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Effectiveness of Melatonin in managing sleep impairment in Opioid withdrawal patients

Melatonin as an adjuvant in managing sleep impairment in Opioid withdrawal patients- A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042865
Enrollment
40
Registered
2022-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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: Melatonin as an adjuvant in managing sleep impairement in opioid withdrawal patients
A Randomised Controlled Trial: All inpatients diagnosed with opioid dependence syndrome fulfilling the inclusion and exclusion criteria were randomised in two groups namely "the melatonin group" and

Sponsors

Sri Guru Ram Rai Institute of Medical and Health Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of Opioid Dependence Syndrome 2. Patients willing to give informed written consent. 3. Age of patient between 18 to 50 Years.

Exclusion criteria

Exclusion criteria: 1)Patients with other psychiatric comorbidities 2)Patients with other co-morbid debilitating illnesses 3)Patients with history of preexisting Sleep disorders (RLS , OSA, Insomnia and other sleep related disorders)   4). Patients kept on opioid agonist Treatment

Design outcomes

Primary

MeasureTime frame
For assessing improvement in sleep impairement in opioid withdrawal patients,following scales to be used Psqi(PITTSBURGH SLEEP QUALITY INDEX),Isi(INSOMNIA SEVERITY INDEX), Cows(CLINICAL OPIOID WITHDRAWAL SCALE),Cgis(CLINICAL GLOBAL IMPRESSION SCALE)Timepoint: Following scales Psqi(Pittsburgh Sleep Quality Index),Isi(Insomnia Severity Index), Cows(Clinical Opioid Withdrawal Scale),Cgis(Clinical Global Impression Scale) will be applied for study Of sleep impairement On Day 1,3,7 And 14 after recieving Melatonin—

Secondary

MeasureTime frame
To compare the adverse effects of adjunctive treatmentTimepoint: COWS and CGI scales will be applied at 1, 3 ,7 and 14 days—

Countries

India

Contacts

Public ContactTaniya Garg

Sri Guru Ram Rai Institute of Medical and Health Sciences

dhyani.mohan@gmail.com9997688192

Outcome results

None listed

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