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Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

Primary Purpose

Smoking Cessation, Nicotine Addiction, Schizophrenia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

active F8-coil delivered rTMS

active H-coil delivered rTMS

About this trial

This is an interventional other trial for Smoking Cessation focused on measuring Transcranial magnetic stimulation, schizophrenia, smoking, nicotine, tobacco

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female between ages 18-60
Ability to give written informed consent
Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks.
Diagnosed with schizophrenia-spectrum disorder and 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 or 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) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
Have active suicidal ideation and behavior.

Sites / Locations

University of Maryland, BaltimoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Active control group

Arm Description

Participants in this group will receive active F8-coil delivered rTMS.

Participants in this group will receive active H-coil delivered rTMS.

Outcomes

Primary Outcome Measures

Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)

The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the TMS effect on smoking reduction/cessation.

Cigarette per day

Cigarette per day (CPD) is measured to index smoking reduction and cessation.

Secondary Outcome Measures

Fagerstrom Test for Nicotine Dependence (FTND)

Fagerstrom Test for Nicotine Dependence (FTND) represents the severity of nicotine severity.

nicotine/creatinine

nicotine/creatinine is a index of smoking status.

End-expired carbon monoxide (CO)

End-expired CO measure is an instant measure of smoking status.

Full Information

NCT ID

NCT05276050

First Posted

March 2, 2022

Last Updated

November 15, 2022

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT05276050

Brief Title

Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

Official Title

Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

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 impacts 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. The investigators 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. The F8 coil based rTMS is not FDA approved for smoking cessation at this point, the rTMS with H4 coil is FDA-cleared for short-term smoking cessation in the general population, its efficacy in SSD has not been evaluated. In this protocol, the investigators will compare them in patients with schizophrenia spectrum disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Nicotine Addiction, Schizophrenia

Keywords

Transcranial magnetic stimulation, schizophrenia, smoking, nicotine, tobacco

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Participants in this group will receive active F8-coil delivered rTMS.

Arm Title

Active control group

Arm Type

Active Comparator

Arm Description

Participants in this group will receive active H-coil delivered rTMS.

Intervention Type

Device

Intervention Name(s)

active F8-coil delivered rTMS

Intervention Description

Multiple trains of rTMS in a day, for multiple days.

Intervention Type

Device

Intervention Name(s)

active H-coil delivered rTMS

Intervention Description

Multiple trains of rTMS in a day, for multiple days.

Primary Outcome Measure Information:

Title

Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)

Description

The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the TMS effect on smoking reduction/cessation.

Time Frame

1 month

Title

Cigarette per day

Description

Cigarette per day (CPD) is measured to index smoking reduction and cessation.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Fagerstrom Test for Nicotine Dependence (FTND)

Description

Fagerstrom Test for Nicotine Dependence (FTND) represents the severity of nicotine severity.

Time Frame

1 month

Title

nicotine/creatinine

Description

nicotine/creatinine is a index of smoking status.

Time Frame

1 month

Title

End-expired carbon monoxide (CO)

Description

End-expired CO measure is an instant measure of smoking status.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female between ages 18-60 Ability to give written informed consent Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks. Diagnosed with schizophrenia-spectrum disorder and 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 or 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) or has had unprotected sexual intercourse without birth control in the last 4 weeks. Have active suicidal ideation and behavior.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoming Du, PhD

Phone

410-402-6036

xdu@som.umaryland.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kimberly Tate

Phone

410-402-6008

KTate@som.umaryland.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoming Du, PhD

Organizational Affiliation

University of Maryland, Baltimore

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland, Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoming Du, PhD

Phone

410-402-6036

xdu@som.umaryland.edu

First Name & Middle Initial & Last Name & Degree

Kimberly Tate

Phone

410-402-6008

KTate@som.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD

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Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

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