CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes (CAN-DOSE)

Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Electronic Cigarette Use; Cigarette Smoking
• Intervention / Treatment: Drug: Regular Nicotine patch and lozenge dose; Drug: Augmented Nicotine patch and lozenge dose

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rachel Christian; Phone Number: (843) 737-1516; Email: chrisrac@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Recruiting
      • Medical University of South Carolina - Charleston
      • Contact: Marian Chelsea Evangelista; Phone Number: 843-509-7589; Email: evangema@musc.edu
      • Contact: Rachel Christian; Phone Number: (843) 737-1516; Email: chrisrac@musc.edu
      • Principal Investigator: Amanda Palmer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; 21mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day]	Drug: Regular Nicotine patch and lozenge dose; 1mg patch, qd + 4mg lozenge prn [minimum of 5 & up to 20 per day]
Active Comparator: Arm B; 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 & [up to 30 per day]	Drug: Augmented Nicotine patch and lozenge dose; 21mg patch + 14mg patch qd + 4mg lozenge prn [minimum of 5 & up to 30 per day] OR 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day]
Active Comparator: Arm C; 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day]	Drug: Augmented Nicotine patch and lozenge dose; 21mg patch + 14mg patch qd + 4mg lozenge prn [minimum of 5 & up to 30 per day] OR 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 & up to 40 per day]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of dual use abstinence	Number of days participants self-report abstinence from both e-cigarettes and smoking.	Day 28, Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction	Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment.	Day 28, Day 56
Safety	Adverse events between groups will be evaluated. NRT side effects will be captured during daily diary assessments using the Systematic Assessment for Treatment Emergent Events (SAFTEE)	Day 28
Feasibility/Acceptability	Will be determined by the proportion of eligible subjects able to be contacted who subsequently enroll, the proportion of enrolled subjects who complete the Day 28 survey, and the proportion of enrolled subjects who complete ≥80% of their daily surveys during the treatment period. Participants will report satisfaction and helpfulness of the intervention at the end of treatment	Day 28

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Amanda Palmer, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro00130184; IRG-19-137-20 (Other Grant/Funding Number: American Cancer Society Institutional Research Grant)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No