Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Intervention1: THETA FREQUENCY HD tACS -ACTIVE: Theta frequency HD- tACS will be administered using a standard equipment (Starstim-32, Neuroelectrics BE, Spa.) using stringent safety measures. The sit
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1. In-patient male sex, right handed individuals aged between 18-50 years. 2. Those who fulfill the criteria for Mental and Behavioral disorders due to use of Opioids, Dependence syndrome (F11.2X) according to International Classification of Diseases 10th version (ICD-10)- Diagnostic Criteria for Research (DCR) by World Health Organization in 1993. 3. Drug free or drug naïve patients. 4. Patients without any co morbid substance dependence (except Nicotine and Caffeine). 5. Patients without any co morbid psychiatric disorders. 6. Subjects giving written informed consent. 7. Patients being detoxified with symptomatic management.
Exclusion criteria
Exclusion criteria: 1. Female sex 2. Aged below 18 years and above 50 years. 3. Patients with currently serious medical problem, complicated withdrawal (seizure, delirium) and organic brain disorder. 4. History of any other psychiatric illness or mental retardation. 5. Subjects not willing to give written informed consent. 6. Patients having any metallic implants/parts in body. 7. Patients detoxified with an anti-craving or opioid agonist during period of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Primary outcome is change in craving in patients with opioid dependence assessed by DDQ. 2.Primary outcome is change in craving in patients with opioid dependence assessed by OCDUS. 3.Primary outcome is change in withdrawal in patients with opioid dependence assessed by COWS. Timepoint: 1.change in DDQ measured on Days 2,8,23 2. change in craving assessed by OCDUS measured on Days 2,8,23 3.change in withdrawal assessed by COWS measured on Days 1,2,3,4,5,6,7 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secondary outcome is change in resting state functional connectivity of large scale brain networks like the ECN and SN among patients with opioid dependence. 2. Secondary outcome is change in cue related functional connectivity of large scale brain networks like the ECN and SN among patients with opioid dependence. 3. Secondary outcome is change is CGI-I scores from baseline to end in patients with opioid dependence assessed by CGI-I Scale. 4. Number of days to reach COWS score below 5. Timepoint: 1.change in resting state functional connectivity of large scale brain networks like the ECN and SN measured on day 2,8 2. change in cue related functional connectivity of large scale brain networks like the ECN and SN measured on day 2,8 3.change in CGI-I scores from baseline to end assessed by CGI-I Scale on days 1,8,23. 4.Number of days to reach COWS score below 5. | — |
Countries
India
Contacts
Public ContactSourav Khanra
Central Institute of Psychiatry
Outcome results
None listed