The Avenues Study: Dual Use Cessation

Conditions

• Electronic Cigarette Use
• Smoking Cessation

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Varenicline — DRUG
  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
• Nicotine patch — DRUG
  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.
• Dual Focused Cessation Counseling — BEHAVIORAL
  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).
• Smoking Focused Cessation Counseling — BEHAVIORAL
  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).
• Counseling Intensity: 1 Session — OTHER
  Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).
• Counseling Intensity: 4 Sessions — OTHER
  Participants assigned to intensive counseling will have four, 15-20-minute sessions.

Study Details

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.

Key Dates

Start date

Sep 24, 2024

Status verified

Apr 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Varenicline, Dual Focused, 1 session
• Active Comparator: Varenicline, Dual Focused, 4 sessions
• Active Comparator: Varenicline, Smoking Focused, 1 session
• Active Comparator: Varenicline, Smoking Focused, 4 sessions
• Active Comparator: Nicotine Patches, Dual Focused, 1 session
• Active Comparator: Nicotine Patches, Dual Focused, 4 sessions
• Active Comparator: Nicotine Patches, Smoking Focused, 1 session
• Active Comparator: Nicotine Patches, Smoking Focused, 4 sessions

Primary Outcome Measure

52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes [ Time Frame: up to 52 weeks ]

Central Contacts

• Mark Zehner
  608-262-7568
  [email protected]

Locations (1)

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