Trial Outcomes & Findings for QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt (NCT NCT03576768)

Last Updated: 2021-03-24

Results Overview

The Fagerstrom Test for Nicotine Dependence will be measured at Visit 1 and after 10 days of treatment (Visit 10). In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerstrom score, the more intense is the patient's physical dependence on nicotine. .For this outcome we will measure the difference in the score for those that completed the study. This difference will be compared between the study arms.

Recruitment status

TERMINATED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Baseline and 10 days

Results posted on

2021-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Real cTBS to the vmPFC Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Overall Study STARTED	13	12
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Real cTBS to the vmPFC Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Real iTBS to the dlPFC Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).	Sham iTBS to the dlPFC Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Overall Study Lost to Follow-up	3	3	0	0

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 cTBS to the vmPFC n=13 Participants Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC n=12 Participants Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Real iTBS to the dlPFC Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).	Sham iTBS to the dlPFC Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	—	—	25 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	—	—	12 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	—	—	13 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	—	—	6 Participants n=21 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	11 Participants n=7 Participants	—	—	19 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	—	—	25 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 10 days

Population: Data was analyzed for all participants that completed the experiment per protocol

Outcome measures

Outcome measures
Measure	Real cTBS to the vmPFC n=10 Participants Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC n=10 Participants Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Real iTBS to the dlPFC Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).	Sham iTBS to the dlPFC Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Change in Cigarette Dependence After 10 Days of Treatment	-2.70 units on a scale Standard Error 0.99	-1.44 units on a scale Standard Error 0.96	—	—

SECONDARY outcome

Timeframe: Baseline and 10 days

Population: The study was ended before individuals were randomized into the Real iTBS and Sham iTBS arms

The urge for a cigarette will be measured at Visit 1 and after 10 days of treatment (Visit 10) using the Questionnaire of Smoking Urges 10 question assessment with a scoring range of 0-100. The lower the score, the lower the urge to smoke a cigarette. The higher the score, the higher the urge to smoke a cigarette. For this outcome we will measure the difference at Visit 10 versus Visit 1 for those that completed the study. This difference will be compared between the study arms.

Outcome measures

Outcome measures
Measure	Real cTBS to the vmPFC n=10 Participants Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC n=10 Participants Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Real iTBS to the dlPFC Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).	Sham iTBS to the dlPFC Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Change in Urge for a Cigarette	-29.2 score on a scale Standard Error 11.04	-28.8 score on a scale Standard Error 14.9	—	—

SECONDARY outcome

Timeframe: Baseline and 10 days

Population: The study ended before participants were randomized to the Real and Sham iTBS arms.

The number of cigarettes smoked in the previous week will be measured at Visit 1 and after 10 days of treatment (Visit 10) via an environmental momentary assessment which is passed on self-report. The dependent measure will be a 'count' of cigarettes. The difference will be compared between the study arms.

Outcome measures

Outcome measures
Measure	Real cTBS to the vmPFC n=10 Participants Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC n=10 Participants Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Real iTBS to the dlPFC Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).	Sham iTBS to the dlPFC Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Changes in Cigarette Use	7.55 cigarettes Standard Error 1.01	8.89 cigarettes Standard Error 1.58	—	—

Adverse Events

Real cTBS to the vmPFC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham cTBS to the vmPFC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Real iTBS to the dlPFC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham iTBS to the dlPFC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Real cTBS to the vmPFC n=13 participants at risk Ten sessions of real continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Real cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)	Sham cTBS to the vmPFC n=12 participants at risk Ten sessions of sham continuous Theta Burst Stimulation (cTBS) will be delivered to the left medial prefrontal cortex (mPFC) (1 train of stimulation over the left frontal pole (FP1); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 40 sec, 600 pulses/train, 110% RMT, MagPro; 600 pulses total) Sham cTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.	Real iTBS to the dlPFC Ten sessions of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Real iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).	Sham iTBS to the dlPFC Ten sessions of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) (20 trains of stimulation over dlPFC (middle frontal gyrus) (F3); each train: 3 pulse bursts presented at 5Hz, 15 pulses/sec for 2 sec, 8 sec rest, 200 pulses/train; 110% RMT, MagPro; 600 pulses total) Sham iTBS: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
Nervous system disorders Migraine	0.00% 0/13 • Adverse Events were collected over the course of the study until study termination which was 2 months. The study was ended before any participants were randomized to the real or Sham iTBS arms.	8.3% 1/12 • Number of events 1 • Adverse Events were collected over the course of the study until study termination which was 2 months. The study was ended before any participants were randomized to the real or Sham iTBS arms.	— 0/0 • Adverse Events were collected over the course of the study until study termination which was 2 months. The study was ended before any participants were randomized to the real or Sham iTBS arms.	— 0/0 • Adverse Events were collected over the course of the study until study termination which was 2 months. The study was ended before any participants were randomized to the real or Sham iTBS arms.

Additional Information

Colleen Hanlon, PhD

Medical University of South Carolina

Phone: 843-792-9888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place