Circuitry-Guided Smoking Cessation in Schizophrenia
2 other identifiers
interventional
44
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedStudy Start
First participant enrolled
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedResults Posted
Study results publicly available
January 18, 2023
CompletedJanuary 18, 2023
December 1, 2022
2.4 years
September 1, 2017
September 23, 2022
December 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cigarette Per Day
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.
7 months
Secondary Outcomes (4)
Functional Magnetic Resonance Imaging (fMRI)
4 months
Cotinine
1 month
End-expired Carbon Monoxide (CO)
1 month
Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG)
4 months
Study Arms (2)
Active TMS stimulation
ACTIVE COMPARATORReal active rTMS stimulation.
Sham TMS stimulation
SHAM COMPARATORSham repetitive TMS stimulation.
Interventions
Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland, Baltimore
Baltimore, Maryland, 21228, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Xiaoming Du
- Organization
- Maryland Psychiatric Research Center, University of Maryland School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoming Du, MD
University of Maryland, Baltimore
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professsor
Study Record Dates
First Submitted
September 1, 2017
First Posted
September 13, 2017
Study Start
October 19, 2018
Primary Completion
February 28, 2021
Study Completion
February 15, 2022
Last Updated
January 18, 2023
Results First Posted
January 18, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share