Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474299
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
The Avenues Study Dual Use Cessation
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Dual Use Cessation A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
To be efficient and maximize translation potential the investigators will use the efficient Multiphase Optimization Strategy MOST to identify an optimal intervention to help people who use both cigarettes and ENDS quit smoking cigarettes As such in this randomized 2x2x2 factorial screening trial the investigators will examine three intervention factors
1 Pharmacotherapy varenicline vs nicotine patch
2 Counseling Intensity 4 vs 1 session
3 Counseling Approach Dual Focused vs Smoking Focused
The Dual Focused counseling approach will encourage participants to quit their ENDS use as part of their smoking cessation attempt The Smoking Focused counseling approach will encourage participants to quit smoking but not vaping and to use their ENDS strategically to deal with urges in service of harm reduction There is theoretical and empirical support for these pharmacologic and counseling approaches and intensities
Participants N500 will be dual users of cigarettes 4 cigsday for the last 6 months and ENDS vape weekly for at least 6 months who are motivated to quit smoking and willing try to quit vaping if asked to do so Participants will be randomized to receive either varenicline or nicotine patches for 12 weeks to receive either one or four 15-20-minute counseling sessions and to receive counseling that is either dual focused or smoking focused Dual Focused Cessation will focus on quitting both smoking and vaping on the target quit date TQD Pre-TQD participants will be instructed to change smoking and vaping patterns eg not smoking or vaping in specific places or at specific times of day Post-TQD participants will focus on building smoking and vaping cessation skills eg coping with cravings to smoke or vape avoiding smoking and vaping cues Smoking Focused Cessation will focus on quitting smoking on the TQD and using ENDS as a behavioral substitute ie using ENDS as a cigarette substitute Pre-TQD participants will be instructed to change smoking patterns eg vaping rather than smoking in specific places or at specific times of day vaping first in the morning rather than smoking and practice smoking cessation coping strategies eg substituting ENDS for cigarettes avoiding smoking cues Participants will be advised to quit smoking on the TQD and not worry about quitting vaping at this point Participants will complete daily measures of smoking vaping and potential change mechanisms eg craving smoking reward self-efficacy via ecological momentary assessment EMA for 2 weeks pre-TQD and 2 weeks post-TQD Follow-up will occur for 12 months post-TQD
Primary Objective Determine which pharmacologic and counseling approaches are especially effective alone or in combination in helping dual users quit smoking
Secondary Objectives
Examine the effects of the treatments on variables that may mediate treatment effects on smoking cessation
Examine
1 changes in vaping intensity and vaping cessation
2 moderators of treatment effects eg cigarette dependence race menthol use ENDS characteristics and
3 whether continued vaping is related to cigarette lapse and relapse amongst those who have quit smoking
1 Pharmacotherapy varenicline vs nicotine patch
2 Counseling Intensity 4 vs 1 session
3 Counseling Approach Dual Focused vs Smoking Focused
The Dual Focused counseling approach will encourage participants to quit their ENDS use as part of their smoking cessation attempt The Smoking Focused counseling approach will encourage participants to quit smoking but not vaping and to use their ENDS strategically to deal with urges in service of harm reduction There is theoretical and empirical support for these pharmacologic and counseling approaches and intensities
Participants N500 will be dual users of cigarettes 4 cigsday for the last 6 months and ENDS vape weekly for at least 6 months who are motivated to quit smoking and willing try to quit vaping if asked to do so Participants will be randomized to receive either varenicline or nicotine patches for 12 weeks to receive either one or four 15-20-minute counseling sessions and to receive counseling that is either dual focused or smoking focused Dual Focused Cessation will focus on quitting both smoking and vaping on the target quit date TQD Pre-TQD participants will be instructed to change smoking and vaping patterns eg not smoking or vaping in specific places or at specific times of day Post-TQD participants will focus on building smoking and vaping cessation skills eg coping with cravings to smoke or vape avoiding smoking and vaping cues Smoking Focused Cessation will focus on quitting smoking on the TQD and using ENDS as a behavioral substitute ie using ENDS as a cigarette substitute Pre-TQD participants will be instructed to change smoking patterns eg vaping rather than smoking in specific places or at specific times of day vaping first in the morning rather than smoking and practice smoking cessation coping strategies eg substituting ENDS for cigarettes avoiding smoking cues Participants will be advised to quit smoking on the TQD and not worry about quitting vaping at this point Participants will complete daily measures of smoking vaping and potential change mechanisms eg craving smoking reward self-efficacy via ecological momentary assessment EMA for 2 weeks pre-TQD and 2 weeks post-TQD Follow-up will occur for 12 months post-TQD
Primary Objective Determine which pharmacologic and counseling approaches are especially effective alone or in combination in helping dual users quit smoking
Secondary Objectives
Examine the effects of the treatments on variables that may mediate treatment effects on smoking cessation
Examine
1 changes in vaping intensity and vaping cessation
2 moderators of treatment effects eg cigarette dependence race menthol use ENDS characteristics and
3 whether continued vaping is related to cigarette lapse and relapse amongst those who have quit smoking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA290895 | NIH | None | None |
| A534253 | OTHER | None | None |
| SMPHMEDICINEGEN INT MD | OTHER | None | None |
| Protocol Version 2222024 | OTHER | None | None |