N/A
Completed N=30
Circuitry-Guided Smoking Cessation in Schizophrenia
Source: ClinicalTrials.gov NCT03281629 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Cigarette Per Day — -3.2; -3.0; -2.71; -2.50 cigarettes per day
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarette Per Day |
-3.2; -3.0; -2.71; -2.50; -2.50; -3.50 | — |
| SECONDARY Functional Magnetic Resonance Imaging (fMRI) |
0.025; -0.014; 0.044; -0.034 | — |
| SECONDARY Cotinine |
-112; 31 | — |
| SECONDARY End-expired Carbon Monoxide (CO) |
-0.67; -2.40 | — |
| SECONDARY Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG) |
24.0; -38.0; -5.5; 35.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female between ages 18-60
- Ability to give written informed consent (age 18 or above)
- Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks.
- For patient participants, Evaluation to Sign Consent (ESC) above10.
Exclusion Criteria
- Any history of seizures
- Had smoking cessation treatment, clinical trial, or nicotine replacements within the past four weeks.
- Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
- Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
- Taking > 400 mg clozapine/day
- Failed TMS screening questionnaire
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- Can not refrain from using alcohol and/or marijuana 24 hours or more & cigarette smoking one hour or more prior to experiments.
- Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test).
Data sourced from ClinicalTrials.gov (NCT03281629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.