Cigarette Smoking, Smoking, Smoking Cessation, Tobacco Smoking
Conditions
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.
Interventions
varenicline comes in bottles of 56 - 0.5 mg pills
DRUGNicotine Replacement Therapy (NRT)
28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | At six-month follow up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Smoking | At the week 4 and week 26 follow up follow up | 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 |
| Any Quit Attempts | From study enrollment through end of six-month follow up (cumulative percent over six months) | 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 |
| Use of Smoking Cessation Medication | At 4 and 24 week follow-up | Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 11.4 |
| Race/Ethnicity, Customized Black or African American | 9.3 Percent |
| Race/Ethnicity, Customized Multiracial | 1.6 Percent |
| Race/Ethnicity, Customized Other | 1.9 Percent |
| Race/Ethnicity, Customized White | 85.3 Percent |
| Region of Enrollment United States | 172 participants |
| Sex/Gender, Customized Percent Female | 66.0 Percentage of Particpants |
| Sex/Gender, Customized Percent Male | 36.6 Percentage of Particpants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 318 | 0 / 172 | 0 / 161 |
| other Total, other adverse events | 222 / 318 | 95 / 172 | 69 / 161 |
| serious Total, serious adverse events | 0 / 318 | 0 / 172 | 0 / 161 |
Outcome results
None listed