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Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

StatusRecruiting
PhaseNot applicable
Started2022-06-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jul 28, 2026 → Feb 15, 2027
See other at-risk trials from The University of Texas Health Science Center, Houston

Amendment history

2026-09-17
Primary completion pushed: 2026-07-28 → 2027-02-15
Completion pushed: 2027-01-30 → 2028-02-14
2026-01-08
Study Status v8
Primary completion date2026-02-28→2026-07-28
Completion date2027-06-30→2027-01-30
2025-06-09
Study Status v7
Primary completion date2025-02-28→2026-02-28
Completion date2026-06-30→2027-06-30
2024-07-18
Study Identification, Study Status, Sponsor/Collaborators v6
Collaborators+39 characters
National Institute on Drug Abuse (NIDA)
2024-03-28
Study Status v5
Re-verified, no change to tracked fields
Show 4 earlier versions
2024-02-08
Study Identification, Study Status, Sponsor/Collaborators, Study Design, Eligibility, Contacts/Locations v4
Lead sponsorUniversity of Maryland, Baltimore→The University of Texas Health Science Center, Houston
Eligibility criteria+2,166 characters
Inclusion Criteria: Male and female between ages 1822-6065 years Ability to give written informed consent Smoking in the las [...] r 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 inve [...] Exclusion Criteria: A [...] [...]
Study sites1 entry, revised
The University of MarylandTexas Health Science Center, BaltimoreHouston
2022-11-15
Study Status v3
Primary completion date2025-02→2025-02-28
Completion date2025-02→2026-06-30
2022-08-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-06→confirmed 2022-06-01
Study sitesdetails revised at 1 of 1 site
2022-03-10
Study Status, Study Description, Outcome Measures v1
Primary endpoints2 entries, revised
FunctionalResting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)
Study description+30 characters
[...] be represented by resting-state functional connectivities. WeThe investigators aim to develop a TMS method targeting special brain circuit [...] s efficacy in SSD has not been evaluated. In this protocol, wethe investigators will compare them in patients with schizophrenia spectrum disorders.
2022-03-02
Original filing
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.
Trial Details
NCT Number NCT05276050
Lead Sponsor The University of Texas Health Science Center, Houston
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Smoking Cessation, Nicotine Addiction, Schizophrenia
Enrollment 50 participants
Start Date 2022-06-01
Primary Completion 2027-02-15 (estimated)
Study Completion 2028-02-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-16