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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.
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.
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:Select...
I have severe kidney or liver disease.
Select...
I am not pregnant, breastfeeding, and if capable of childbearing, I use effective birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSide effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
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
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
3,039 Previous Clinical Trials
1,799,070 Total Patients Enrolled
10 Trials studying Tobacco Use Disorder
3,814 Patients Enrolled for Tobacco Use Disorder
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,369 Total Patients Enrolled
95 Trials studying Tobacco Use Disorder
1,682,598 Patients Enrolled for Tobacco Use Disorder
Paul CinciripiniPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
2,390 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney or liver disease.I have not had a serious or unstable illness in the last 3 months.You have an address and telephone number where he/she may be reached.I am not pregnant, post-menopausal for two years, or have had surgery to prevent pregnancy.I have not had heart problems or strokes in the last 3 months.I am not pregnant, breastfeeding, and if capable of childbearing, I use effective birth control.I have not tested positive for restricted drugs or have a valid prescription.I plan to use nicotine substitutes or smoking cessation treatments soon.You live alone in your home.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (varenicline and placebo)
- Group 2: Group II (placebo, nicotine patch and lozenge)
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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