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Smoking Cessation Medications for Quitting Smoking
Phase 1 & 2
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
no reports of hallucinations
no diagnosis of schizophrenia or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment through end of six-month follow up
Awards & highlights
Study Summary
This trial is testing whether giving smokers free samples of smoking cessation medications, either varenicline or nicotine replacement products, is an effective way to help them quit.
Who is the study for?
The STARS study is for adult smokers who have smoked more than a year, smoke at least 5 cigarettes daily, and are somewhat interested in quitting. They must have seen their primary care doctor within the past year, not be pregnant or breastfeeding, and should not have a history of seizures or severe mental health issues like schizophrenia.Check my eligibility
What is being tested?
This trial tests if one-time samples of smoking cessation medications (varenicline or nicotine patches/lozenges) sent remotely can help smokers quit. Participants will randomly receive varenicline, nicotine products, or no treatment. The study involves surveys over six months and daily diaries for the first month.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep disturbances, mood changes, and headaches. Nicotine replacement therapy can lead to skin irritation from patches or mouth issues from lozenges; both might cause dizziness or racing heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not experienced hallucinations.
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I have not been diagnosed with schizophrenia or bipolar disorder.
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I have never had seizures, heart, or kidney diseases.
Select...
I have not had thoughts of suicide in the last month and have never attempted suicide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study enrollment through end of six-month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment through end of six-month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-day Quit Attempts
Secondary outcome measures
Any Quit Attempts
Reduction in Smoking
Use of Smoking Cessation Medication
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Varenicline (.5mg BID)Experimental Treatment1 Intervention
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience.
Group II: Nicotine Replacement Therapy (NRT)Active Control1 Intervention
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish.
Group III: Control GroupActive Control1 Intervention
Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline 0.5 MG
2018
Completed Early Phase 1
~100
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,393,987 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to take a pregnancy test if required.You want to quit smoking in the future (rated 2 or higher on a scale of 1 to 10).I have not experienced hallucinations.I am 18 years old or older.You smoke more than 5 cigarettes per day.You have a primary care doctor and have seen that doctor at least once in the past year.You smoke cigarettes every day for at least 25 days in the past month.I am somewhat interested in quitting smoking.I have not been diagnosed with schizophrenia or bipolar disorder.I am 18 years old or older.I have never had seizures, heart, or kidney diseases.I have not had thoughts of suicide in the last month and have never attempted suicide.You are not taking any medicine to help you stop smoking.You have smoked for more than one year.You smoke at least 5 cigarettes per day.You smoked on most days (25 or more days) in the past month.You have smoked cigarettes for more than 1 year.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline (.5mg BID)
- Group 2: Nicotine Replacement Therapy (NRT)
- Group 3: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How is Varenicline 0.5 MG typically employed in therapeutic settings?
"Varenicline 0.5 MG has been clinically proven to be a successful treatment option for smoke, dry eye syndromes, and nicotine-related issues."
Answered by AI
Are applicants currently being accepted for this medical trial?
"Per clinicaltrials.gov, this project is actively sourcing volunteers since it was first launched on February 8th 2021 and last amended on March 8th 2022."
Answered by AI
What have earlier experiments revealed about Varenicline 0.5 MG?
"At present, 87 experiments involving Varenicline 0.5 MG are underway with 7 of them being in the Phase 3 stage. Green Bay, Wisconsin is a hub for this research; however, there are 259 different sites conducting trials on it across the country."
Answered by AI
What is the total number of participants being accepted into this research study?
"Verified. The clinicaltrials.gov website confirms that this research is actively enrolling participants, with the initial posting of the trial made on February 8th 2021 and its most recent update occurring on March 8th 2022. This medical investigation seeks to recruit 648 individuals from one location."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Medical University of South Carolina
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Money and to stop smoking. Looks interesting and I need money. I want to quit smoking permanently.
PatientReceived no prior treatments
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