Smoking Cessation Medications for Quitting Smoking

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Trial Summary

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.

Research Team

Eligibility Criteria

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).

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Treatment Details

Interventions

Nicotine Replacement Therapy (NRT) (Nicotine Replacement Therapy)
Varenicline 0.5 MG (Partial Nicotine Agonist)

Trial OverviewThis 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.

Participant Groups

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