Adults 18 to 60, any sex, with Smoking Cessation or Nicotine Addiction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cigarette Per DayPrimary· 7 months
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.
Baseline versus End-of-Treatment (1 month)
Group
Value
95% CI
Active TMS Stimulation
-3.2
± 4.9
Sham TMS Stimulation
-3.0
± 5.1
Baseline versus 3-month follow up (4 months time point)
Group
Value
95% CI
Active TMS Stimulation
-2.71
± 3.10
Sham TMS Stimulation
-2.50
± 3.32
Baseline versus 6-month follow up (7 months time point)
Group
Value
95% CI
Active TMS Stimulation
-2.50
± 2.04
Sham TMS Stimulation
-3.50
± 4.95
Functional Magnetic Resonance Imaging (fMRI)Secondary· 4 months
Resting-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, strong
Baseline versus End-of-Treatment (1 month time point)
Group
Value
95% CI
Active TMS Stimulation
0.025
± 0.047
Sham TMS Stimulation
-0.014
± 0.047
Baseline versus 3-month follow up (4 months time point)
Group
Value
95% CI
Active TMS Stimulation
0.044
± 0.045
Sham TMS Stimulation
-0.034
± 0.011
CotinineSecondary· 1 month
Cotinine 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).
End-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).
Group
Value
95% CI
Active TMS Stimulation
-0.67
± 9.04
Sham TMS Stimulation
-2.40
± 4.50
Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG)Secondary· 4 months
EEG 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 co
Baseline versus End-pf-Treatment (1 month time point)
Group
Value
95% CI
Active TMS Stimulation
24.0
± 37.0
Sham TMS Stimulation
-38.0
± 64.0
Baseline versus 3-month follow up (4 months time point)
Group
Value
95% CI
Active TMS Stimulation
-5.5
± 15.5
Sham TMS Stimulation
35.1
± 32.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline to the time when the participant completes or quits the study (up to 7 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
In a double-blinded, randomized, parallel controlled design, patients with schizophrenia spectrum disorder will be exposed to active or sham repetitive transcranial magentic stimulation (TMS) which was guided by functional magnetic resonance image (MRI). Smoking reduction/cessation and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
Last refreshed: 18 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03281629.