Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Age: 18-50 years. 2 Either sex. 3 A diagnosis of OUD as per DSM-5TR. 4 Maintained on a well-optimized dose of Buprenorphine for at least 12 weeks prior to the intervention period. 5 Persistent pain symptoms of intensity on Numerical Rating Scale (NRS) 1 to 10) for which further increase in buprenorphine dose is not possible due to poor tolerance (nausea, headache, sedation) OR patient refuses to increase the dose of buprenorphine further. 6 No change in medication is planned during one week of the tDCS treatment course (except for benzodiazepines) 7 Providing written informed consent
Exclusion criteria
Exclusion criteria: 1. The onset of pain symptoms prior to the onset of opioid use disorder 2. Pain due to secondary causes 3. Patients with primary psychotic or primary mood disorders. 4. Patients with a neurological disorder like multiple sclerosis, stroke, epilepsy, or encephalopathy due to any cause. 5. Patients with any intracranial metallic and electric implants. 6. Patients with comorbid organic brain syndrome and intellectual disability. 7. Patients with OUD associated with underlying organic illness. 8. Patients with comorbid substance use disorder (moderate to severe) except Nicotine 9. Contra-indications for TMS as reflected in the international safety guidelines which include metal implants in the face/skull, pacemaker, and primary seizure disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate what proportion of eligible study participants consent to the study, initiate tDCS sessions, continue at least 3 sessions, and complete all ten sessionsTimepoint: at the end of 3 session of tDCS and 10th session of tDCS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the effects of anodal tDCS and sham stimulation for reduction of pain – intensity, duration, and frequency 2. To compare the effects of anodal tDCS and sham stimulation on motor cortical excitability measures and examine the correlation between change in pain scores and change in motor cortical excitability. 3. To compare the frequency of adverse events in participants undergoing anodal tDCS and sham stimulation Timepoint: Assessment after the last or 10th stimulation session and reassessment after 1 month | — |
Countries
India
Contacts
PGIMER