Testing Different Smoking Cessation Interventions for the Promotion of Smoking Cessation
This trial investigates different stop-smoking (smoking cessation) interventions in helping patients who smoke cigarettes quit smoking. This study compares the usage of intensive treatment, consisting of multiple cessation counseling sessions and nicotine replacement therapy, to the standard of care, consisting of a referral to a tobacco quit-line, a starter kit of nicotine replacement therapy, and one cessation counseling session. Comparing different combinations of these interventions may help researchers identify which of them work best in enhancing access to and promoting smoking cessation treatment.
Inclusion Criteria
- STUDY PARTICIPATION: On smoking registry at a participating clinic
- STUDY PARTICIPATION: Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
- STUDY PARTICIPATION: Able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent)
- STUDY PARTICIPATION: Able to speak and read English
- ACCESS TO INTENSIVE TREATMENT (RANDOMIZATION ON 4TH FACTOR): Smoke at least 5 cigarettes per day on average for at least 6 months at enrollment
- ACCESS TO INTENSIVE TREATMENT (RANDOMIZATION ON 4TH FACTOR): Ability to meet screening criteria for one or both of the enhanced medication regimens, varenicline and/or combination NRT
Exclusion Criteria
- STUDY PARTICIPATION: Opted out of recruitment at the most recent clinic visit, or by patient-initiated contact
- STUDY PARTICIPATION: Willing to quit smoking within the next 30 days at recruitment call (these patients are referred for treatment or invited to be in a cessation study Institutional Review Board [IRB] # 2019-0054)
- STUDY PARTICIPATION: Activated healthcare power of attorney or cognitive impairment that would preclude informed consent
- ACCESS TO INTENSIVE TREATMENT (RANDOMIZATION ON 4TH FACTOR): Among women with childbearing potential: pregnancy, breastfeeding, or unwillingness to use an approved method of birth control (these include: abstinence, condoms, diaphragm, birth control pills or injectable contraceptive [e.g., Depo-Provera], intrauterine device [IUD], hysterectomy, tubal ligation, sterilization, vasectomy, or being more than 2 years post-menopausal) while receiving study medication. This will be assessed via self-report at the time a participant requests intensive treatment, and via tobacco care manager chart review at the time a request is sent to the primary care provider to review patient eligibility for varenicline and/or combination NRT. If a tobacco care manager sees that a patient is currently pregnant, s/he/they will not place the order
- ACCESS TO INTENSIVE TREATMENT (RANDOMIZATION ON 4TH FACTOR): Contraindications to both varenicline and nicotine patch and mini-lozenge. To be excluded, a person would have to have a contraindication in both varenicline and nicotine patch and mini-lozenge * Contraindication: Severe renal disease (varenicline) * Contraindication: Allergic or severe adverse reaction to varenicline (varenicline) * Contraindication: Allergic or severe adverse reaction to nicotine patch (nicotine patch and mini-lozenge) * Contraindication: Allergic or severe adverse reaction to nicotine lozenges or mini-lozenges (nicotine patch and mini-lozenge) * Contraindication: Suicide attempt in past 10 years (varenicline and nicotine patch and mini-lozenge) * Contraindication: Current treatment for schizophrenia or a psychotic disorder (varenicline and nicotine patch and mini-lozenge)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04199117.
PRIMARY OBJECTIVES:
I. To create an optimized reach intervention package by identifying intervention components that increase cessation treatment reach especially well, at low cost, at 1-year follow-up.
II. To estimate the main and interactive effects of the intervention components on cumulative treatment reach over 2 years of treatment access.
SECONDARY OBJECTIVES:
I. To estimate the main and interactive effects of intervention components on abstinence at 2-year follow-up.
II. To identify the degree to which intervention component effects on 2-year abstinence are mediated by increases in cessation treatment reach.
