Circuitry-Guided Smoking Cessation in Schizophrenia



Status:Recruiting
Conditions:Schizophrenia, Smoking Cessation, Smoking Cessation
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:6/27/2018
Start Date:May 18, 2018
End Date:December 30, 2022
Contact:Xiaoming Du, PhD
Email:xdu@mprc.umaryland.edu
Phone:410-402-6036

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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.

Neuroimaging studies suggest that high rate of smoking in patients with schizophrenia may be
due to an overlap of nicotine addiction related circuitries and schizophrenia related
circuitries, such that schizophrenia impact some of the same circuitries that increase risks
for severe nicotine addiction in general. Those identified overlapping circuitries have been
linked to several key features of nicotine addiction and can be represented by resting state
functional connectivities. Transcranial magnetic stimulation (TMS) provides a non-invasive
means for altering brain electrical neural activity. TMS has been approved by FDA for
treatment of depression. Other applications have not been approved but it has been used in a
wide range of clinical research especially in neurology and psychiatry. There are
preliminarily significant improvements in treatments of smoking cessation in schizophrenia
using TMS with small samples, but those treatments are not robust in larger samples. The high
inter-subject variability limits the efficacy of TMS treatment in schizophrenia patients. We
aim to develop a TMS method targeting special brain circuits that are both smoking cessation
and schizophrenia related. If the corresponding brain circuits were successfully modulated,
the treatment efficacy will be significantly improved and schizophrenia patients will benefit
from the TMS treatment of smoking cessation.

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).
We found this trial at
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
Phone: 410-402-6036
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