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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continuous Nicotine Abstinence
Secondary outcome measures
Continuous and Prolonged Nicotine Abstinence
Side effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Depression
21%
Agitation
21%
Headache
14%
Allergies
14%
Heartburn
14%
Cold
14%
Back Pain
7%
Cellulitis
7%
Sinusitis
7%
Stomach Pain
7%
Panic
7%
Angina
7%
Aggression
7%
Palpitations
7%
Rash
7%
Confusion
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Increased Blood Pressure
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
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
Placebo Tablet
2016
Completed Phase 3
~3690
Placebo Patch
2011
Completed Phase 4
~4500
Counseling Sessions
2006
Completed Phase 2
~460
Nicotine Patch
2011
Completed Phase 4
~10480
Varenicline
2011
Completed Phase 4
~4170
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
NAL PHARMAOTHER
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,310 Total Patients Enrolled
PfizerIndustry Sponsor
4,580 Previous Clinical Trials
14,633,999 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to use nicotine substitutes or treatments to quit smoking soon.I have not had a serious or unstable illness in the last 3 months.I am not pregnant, post-menopausal for two years, or have had surgery to prevent pregnancy.I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.I have not tested positive for illegal drugs or misuse of prescription drugs.I am willing to adjust my hairstyle or remove a wig for the study.I am between 18 and 75 years old.I have had heart problems or abnormal heart rhythms in the last 3 months.I have a history of seizures, brain illness, or head injury that might affect EEG results.I have not been hospitalized for psychiatric reasons in the last year.I have severe kidney or liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline + Placebo Patch
- Group 2: Nicotine Patch + Placebo Tablet
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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