The Avenues Study: Dual Use Cessation

Summary

The overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.

Conditions

• Smoking Cessation
• Electronic Cigarette Use

Interventions

DRUG

Varenicline

0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily

DRUG

Nicotine patch

Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.

BEHAVIORAL

Dual Focused Cessation Counseling

Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).

BEHAVIORAL

Smoking Focused Cessation Counseling

Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).

OTHER

Counseling Intensity: 1 Session

Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).

OTHER

Counseling Intensity: 4 Sessions

Participants assigned to intensive counseling will have four, 15-20-minute sessions.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Megan E Piper, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-24

Primary Completion

2028-07-31

Completion

2028-07-31

FDA Drug

Yes

Countries

• United States

Study Locations