| CTRI Number |
CTRI/2024/09/073669 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare between Buprenorphine transdermal patch v/s sublingual tablet in the management of acute withdrawal symptoms of opioid use disorder. |
|
Scientific Title of Study
|
Efficacy of transdermal v/s sublingual Buprenorphine in management of Opioid Detoxification : An open labelled Randomised Control Trial
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Titas Chaudhuri |
| Designation |
Post graduate resident |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Research chamber, Department of Psychiatry, Kalinga Institute of Medical Sciences, Campus 5, KIIT University, Bhubaneswar, Odisha 751024
same as address 1
Khordha
ORISSA
751024
India |
| Phone |
9088211967 |
| Fax |
|
| Email |
titasch17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayaprakash Russell Ravan |
| Designation |
Professor of Psychiatry |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Unit 1, Department of Psychiatry, Kalinga Institute of Medical Sciences, Campus 5, KIIT University, Bhubaneswar, Odisha 751024
Same as address 1
Khordha
ORISSA
751024
India |
| Phone |
8763213999 |
| Fax |
|
| Email |
jpr_219@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jayaprakash Russell Ravan |
| Designation |
Professor of Psychiatry |
| Affiliation |
Kalinga Institute of Medical Sciences, Bhubaneswar |
| Address |
Unit 1, department of Psychiatry, Kalinga Institute of Medical Sciences, Campus 5, KIIT University, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
8763213999 |
| Fax |
|
| Email |
titasch17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences, Campus 5, KIIT University, Bhubaneswar, Odisha; Pin code -751024 |
|
|
Primary Sponsor
|
| Name |
Titas Chaudhuri |
| Address |
Kalinga Institute of Medical Sciences, Campus 5, KIIT University, Bhubaneswar, Odisha; Pin code -751024 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Titas Chaudhuri |
Chetana deaddiction centre |
Plot 502, Kanan Vihar, Patia, Bhubaneswar, Odisha 751031
Khordha
ORISSA |
9088211967
titasch17@gmail.com |
| Titas Chaudhuri |
Kalinga Institute of Medical Sciences |
Research chamber, Unit 1, Department of Psychiatry, Kalinga Institute of Medical Sciences, Campus 5, KIIT University, Bhubaneswar, Odisha 751024.
Khordha
ORISSA |
9088211967
titasch17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONA ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sublingual Buprenorphine tablet |
Sublingual Buprenorphine tablet (0.4mg-2mg/day) for 7 days of opioid detoxification |
| Intervention |
Transdermal Buprenorphine patch |
Transdermal Buprenorphine patch (5mg/10mg/20mg) for 7 days of opioid detoxification |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification period |
Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Reduction in Subjective Opiate Withdrawal Scale (SOWS) score
b)Monitoring of adverse drug reactions of Buprenorphine
c)Requirement of additional medications |
Daily assessment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open-label, randomized, parallel group trial to compare the efficacy of transdermal buprenorphine patch v/s sublingual buprenorphine tablets in the management of opioid detoxification in 60 patients with ICD-10 diagnosis of F11.3 Mental and behavioral disorders due to use of opioids, withdrawal state that will be conducted in Kalinga Institute of Medical Sciences, Bhubaneswar and in some deaddiction/rehabilitation centers in and around Bhubaneswar. The primary outcome measures will be daily assessment of reduction in Clinical Opiate Withdrawal Scale scores in both groups over 7 days. The secondary outcome measures will be daily assessment of reduction in Subjective Opiate Withdrawal Scale scores, daily assessment of adverse drug reactions of buprenorphine and requirement of additional medications in both groups over 7 days. |