Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fulfil criteria for opioid dependence according to ICD 10 diagnostic system. 2. Opioids as the primary drug of use 3. Currently abstinent from opioids and maintained on Naltrexone for atleast 1 week. 4. Seeking treatment voluntarily, ready to give consent for participation in the study 5. Non-dependent use of other psychoactive substances.
Exclusion criteria
Exclusion criteria: 1. History of any psychiatric condition (assessed with M.I.N.I. screen (Mini International Neuropsychiatric Interview; ver. 7). 2. History of any neurological illness and neurological deficit on neurological examination. 3. History of epilepsy or seizure episode within last 1 year. 4. Current treatment with anti-epileptic medication. 5. History of any significant medical condition which will hamper inclusion in the study. 6. Currently in parole or probation, or pending legal proceedings with potential for incarceration. 7. Current dependent use of any other psychoactive substance (other than tobacco). 8. Current opioid use (urine ELISA positive for morphine, buprenorphine or dextropropoxyphene). 9. Patient experiencing acute withdrawal for opioids or any other psychoactive substance. 10. Patient under intoxication of any substance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of 17 sessions of EEG-based neurofeedback training on craving and protracted withdrawal symptoms between the intervention group and the the non-intervention group consisting of adult opioid-dependent subjects maintained on Naltrexone.Timepoint: Total of seven assessments for primary outcome will be done: 1. One assessment at baseline. 2. One assessment after 2 sessions of relaxation training. 3. Five more assessments, one assessment after every three session of neurofeedback training. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess acceptability of EEG-based neurofeedback training as add-on treatment modality among the subjects receiving 17 session of EEG-based neurofeedback training.Timepoint: Total of seven assessments for primary outcome will be done: 1. One assessment at baseline. 2. One assessment after 2 sessions of relaxation training. 3. Five more assessments, one assessment after every three session of neurofeedback training. | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Delhi