STARS (Smoking Treatment And Remote Sampling) Study

Medical University of South Carolina652 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

652

Conditions

Smoking Smoking Cessation Tobacco Smoking

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Smoking Cessation

Percentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group

Time frame: At six-month follow up

Secondary Outcomes

Reduction in Smoking

Percentage of participants who have reduced their smoking by at least 50%, at both Week 4 and Week 26 follow-up, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group

Time frame: At the week 4 and week 26 follow up follow up

Any Quit Attempts

Any self-defined attempt and any 24-hr quit attempt to stop smoking cigarettes among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group

Time frame: From study enrollment through end of six-month follow up (cumulative percent over six months)

Use of Smoking Cessation Medication

Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group

Time frame: At 4 and 24 week follow-up