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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 below
Select...
I am between 18 and 75 years old.

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

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 • NCT04011280
50%
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
2,976 Previous Clinical Trials
1,789,304 Total Patients Enrolled
PfizerIndustry Sponsor
4,575 Previous Clinical Trials
10,922,897 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially be enrolled in this experiment?

"This clinical trial mandates that the participants must possess an allergy and be between 18-75 years old. This investigation will include a total of 204 individuals."

Answered by AI

What is the current enrollment capacity of this clinical trial?

"This medical trial is not seeking participants at this time. It was initially listed on December 14th 2015, with the last update being made on June 15th 2022. If you are interested in similar studies, there are currently 278 clinical trials available for hypersensitivity and 87 options recruiting patients to test Varenicline's efficacy."

Answered by AI

Has recruitment for this medical trial been opened to the public?

"As reported on clinicaltrials.gov, this medical trial is no longer admitting participants. It was first posted to the platform in December 2015 and last updated June 15th 2022; however, there are 365 other trials that are currently welcoming prospective patients."

Answered by AI

Has the Food and Drug Administration given its blessing to Varenicline?

"Our assessment of Varenicline's safety is 3 out of a possible 3, as this medication has been approved and cleared for use in Phase 4 trials."

Answered by AI

Is this investigation open to volunteers who are of legal age?

"This particular research requires that enrollees are between 18 and 75 years of age. 87 experiments have been conducted on individuals below the legal age, while 246 studies were completed with seniors over 65."

Answered by AI

To what extent have other scientific experiments explored the effects of Varenicline?

"Currently, 87 experiments into Varenicline are in progress with 7 of them at the advanced Phase 3. Most studies occur in Green Bay, Wisconsin though there are 259 locations across America participating."

Answered by AI

What conditions is Varenicline regularly employed to ameliorate?

"Varenicline is a medication that can be prescribed to address smoke, ocular desiccative ailments, and nicotine-related issues."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Nothing else has worked.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Reward Sensitivity and Pharmacotherapy for Smoking Cessation
2015. "Reward Sensitivity and Pharmacotherapy for Smoking Cessation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02162849.
All > Penicillin Allergy > Smoking Cessation
~0 spots leftby Jun 2024
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