenicline (a medication) or nicotine patches help people with varying emotional and attention levels quit smoking. Participants will undergo saliva tests, counseling sessions, lab sessions, questionnaires and receive either the actual treatments or placebo versions.

What are the potential side effects?

Possible side effects of varenicline include nausea, sleep disturbances, mood changes while nicotine patches may cause skin irritation and dizziness. Placebos typically have no active ingredients but can lead to perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.

Select...

I have severe kidney or liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Continuous Nicotine Abstinence

Secondary study objectives

Continuous and Prolonged Nicotine Abstinence

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

Group I: Varenicline + Placebo PatchExperimental Treatment6 Interventions

Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1. Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Group II: Nicotine Patch + Placebo TabletExperimental Treatment6 Interventions

Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening. Starting on Day 8, and then every day after that, participant applies 1 nicotine patch. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline

2011

Completed Phase 4

~4170

Counseling Sessions

2006

Completed Phase 2

~460