NCT03281629

Circuitry-Guided Smoking Cessation in Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Smoking Cessation
• Nicotine Addiction
• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Active TMS stimulation	Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
DEVICE	Sham TMS stimulation	Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.

Timeline

• Start date: 2018-10-19
• Primary completion: 2021-02-28
• Completion: 2022-02-15
• First posted: 2017-09-13
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study