Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a diagnosis of moderate to severe Heroin use disorder by the Diagnostic and Statistical Manual of Mental Disorders -5 (DSM-5) 2. Score greater than or equal to 4 on VAS 3. Providing written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with neurological disorders like multiple sclerosis, stroke, epilepsy, encephalopathy due to any cause 2. Patients with a history of significant head injury, brain tumour or any brain surgery 3. Patients with primary psychotic or mood disorder or other substance use disorder except nicotine 4. Pregnant and lactating females 5. Any electronic or metal implants 6. Any contraindications for TMS as assessed by the TMS Adult Safety Screen (TASS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in subjective report of craving measured using the Desire for Drug Questionnaire (DDQ) and Verbal Analogue Scale (VAS)Timepoint: Assessments will be performed at baseline (Day 0), Immediately after the end of 20 twice-daily rTMS sessions (Day 10), and at 4 weeks, i.e., 28 days after the termination of rTMS course (Day 38) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in an objective measure of craving using heroin visual image cue-elicited HRV measures, consumption of heroin measured using timeline follow back (TLFB), decision-making abilities and response inhibition assessed on CGT and SST, respectively.Timepoint: Secondary endpoint (Day 38): 4 weeks i.e., 28 days after the termination of 20 rTMS sessions | — |
Countries
India
Contacts
Postgradute Institute of Medical Education and Research