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Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline + NRT for Smoking Cessation

Phase 4
Waitlist Available
Led By Paul Cinciripini
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
Be older than 18 years old
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial is comparing varenicline to nicotine replacement therapy to see if varenicline is more effective in helping patients quit smoking. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming.

Who is the study for?
This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, are interested in quitting, and can follow instructions in English. They must not use other tobacco products frequently or be on certain medications like smoking cessation drugs or some antidepressants. People with severe kidney or liver disease, uncontrolled high blood pressure, recent heart issues, or unstable psychiatric conditions cannot join.Check my eligibility
What is being tested?
The study compares the effectiveness of varenicline (a non-addictive nicotine-like drug) to nicotine replacement therapy (patches and lozenges) combined with counseling to help people quit smoking. It's a randomized pilot phase IV trial where participants are randomly assigned to either treatment without knowing which one they're getting.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep disturbances, headaches, and unusual dreams. Nicotine replacement can result in skin irritation from patches and mouth issues from lozenges. Both treatments might also trigger changes in taste or appetite.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe kidney or liver disease.
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I am not pregnant, breastfeeding, and if capable of childbearing, I use effective birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires
Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment
Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment
+5 more

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
43%
Dysgeusia
29%
Sleep Disturbances
29%
Depression
14%
Coronary Heart Disease
14%
Headache
14%
Hostility
14%
Vertigo
14%
Anxiety
14%
Flu
7%
Muscle Pain
7%
Diarrhea
7%
Nausea
7%
Intrusive Thoughts
7%
Stomach Pain
7%
Dizziness
7%
Hyperglycemia
7%
Increased Thirst
7%
Hallucination
7%
Mania
7%
Paranoia
7%
Suicidal Ideation
7%
Agitation
7%
Panic
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (varenicline and placebo)Experimental Treatment3 Interventions
Patients receive varenicline PO QD or BID, placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
Group II: Group II (placebo, nicotine patch and lozenge)Placebo Group4 Interventions
Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients that are abstinent at week 6 may continue treatment for an additional 6 weeks. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,793,648 Total Patients Enrolled
10 Trials studying Tobacco Use Disorder
3,814 Patients Enrolled for Tobacco Use Disorder
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,770 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,120 Patients Enrolled for Tobacco Use Disorder
Paul CinciripiniPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
2,390 Total Patients Enrolled

Media Library

Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02271919 — Phase 4
Tobacco Use Disorder Research Study Groups: Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge)
Tobacco Use Disorder Clinical Trial 2023: Varenicline Highlights & Side Effects. Trial Name: NCT02271919 — Phase 4
Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02271919 — Phase 4
~57 spots leftby Jun 2025