III. To assess the cost-effectiveness of intervention components in promoting reach and abstinence.
IV. To identify patient and clinic moderators of intervention component effects on reach and abstinence.
OUTLINE: Patients undergo biochemical testing via breath carbon monoxide (CO) test and/or collection of urine and/or saliva samples at 12 and 24 months post-enrollment. Patients also participate in interviews regarding smoking and quitting at 6, 12, 18, and 24 months post-enrollment. Patients who meet initial eligibility for intensive treatment are randomized to 1 of 16 conditions. Patients who do not meet initial eligibility (e.g. those with a history of severe renal and allergic reaction to nicotine-replacement therapy [NRT]) are randomized to 1 of the first 8 conditions.
CONDITION 1: Patients receive generic non-tailored letters noting available treatments and how to access them twice yearly (at enrollment and at 6, 12, 18, and 22 months). Patients undergo standard of care cessation treatment consisting of a referral to the primary care provider and a cessation counseling call with a trained quit coach over 20 minutes. Beginning 7 days prior to the target quit date, patients may also receive varenicline orally (PO) once daily (QD) on days 1-3, PO twice daily (BID) on days 4-7, then PO BID until 11 weeks post-target quit date per physician discretion. Starting on the quit date, patients may receive nicotine patches or nicotine mini-lozenges for 2 weeks per physician discretion.
CONDITION 2: Patients receive monetary incentives to spur treatment initiation up to 4 times (twice yearly). Patients receive generic non-tailored letters as in Condition 1. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 3: Patients receive tailored letters based on sex, age, assigned primary care provider, and assigned clinic with personalized pictures and messages promoting the use of available interventions. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 4: Patients receive monetary incentives to spur treatment initiation. Patients receive tailored letters as in Condition 3. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 5: Patients receive generic non-tailored letters as in Condition 1. Patients also communicate via phone with a tobacco care manager over 10-15 minutes within 2 weeks of enrollment and at 5, 10, 16, and 22 months post-enrollment about treatment options, ways to initiate treatment, and seek care manager support. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 6: Patients receive monetary incentives to spur treatment initiation. Patients receive generic non-tailored letters as in Condition 1. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 7: Patients receive tailored letters as in Condition 3. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 8: Patients receive monetary incentives to spur treatment initiation. Patients receive tailored letters as in Condition 3. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo standard of care cessation treatment and receive varenicline, nicotine patches, or nicotine mini-lozenges as in Condition 1.
CONDITION 9: Patients receive generic non-tailored letters as in Condition 1. Patients undergo intensive treatment consisting of phone counseling sessions over 15 minutes each at 1 week before their quit day, on the day after their quit day, and at 1 week after their quit day. Beginning 7 days prior to the target quit date, patients may also receive varenicline PO QD on days 1-3, PO BID on days 4-7, then PO BID until 11 weeks post-target quit date per physician discretion. Starting on the quit date, patients may receive nicotine patches and nicotine mini-lozenges for 12 weeks per physician discretion.
CONDITION 10: Patients receive monetary incentives to spur treatment initiation. Patients receive generic non-tailored letters as in Condition 1. Patients undergo intensive treatment as well as varenicline and/or nicotine patches and nicotine mini-lozenges as in Condition 9.
CONDITION 11: Patients receive tailored letters as in Condition 3. Patients undergo intensive treatment as in Condition 9.
CONDITION 12: Patients receive monetary incentives to spur treatment initiation. Patients receive tailored letters as in Condition 3. Patients undergo intensive treatment as in Condition 9.
CONDITION 13: Patients receive generic non-tailored letters as in Condition 1. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo intensive treatment as in Condition 9.
CONDITION 14: Patients receive monetary incentives to spur treatment initiation. Patients receive generic non-tailored letters as in Condition 1. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo intensive treatment as in Condition 9.
CONDITION 15: Patients receive tailored letters as in Condition 3. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo intensive treatment as in Condition 9.
CONDITION 16: Patients receive monetary incentives to spur treatment initiation. Patients receive tailored letters as in Condition 3. Patients also communicate via phone with a tobacco care manager as in Condition 5. Patients undergo intensive treatment as in Condition 9.
After completion of study, patients with a target quit day or those who set a quit day during the study are followed up at 3, 12, and 26 weeks after the quit day.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorMichael C. Fiore
- Primary IDUW20070
- Secondary IDsNCI-2020-06638, 2019-0939
- ClinicalTrials.gov IDNCT04199117