Smoking Cessation Medications for Quitting Smoking

Overseen By Lisa Coles

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Medical University of South Carolina

Must not be taking: Smoking cessation medications

Disqualifiers: Pregnancy, Suicidal ideation, Hallucinations, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

652 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample. Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study. The study lasts for six months, and will involve six total surveys. In addition, investigators ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to take a pregnancy test if required.

has a primary care doctor and has seen that doctor at least once in past year

You want to quit smoking in the future (rated 2 or higher on a scale of 1 to 10).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week sample of varenicline or nicotine replacement therapy, or no intervention

4 weeks

Remote participation with mailed samples

Follow-up

Participants are monitored for smoking cessation outcomes and medication use

22 weeks

6 surveys and daily diaries for the first 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Replacement Therapy (NRT)
• Varenicline 0.5 MG

Trial Overview 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.

How Is the Trial Designed?

Group I: Varenicline (.5mg BID) Experimental Treatment 1 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 Control 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+