Clinical trial NCT04525755: STARS (Smoking Treatment And Remote Sampling) Study
Official title: A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking
Smoking Cessation
Tobacco Smoking
Cigarette Smoking
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. 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. 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.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Eligibility criteria include:

1. age 18+;
2. daily smoker (25+ days per previous month);
3. smoking 5+ cigarettes/day;
4. smoking \> 1yr;
5. some interest in eventual quitting (\>2 on 10-point scale);
6. has a primary care doctor and has seen that doctor at least once in past year;
7. not currently pregnant, breastfeeding, or planning to become pregnant;
8. no suicidal ideation in past month, nor any lifetime suicide attempt;
9. no reports of hallucinations;
10. no reports of history of seizures; nor cardiac/renal disease
11. own a smartphone or have regular (daily) access/use of email
12. if female, willing to take a pregnancy test
13. not currently taking any medications to help quit smoking
14. no diagnosis of schizophrenia or bipolar disorder
15. no members of the same household currently enrolled in the study

Primary outcomes:
measure: 7-day Quit Attempts
timeFrame: From study enrollment through end of six-month follow up
Secondary outcomes:
measure: Reduction in Smoking
timeFrame: At the week 4 follow up and week 26 follow up.
measure: Any Quit Attempts
timeFrame: From study enrollment through end of six-month follow up
measure: Use of Smoking Cessation Medication
timeFrame: From study enrollment through end of six-month follow up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: