Smoking CessationNCT05276050
Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)
A study testing active F8-coil delivered rTMS and active H-coil delivered rTMS in people with Smoking Cessation and Nicotine Addiction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Smoking Cessation, Nicotine Addiction, Schizophrenia
- What is being tested?
- active F8-coil delivered rTMS and active H-coil delivered rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 14 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female between ages 22-65 years
- 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.
- Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).
- Agrees to: (a) provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and/or has provided service to the subject within two years of study enrollment; and (b) provide the names and verifiable contact information (name, email and mailing address, mobile and land-line phone number, as applicable) of at least two reliable persons ≥ age 22, who reside within a 30-minute drive of the subject's residence, and whom the research staff is at liberty to contact, as deemed necessary, for the duration of study participation.
Who cannot join
- Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.
- 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.
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- History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- Cannot 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.
- Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C- SSRS) Screen Version - Recent (i.e. answers YES to Question 3 and NO to Question 6 (Moderate risk); or answers YES to Questions 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.
- In the medical opinion of the investigator, subjects with the following circumstances or conditions which can increase the risk of seizures may be excluded: sleep deprivation; major depressive disorder comorbid with dementia, underweight status; concurrent use of cephalosporins and antiarrhythmics (particularly propranolol); metabolic abnormalities (hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure); raised blood concentrations of proconvulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections); alcohol withdrawal; use of stimulants, such as cocaine or MDMA; use of immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome; dialysis; systemic infection, and fever itself.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center, Houston
Houston, Texas, 77054
Xiaoming Du, PhD, 410-402-6036, Xiaoming.Du@uth.tmc.edu
Victoria Acosta, 713-486-2740, Victoria.Acosta@uth.tmc.edu
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation, Nicotine Addiction, Schizophrenia
- Being tested
- active F8-coil delivered rTMS, active H-coil delivered rTMS
- Keywords
- Transcranial magnetic stimulation, schizophrenia, smoking, nicotine, tobacco
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Schizophrenia, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active F8-coil delivered rTMSDevice
Multiple trains of rTMS in a day, for multiple days.
active H-coil delivered rTMSDevice
Multiple trains of rTMS in a day, for multiple days.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Participants in this group will receive active F8-coil delivered rTMS. Receives: Device: active F8-coil delivered rTMS |
| Active control group | Active comparator | Participants in this group will receive active H-coil delivered rTMS. Receives: Device: active H-coil delivered rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Cigarette per day
Cigarette per day (CPD) is measured to index smoking reduction and cessation.
Measured: 1 month
Secondary outcomes (3)
Fagerstrom Test for Nicotine Dependence (FTND)
Fagerstrom Test for Nicotine Dependence (FTND) represents the severity of nicotine severity.
Measured: 1 month
nicotine/creatinine
nicotine/creatinine is a index of smoking status.
Measured: 1 month
End-expired carbon monoxide (CO)
End-expired CO measure is an instant measure of smoking status.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Jun 2022
- Primary completion15 Feb 2027 (estimated)
- Study completion14 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Xiaoming Du, The University of Texas Health Science Center, Houston
- Investigators
- Xiaoming Du, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276050
- Sponsor's protocol ID
- HSC-MS-23-0632
- Other IDs
- UH3DA047685
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)
- ClinicalTrials.gov ID
- NCT05276050
- Acronym / sponsor ID
- HSC-MS-23-0632
- Conditions
- Smoking Cessation, Nicotine Addiction, Schizophrenia
- Keywords
- Transcranial magnetic stimulation, schizophrenia, smoking, nicotine, tobacco
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 14 Feb 2028 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: active F8-coil delivered rTMSParticipants in this group will receive active F8-coil delivered rTMS. |
| Active control group | Active comparator | Device: active H-coil delivered rTMSParticipants in this group will receive active H-coil delivered rTMS. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female between ages 22-65 years
- 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.
- Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).
Key exclusion criteria (11 listed)
- Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active F8-coil delivered rTMSMultiple trains of rTMS in a day, for multiple days. | Device | Study group |
| active H-coil delivered rTMSMultiple trains of rTMS in a day, for multiple days. | Device | Active control group |
Primary outcome
Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)
Time frame: 1 month
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
Time frame: 1 month
Cigarette per day (CPD) is measured to index smoking reduction and cessation.
3 secondary outcomes
Fagerstrom Test for Nicotine Dependence (FTND)
Time frame: 1 month
nicotine/creatinine
Time frame: 1 month
End-expired carbon monoxide (CO)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoming Du, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active F8-coil delivered rTMS and active H-coil delivered rTMS in people with Smoking Cessation and Nicotine Addiction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Du, PhD (443-882-9717, Xiaoming.Du@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.