Trial Outcomes & Findings for QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt (NCT NCT04159571)

Last Updated: 2024-05-21

Results Overview

Questionnaire on Smoking Urges (QSU). This 10-item questionnaire assesses cigarette craving. Participants will be asked to rate from 1 (strongly disagree) to 7 (strongly agree) their agreement with several statements (e.g., "I have a desire for a cigarette right now," and "Nothing would be better than smoking a cigarette right now."). Individual scores can range from 7 to 49. Higher scores represent more craving. QSU scores are averaged per individual per time point. Scores for all time points and all participants were averaged for each arm (real vs sham TMS).

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Through study completion, an average of 8 weeks

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Real TBS to the vmPFC Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded)	Sham TBS to the vmPFC Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
Overall Study STARTED	26	14
Overall Study COMPLETED	15	8
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real TBS to the vmPFC n=25 Participants Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded)	Sham TBS to the vmPFC n=13 Participants Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.	Total n=38 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 12 • n=5 Participants	54 years STANDARD_DEVIATION 15 • n=7 Participants	55 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	13 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 8 weeks

Outcome measures

Outcome measures
Measure	Real TBS to the vmPFC n=26 Participants Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded)	Sham TBS to the vmPFC n=14 Participants Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving	16 units on a scale Standard Deviation 8	12 units on a scale Standard Deviation 3

PRIMARY outcome

Timeframe: Through study completion, an average of 8 weeks

This self-reported tobacco product use interview asks participants to retrospectively estimate the number of cigarettes they've used each day for the past 30 days or since the previous assessment, whichever is fewer.

Outcome measures

Outcome measures
Measure	Real TBS to the vmPFC n=25 Participants Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded)	Sham TBS to the vmPFC n=13 Participants Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
Self- Report Assessment of Cigarette Use Through Timeline Follow-Back (TLFB) Interview	10 number of cigarettes per day Standard Deviation 9	12 number of cigarettes per day Standard Deviation 8

SECONDARY outcome

Timeframe: Through study completion, an average of 8 weeks

Changes in cigarette use as detected by quantitative cotinine urine screens collected at visits 1, 6, 10, and all follow-ups. Values are averaged across all time points.

Outcome measures

Outcome measures
Measure	Real TBS to the vmPFC n=25 Participants Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded)	Sham TBS to the vmPFC n=13 Participants Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level	1872 ng/ml Standard Deviation 1705	1374 ng/ml Standard Deviation 1079

Adverse Events

Real TBS to the vmPFC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham TBS to the vmPFC

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Real TBS to the vmPFC n=25 participants at risk Ten sessions of real Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Real TBS to the vmPFC: This will be delivered with the Magventure Magpro system; active sham coil (double blinded)	Sham TBS to the vmPFC n=13 participants at risk Ten sessions of sham Theta Burst Stimulation (TBS) will be delivered to the left medial prefrontal cortex (mPFC) Sham cTBS to the vmPFC: The MagVenture MagPro system has an integrated active sham that uses two surface electrodes placed on the skin beneath the coil.
General disorders headache	4.0% 1/25 • Number of events 1 • 2 months	0.00% 0/13 • 2 months
General disorders drooping eyelid	0.00% 0/25 • 2 months	7.7% 1/13 • Number of events 1 • 2 months
General disorders memory problem	0.00% 0/25 • 2 months	7.7% 1/13 • Number of events 1 • 2 months

Additional Information

Merideth Addicott, PhD

Wake Forest University School of Medicine

Phone: 336-716-7792

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place