Clinical trial NCT06087328: CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes
Official title: Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Electronic Cigarette Use
Cigarette Smoking
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2023-10-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.

Detailed description: Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.

Eligibility criteria: Inclusion Criteria:

* Age 18yrs +
* Daily nicotine-containing e-cigarette user (25+ days per previous month)
* E-cigarette use 5+ times/day
* E-cigarette use \> 1year
* Smoking \>1 cigarette on 5-7 days per week
* Interest in quitting smoking and e-cigarette within the next month (\>7 on 10-point scale)
* Willingness to use NRT
* Able to receive text messages/email
* Mailing address in South Carolina.

Exclusion Criteria:

* Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated)
* Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications
* Those who vape non-nicotine substances
* Individuals unable to consent (e.g. significant cognitive deficit, non-English speaking).

Primary outcomes:
measure: Days of dual use abstinence
timeFrame: Day 28, Day 56
Secondary outcomes:
measure: Reduction
timeFrame: Day 28, Day 56
measure: Safety
timeFrame: Day 28
measure: Feasibility/Acceptability
timeFrame: Day 28
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina - Charleston
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Amanda Palmer
role: PRINCIPAL_INVESTIGATOR
References: