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To measure reduction in craving in patients with opioid dependence as measured by MRS by giving adjunctive intranasal oxytocin

Efficacy of Adjunctive Intranasal Oxytocin on Craving in Patients with Opioid Dependence: An 1H-MRS Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/083806
Enrollment
50
Registered
2025-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: Naltrexone and Intranasal Oxytocin: When the COWS is less than 5, patient will be rated on OCDUS, DDQ, RODS and MRS of Medial Prefrontal Cortex will be done. Patient will receive Naltre

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA 1. Those who fulfil the criteria for Disorder due to use of opioids, Opioid dependence current use using Clinical descriptions and diagnostic requirements for ICD-11 mental, behavioural and neurodevelopmental disorders (CDDR) (ICD-11 CDDR, World Health Organization, 2019). 2. In-patient male sex, right-handed individuals aged between 18-60 years. 3. Subjects giving written informed consent. 4. Patients to be selected post detoxification.

Exclusion criteria

Exclusion criteria: EXCLUSION CRITERIA 1. Patients with currently serious medical problem and organic brain disorder. 2. Significant medical or neurological illness including severe cardiovascular, hepatic, renal, (serum creatinine more than 1.5 mg per dl), anaemia (Haemoglobin less than 11 mg per dl), or myopathy or untreated thyroid disease. 3. Allergic rhinitis or other inflammation of nasal mucosa for past 6 months 4. Patients with any co morbid substance dependence with opioid (except Nicotine and Caffeine) 5. History of any other psychiatric illness or mental retardation 6. Subjects not willing to give written informed consent. 7. Patients having any metallic implants or parts in body. 8. Patient received any form of NIBS in last three month. 9. Patients having withdrawal symptoms.

Design outcomes

Primary

MeasureTime frame
Change in craving in patients with opioid dependence assessed by DDQ, OCDUS, COWS.Timepoint: Reduction in scores of OCDUS, DDQ and COWS at baseline and after 2 weeks—

Secondary

MeasureTime frame
Change in glutamate levels in mPFC and change in depressive and anxiety symptoms as measured by HAM-D and HAM-A scales respectively.Timepoint: To measure change in glutamate levels in mPFC and change in depressive and anxiety symptoms as measured by HAM-D and HAM-A scales respectively at baseline and 2 weeks—

Countries

India

Contacts

Public ContactDr Anjanik Kumar Rajan

Central Institue of Psychiatry

dranjanikkumarcip@gmail.com7766817961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026