Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07145866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
V-TMS
Brief Summary:
The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (TMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active TMS to varenicline + sham (inactive) TMS to see the effect of TMS on reaching abstinence. The main question it aims to answer is: Does receiving active TMS + varenicline lead to higher abstinence rates and lower nicotine craving?
Participants will be asked to:
* Complete 2 brain MRI scans
* Take varenicline every day for 12 weeks
* Quit using nicotine products at the end of the second week of varenicline
* Complete 5 consecutive days (Monday-Friday, uninterrupted) of TMS treatments
* Complete 12 brief, weekly follow-up visits
* Complete a brief daily survey each day that they take the study drug
Participants will be asked to:
* Complete 2 brain MRI scans
* Take varenicline every day for 12 weeks
* Quit using nicotine products at the end of the second week of varenicline
* Complete 5 consecutive days (Monday-Friday, uninterrupted) of TMS treatments
* Complete 12 brief, weekly follow-up visits
* Complete a brief daily survey each day that they take the study drug
Detailed Description:
This is a 12-week randomized parallel design, double-blind, 2-arm clinical trial consisting of a combination of circuit-targeted TMS and varenicline in 30 adults aged 18-65 with nicotine use disorder who would like to reduce or stop nicotine use.
Eligible participants will complete a baseline assessment of questionnaires and laboratory assessments. They will be randomized to receive varenicline and either active or sham TMS. Participants will be randomized at their baseline scan visit, during which they will undergo urinalysis, an fMRI scan, and a task and questionnaire battery. At this visit, participants will receive the study medication and will be instructed to take it for 12 weeks titrated to 1mg twice daily over seven days.
Shortly after, participants will complete a TMS treatment preparation visit during which the treatment target is located and stimulation intensity of the TMS is determined. This target is used in the subsequent TMS Treatment Week consisting of 5 consecutive days of 5 TMS treatments per day. Participants' quit date will be set for the Saturday following their TMS treatments.
The week after completing their TMS treatments, they will return for a second imaging visit identical to the baseline scan.
Each week of the varenicline treatment period, participants will complete weekly follow-ups with study staff, either virtually or in-person, to determine nicotine use and complete questionnaires regarding their substance use in the past week, depression, and anxiety. Six of these visits will include brief sessions of nicotine use cessation counseling with a trained study staff member.
Eligible participants will complete a baseline assessment of questionnaires and laboratory assessments. They will be randomized to receive varenicline and either active or sham TMS. Participants will be randomized at their baseline scan visit, during which they will undergo urinalysis, an fMRI scan, and a task and questionnaire battery. At this visit, participants will receive the study medication and will be instructed to take it for 12 weeks titrated to 1mg twice daily over seven days.
Shortly after, participants will complete a TMS treatment preparation visit during which the treatment target is located and stimulation intensity of the TMS is determined. This target is used in the subsequent TMS Treatment Week consisting of 5 consecutive days of 5 TMS treatments per day. Participants' quit date will be set for the Saturday following their TMS treatments.
The week after completing their TMS treatments, they will return for a second imaging visit identical to the baseline scan.
Each week of the varenicline treatment period, participants will complete weekly follow-ups with study staff, either virtually or in-person, to determine nicotine use and complete questionnaires regarding their substance use in the past week, depression, and anxiety. Six of these visits will include brief sessions of nicotine use cessation counseling with a trained study staff member.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: