Trial Outcomes & Findings for Circuitry-Guided Smoking Cessation in Schizophrenia (NCT NCT03281629)
NCT ID: NCT03281629
Last Updated: 2023-01-18
Results Overview
Cigarette per day (CPD) is measured to index smoking reduction and cessation. The change of CPD between baseline and end-of-treatment (1-month time point), 3-month follow up (4-month time point) and 6-month follow up (7-month time point) are reported. Negative values of the change of CPD indicate reductions in cigarette consumption.
COMPLETED
NA
44 participants
7 months
2023-01-18
Participant Flow
Fourteen enrolled participants were excluded from the study before assignment to groups. Six of them were excluded because they failed inclusion/exclusion criteria; six of them were excluded due to schedule conflict; one was excluded because the participant cannot fit into MRI scanner; one was excluded because the participant changed mind and decided to quit.
Participant milestones
| Measure |
Active TMS Stimulation
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
12
|
|
Overall Study
COMPLETED
|
16
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Active TMS Stimulation
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Overall Study
The two participants dropped out due to COVID-19 lockdown.
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Participant's schedule change and cannot participate in the study
|
0
|
1
|
Baseline Characteristics
Circuitry-Guided Smoking Cessation in Schizophrenia
Baseline characteristics by cohort
| Measure |
Active TMS Stimulation
n=18 Participants
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 Participants
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 monthsCigarette per day (CPD) is measured to index smoking reduction and cessation. The change of CPD between baseline and end-of-treatment (1-month time point), 3-month follow up (4-month time point) and 6-month follow up (7-month time point) are reported. Negative values of the change of CPD indicate reductions in cigarette consumption.
Outcome measures
| Measure |
Active TMS Stimulation
n=18 Participants
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 Participants
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Cigarette Per Day
Baseline versus End-of-Treatment (1 month)
|
-3.2 cigarettes per day
Standard Deviation 4.9
|
-3.0 cigarettes per day
Standard Deviation 5.1
|
|
Cigarette Per Day
Baseline versus 3-month follow up (4 months time point)
|
-2.71 cigarettes per day
Standard Deviation 3.10
|
-2.50 cigarettes per day
Standard Deviation 3.32
|
|
Cigarette Per Day
Baseline versus 6-month follow up (7 months time point)
|
-2.50 cigarettes per day
Standard Deviation 2.04
|
-3.50 cigarettes per day
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: 4 monthsResting-state functional connectivity (rsFC) obtained from fMRI is used to evaluate the TMS effect on smoking cessation. The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. According to our pilot data determined from a separate study, stronger rsFC (i.e., larger positive z score) was related to less smoking severity. The changes of rsFC between baseline and end-of-treatment (1-month time point) and 3-month follow up (4-month time point) are reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by the intervention. No fMRI data were collected at 6-month follow up (7-month time point).
Outcome measures
| Measure |
Active TMS Stimulation
n=18 Participants
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 Participants
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Functional Magnetic Resonance Imaging (fMRI)
Baseline versus End-of-Treatment (1 month time point)
|
0.025 z score of functional connectivity
Standard Deviation 0.047
|
-0.014 z score of functional connectivity
Standard Deviation 0.047
|
|
Functional Magnetic Resonance Imaging (fMRI)
Baseline versus 3-month follow up (4 months time point)
|
0.044 z score of functional connectivity
Standard Deviation 0.045
|
-0.034 z score of functional connectivity
Standard Deviation 0.011
|
SECONDARY outcome
Timeframe: 1 monthCotinine level is an objective index of smoking status. Higher level of cotinine indicates more nicotine consumption. The change of cotinine level between baseline and end-of-treatment (1-month time point) is reported. Cotinine data were not collected at 3-month follow up (4-month time point) or 6-month follow up (7-month time point).
Outcome measures
| Measure |
Active TMS Stimulation
n=18 Participants
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 Participants
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Cotinine
|
-112 ng/ml
Standard Deviation 1114
|
31 ng/ml
Standard Deviation 561
|
SECONDARY outcome
Timeframe: 1 monthEnd-expired CO measure is an instant measure of smoking status. Higher CO level indicates more nicotine consumption. The change of CO level between baseline and end-of-treatment (1-month time point) is reported. No CO data were collected at 3-month follow up (4-month time point) or 6-month follow up (7-month time point).
Outcome measures
| Measure |
Active TMS Stimulation
n=18 Participants
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 Participants
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
End-expired Carbon Monoxide (CO)
|
-0.67 ppm
Standard Deviation 9.04
|
-2.40 ppm
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: 4 monthsEEG is used to evaluate the brain activities that are corresponding to the TMS. Auditory static state response (ASSR) at gamma frequency (i.e., 40 Hz) is obtained from the EEG recording. The gamma power of ASSR was normalized as the ratio between the power at 40 Hz (i.e., gamma power) and the power of its neighboring frequencies (i.e., 39 and 41 Hz). Increased normalized gamma ASSR is usually related to the improvement of psychosis symptoms. The change of ASSR between baseline and end-of-treatment (1-month time point) and 3-month follow up (4-month time point) are reported. No EEG data were collected at 6-month follow up (7-month time point).
Outcome measures
| Measure |
Active TMS Stimulation
n=18 Participants
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 Participants
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG)
Baseline versus End-pf-Treatment (1 month time point)
|
24.0 ratio
Standard Deviation 37.0
|
-38.0 ratio
Standard Deviation 64.0
|
|
Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG)
Baseline versus 3-month follow up (4 months time point)
|
-5.5 ratio
Standard Deviation 15.5
|
35.1 ratio
Standard Deviation 32.8
|
Adverse Events
Active TMS Stimulation
Sham TMS Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TMS Stimulation
n=18 participants at risk
Real active rTMS stimulation.
Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham TMS Stimulation
n=12 participants at risk
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Facial muscle twitching
|
44.4%
8/18 • Number of events 8 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
0.00%
0/12 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Eye blinks
|
27.8%
5/18 • Number of events 5 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
0.00%
0/12 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
|
Nervous system disorders
headache
|
22.2%
4/18 • Number of events 4 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
33.3%
4/12 • Number of events 4 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
8.3%
1/12 • Number of events 1 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
8.3%
1/12 • Number of events 1 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
|
General disorders
Pain
|
22.2%
4/18 • Number of events 4 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
0.00%
0/12 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
|
Ear and labyrinth disorders
Uncomfortable click sounds
|
22.2%
4/18 • Number of events 4 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
8.3%
1/12 • Number of events 1 • From baseline to the time when the participant completes or quits the study (up to 7 months).
|
Additional Information
Dr. Xiaoming Du
Maryland Psychiatric Research Center, University of Maryland School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place