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Adaptive Smoking Cessation Treatment for the Prevention of Smoking Cessation Relapse, ADAPT to Quit Trial
Trial Status: active
This clinical trial studies how well switching to a different smoking cessation treatment (adaptive treatment) works in preventing a return to smoking (smoking cessation relapse). Smoking causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit, and there are a number of options to do so. Varenicline both reduces cravings for and decreases the pleasurable effects of cigarettes and other tobacco products. Nicotine replacement therapy (NRT) includes both nicotine patches and lozenges. Nicotine patches and lozenges can be used together or individually. They also reduce cravings for cigarettes. The Centers for Disease Control states that switching completely to electronic (e)-cigarettes may benefit adult smokers who have exhausted all other treatment options. This clinical trial may help researchers determine if switching to a different treatment is better than continuation of the same treatment for those who struggle to quit smoking.
Inclusion Criteria
Age 21+
Daily smoker (25+ days per previous month)
Smoking 5+ cigarettes/day
Smoking ≥ 1 year (yr)
Willing to set a quit date within 30 days
Provides a valid mailing address
Medical provider approval
Exclusion Criteria
Currently pregnant, breastfeeding, or planning to become pregnant (remote pregnancy testing was included within our two prior randomized controlled trials [RCTs] and worked well)
Have medical contraindications for varenicline or NRT
Currently using smoking cessation medications or e-cigarettes
Household member in study
Additional locations may be listed on ClinicalTrials.gov for NCT06118502.
I. To determine if, among non-responders to an initial course of Food and Drug Administration (FDA)-approved smoking cessation medication (either varenicline or combination NRT), it is better to continue use of the same medication or to switch to another. (Aim 1)
II. To determine if, among non-responders to two courses of FDA-approved medications, it is better to continue use of these same medications or switch to a harm reduction alternative (electronic [e]-cigarette). (Aim 2)
III. To assess 6-month cessation outcomes among smokers who received only FDA-approved cessation medications (varenicline or combination NRT) vs. a harm reduction alternative (e-cigarette). (Aim 3)
OUTLINE:
AIM 1: Participants are randomized to 1 of 2 groups.
* GROUP I: Participants continue receiving their existing smoking cessation treatment, either combination NRT (nicotine patches and lozenges) or varenicline orally (PO) twice daily (BID) for 4 weeks. After 4 weeks, participants who are responders (3 days self-reported non-smoking) continue their existing smoking cessation treatment for an additional 4 weeks. Participants who are non-responders after 4 weeks continue to Aim 2.
* GROUP II: Participants switch to a different smoking cessation treatment, either combination NRT (nicotine patches and lozenges) or varenicline PO for 4 weeks. After 4 weeks, participants who are responders (3 days self-reported non-smoking) continue the different smoking cessation treatment for an additional 4 weeks. Participants who are non-responders after 4 weeks continue to Aim 2.
AIM 2: Participants are randomized to 1 of 2 groups.
* GROUP I: Participants continue receiving their same smoking cessation treatment from Aim 1 for 4 weeks. Participants who respond (3 days self-reported non-smoking) continue their same smoking cessation treatment from Aim 1 for an additional 4 weeks. Participants who are non-responders continue to Aim 3.
* GROUP II: Participants switch to a different smoking cessation treatment than the one received in Aim 1 for 4 weeks. Participants who respond (3 days self-reported non-smoking) continue the different smoking cessation treatment for an additional 4 weeks. Participants who are non-responders continue to Aim 3.
AIM 3: Participants are randomized to 1 of 2 groups.
* GROUP I: Participants continue their same smoking cessation treatment from Aim 2 for 4 weeks.
* GROUP II: Participants receive a four-week supply of e-cigarettes with instructions to try to switch completely from smoking to using an e-cigarette.
After completion of study interventions, patients are followed up at 26 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
