STARS (Smoking Treatment And Remote Sampling) Study

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cigarette Smoking

Tobacco Smoking

Smoking

Smoking Cessation

Treatments

Drug: Varenicline 0.5 MG

Drug: Nicotine Replacement Therapy (NRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04525755

Pro00098479

Details and patient eligibility

About

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.

Enrollment

652 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria include:

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

652 participants in 3 patient groups

Varenicline (.5mg BID)

Experimental group

Description:

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.

Treatment:

Drug: Varenicline 0.5 MG

Nicotine Replacement Therapy (NRT)

Active Comparator group

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. 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.

Treatment:

Drug: Nicotine Replacement Therapy (NRT)

Control Group

No Intervention group

Description:

Trial documents