A clinical trial to compare between Buprenorphine transdermal patch v/s sublingual tablet in the management of acute withdrawal symptoms of opioid use disorder.

Efficacy of transdermal v/s sublingual Buprenorphine in management of Opioid Detoxification : An open labelled Randomised Control Trial - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073669

Enrollment

Registered

2024-09-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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: Transdermal Buprenorphine patch: Transdermal Buprenorphine patch (5mg/10mg/20mg) for 7 days of opioid detoxification Control Intervention1: Sublingual Buprenorphine tablet: Sublingual B

Eligibility

Inclusion criteria

Inclusion criteria: Adult males or females with ICD-10 diagnosis of F12.3 i.e. Mental and Behavioral disorders due to use of opioids - Withdrawal state, admitted in the inpatient department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, and admitted in deaddiction centres in and around Bhubaneswar, who have given written consent for participation in the study.

Exclusion criteria

Exclusion criteria: Patients opting for non-opioid based detoxification. Patients with debilitating medical illness where buprenorphine cannot be used Patients with coexisting other substance use in dependent pattern(except Nicotine dependence)

Design outcomes

Primary

Measure	Time frame
Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification periodTimepoint: Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification period	—

Secondary

Measure	Time frame
a)Reduction in Subjective Opiate Withdrawal Scale (SOWS) score b)Monitoring of adverse drug reactions of Buprenorphine c)Requirement of additional medicationsTimepoint: Daily assessment	—

Countries

India

Contacts

Public ContactJayaprakash Russell Ravan

Kalinga Institute of Medical Sciences, Bhubaneswar

jpr_219@yahoo.co.in8763213999

Outcome results

None listed

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