Nicotine Replacement Therapy
Varenicline for Quitting Smoking
University of Texas MD Anderson Cancer Center, Houston, TX
Varenicline +7 morePhase 4Waitlist AvailableLed by Paul Cinciripini, PHD, MS, BSResearch Sponsored by M.D. Anderson Cancer CenterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Interested in treatment that might change smoking behavior
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
Study Summary
This trial is testing if varenicline or the nicotine patch can help people with different emotional and attention levels quit smoking.
Eligible Conditions
- Quitting Smoking
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are open to trying treatments that could help you quit smoking or reduce your smoking habits.
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 • NCT0401128043%
Dysgeusia
29%
Sleep Disturbances
29%
Depression
14%
Vertigo
14%
Headache
14%
Coronary Heart Disease
14%
Hostility
14%
Anxiety
14%
Flu
7%
Stomach Pain
7%
Dizziness
7%
Increased Thirst
7%
Hallucination
7%
Mania
7%
Paranoia
7%
Suicidal Ideation
7%
Diarrhea
7%
Nausea
7%
Muscle Pain
7%
Hyperglycemia
7%
Agitation
7%
Panic
7%
Intrusive Thoughts
7%
Syncope
7%
Increased Appetite
7%
Weight Gain
7%
Abscess
7%
Back Pain
7%
Leg Cramps
7%
Frequent Urination
7%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Varenicline
Low Dose Varenicline
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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
Counseling Sessions
2006
Completed Phase 2
~460
Varenicline
FDA approved
Nicotine
FDA approved
Placebo Patch
2011
Completed Phase 4
~4500
Placebo Tablet
2016
Completed Phase 3
~3330
Questionnaires
2013
Completed Phase 2
~3010
Find a site
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,887 Previous Clinical Trials
1,783,135 Total Patients Enrolled
NAL PHARMAOTHER
PfizerIndustry Sponsor
4,476 Previous Clinical Trials
30,364,496 Total Patients Enrolled
Paul Cinciripini, PHD, MS, BSPrincipal Investigator
M.D. Anderson Cancer Center2 Previous Clinical Trials
1,250 Total Patients Enrolled
Media Library
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