Using magnetic brain stimulation to help people with schizophrenia stop tobacco use

Efficacy and feasibility of deep rTMS as tobacco cessation aid in patients with schizophrenia: a double blind, sham controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100489

Enrollment

Registered

2026-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F172- Nicotine dependence Health Condition 2: F25- Schizoaffective disorders Health Condition 3: F20- Schizophrenia

Interventions

Intervention1: Deep rTMS using H4 coil: TMS Procedure Administration A total of 15 sessions will be administered over 5 days. Each TMS session will be administered by individual(s) trained in delive

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects meeting ICD-11 criteria for Schizophrenia or schizoaffective disorder and current CGI rating scale of less than or equal to 4. 2. Subjects meeting ICD-11 criteria for Nicotine dependence (smokeless as well as smoking) and who express desire to quit 3. Subjects who have intact capacity to make treatment related decisions and provide written informed consent 4. Negative urine toxicology screen for illicit substances

Exclusion criteria

Exclusion criteria: 1. Any history of mental illness other than schizophrenia/schizoaffective disorder in the past 1 year. 2. Any substance use disorder (other than tobacco) in the past 12 months 3. History of epilepsy 4. Clinical Global Impression (CGI) Rating Scale rating of 6 (severely ill) and or 7 (extremely ill) 5. Pregnancy or lactation (in case of women) 6. Lack of capacity or refusal to give informed consent

Design outcomes

Primary

Measure	Time frame
7-day point prevalence tobacco abstinence at 4 weeks post treatmentTimepoint: 4 weeks post treatment	—

Secondary

Measure	Time frame
- 7-day point prevalence tobacco abstinence at 8 weeks post treatment - Biochemical verification of abstinence via Carbon Monoxide (CO) breath test - Change in tobacco craving pre- and post-treatment - Tobacco use trajectory over time (Timeline Follow Back method) namely time to first tobacco use and overall tobacco use (smokeless and smoking both) - Change in Brief Psychiatric Rating Scale (BPRS) scores (exploratory outcome) at week 4 and week 8 post treatment Timepoint: At each session - baseline (pre and post intervention) and 4 weeks and 8 weeks post completion of sessions	—

Measure

Time frame

- 7-day point prevalence tobacco abstinence at 8 weeks post treatment - Biochemical verification of abstinence via Carbon Monoxide (CO) breath test - Change in tobacco craving pre- and post-treatment - Tobacco use trajectory over time (Timeline Follow Back method) namely time to first tobacco use and overall tobacco use (smokeless and smoking both) - Change in Brief Psychiatric Rating Scale (BPRS) scores (exploratory outcome) at week 4 and week 8 post treatment Timepoint: At each session - baseline (pre and post intervention) and 4 weeks and 8 weeks post completion of sessions

—

Countries

India

Contacts

Public ContactJayant Mahadevan

National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru

jayantmahadevan@gmail.com9894162384

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026