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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:
Select...
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 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
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
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
Placebo Patch
2011
Completed Phase 4
~4500
Nicotine Patch
2011
Completed Phase 4
~10480
Questionnaires
2013
Completed Phase 2
~4280
Placebo Tablet
2016
Completed Phase 3
~3600

Find a Location

Who is running the clinical trial?

NAL PHARMAOTHER
M.D. Anderson Cancer CenterLead Sponsor
3,053 Previous Clinical Trials
1,798,545 Total Patients Enrolled
PfizerIndustry Sponsor
4,642 Previous Clinical Trials
17,742,859 Total Patients Enrolled

Media Library

Nicotine Patch (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02162849 — Phase 4
Quitting Smoking Research Study Groups: Varenicline + Placebo Patch, Nicotine Patch + Placebo Tablet
Quitting Smoking Clinical Trial 2023: Nicotine Patch Highlights & Side Effects. Trial Name: NCT02162849 — Phase 4
Nicotine Patch (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02162849 — Phase 4
~13 spots leftby Jun 2025
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