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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 moreSide 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
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
2,966 Previous Clinical Trials
1,804,150 Total Patients Enrolled
10 Trials studying Tobacco Use Disorder
3,814 Patients Enrolled for Tobacco Use Disorder
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,522 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,199 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Varenicline been studied previously in any other research endeavors?
"At present, the number of ongoing studies for Varenicline is 87 with 7 in Phase 3. Most trials are based out of Green Bay, Wisconsin but various other medical centres across 259 locations have clinical trial activity for this drug."
Answered by AI
Has Varenicline been granted an endorsement from the FDA?
"There is a wealth of clinical evidence in support of Varenicline's safety, leading to it being assigned a 3 on the 1-3 scale."
Answered by AI
Are there any available slots to participate in this medical experiment?
"Per data hosted on clinicaltrials.gov, this particular experiment is no longer recruiting participants as it was last updated in July of 2022 and its opening date was May 14th 2015. Notwithstanding, 203 other trials are presently looking for enrollees."
Answered by AI
How many individuals have been accepted to participate in this clinical trial?
"This clinical trial is not presently open to new candidates. It was first posted on May 14th 2015 and last amended on July 18th 2022. Other studies recruiting patients with tobacco dependence include 116 active trials, while 87 studies seek participants for Varenicline research."
Answered by AI
What criteria must be met in order to qualify for this clinical trial?
"Inclusion criteria for this medical research includes tobacco addiction and being aged between 18-75. A total of 631 participants will be accepted into the trial."
Answered by AI
Will elderly individuals aged 75 and over be included in the clinical trial?
"The age requirements for this trial are between 18 - 75 years old. For those younger than 18, there are 8 suitable clinical trials and 151 options for individuals over 65."
Answered by AI
What is the primary malady that Varenicline has been proven to alleviate?
"Varenicline provides an effective remedy for smoke, dry eye syndromes and nicotine related ailments."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I finally reached the decision to stop smoking.
PatientReceived no prior treatments
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