- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03281629
Circuitry-Guided Smoking Cessation in Schizophrenia
December 21, 2022 updated by: Xiaoming Du, University of Maryland, Baltimore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21228
- University of Maryland, Baltimore
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active TMS stimulation
Real active rTMS stimulation.
|
Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
|
Sham Comparator: Sham TMS stimulation
Sham repetitive TMS stimulation.
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Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cigarette Per Day
Time Frame: 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.
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7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Magnetic Resonance Imaging (fMRI)
Time Frame: 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, 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).
|
4 months
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Cotinine
Time Frame: 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).
|
1 month
|
End-expired Carbon Monoxide (CO)
Time Frame: 1 month
|
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).
|
1 month
|
Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG)
Time Frame: 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 collected at 6-month follow up (7-month time point).
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4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xiaoming Du, MD, University of Maryland, Baltimore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2018
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
February 15, 2022
Study Registration Dates
First Submitted
September 1, 2017
First Submitted That Met QC Criteria
September 11, 2017
First Posted (Actual)
September 13, 2017
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00077085
- UG3DA047685 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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