| CTRI Number |
CTRI/2024/02/063348 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying How Certain Genes Affect the Success of Medications (Buprenorphine and Naloxone) for Opioid Addiction Treatment |
|
Scientific Title of Study
|
Genetic polymorphism and treatment outcomes in opioid use disorder patients: A study of OPRD1 and OPRM1 variants in Buprenorphine and Naloxone pharmacotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Medhi |
| Designation |
Professor, Department of Pharmacology, PGIMER |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Room No- 4043,
Dept of Pharmacology
Research Block-B,
PGIMER,
Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207510 |
| Fax |
|
| Email |
drbikashus@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Medhi |
| Designation |
Professor, Department of Pharmacology, PGIMER |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Room No- 4043,
Dept of Pharmacology
research block-B,
PGIMER,
Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207510 |
| Fax |
|
| Email |
drbikashus@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Adarsh M V |
| Designation |
Junior resident, Department of Pharmacology, PGIMER |
| Affiliation |
Post graduate institute of medical education and research, Chandigarh |
| Address |
Room No- 4045,
Dept of Pharmacology
research block-B,
PGIMER,
Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7008560493 |
| Fax |
|
| Email |
drmvadarsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER(post graduate institute of medical education and research, Chandigarh) |
|
|
Primary Sponsor
|
| Name |
PGIMER, Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh, pin 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Bikash Medhi |
PGIMER |
Room No-104,DDTC,Department of Psychiatry, PGIMER, sector 12, Chandigarh, India, pin 160012
Chandigarh
CHANDIGARH |
9914207510
drbikashus@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(intramural), PGIMER |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-65 years, Either gender, Diagnosis of moderate or severe OUD as per DSM-V criteria or opioid dependence as per ICD-11, Providing written informed consent, Participants within a week of initiating buprenorphine naloxone (BNX) treatment.
|
|
| ExclusionCriteria |
| Details |
Presence of cardiomyopathy, Patients with liver disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment retention- time in weeks until buprenorphine/naloxone treatment discontinuation |
assessed every week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of negative urine screen for opioids other than buprenorphine, Mean daily dose of buprenorphine(buprenorphine and naloxone), Adverse effects associated with buprenorphine
|
assessed every month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aim:
To assess pharmacogenetic factors related to
buprenorphine/naloxone treatment response in opioid use disorder patients.
Primary objective:
To compare treatment retention between OPRD1 and OPRM1
variants.
Secondary objectives:
Compare the proportion of negative urine drug screens
Compare the mean daily dose requirements
Analyse adverse effects of buprenorphine/naloxone
Methodology:
Sample size: 420 participants meeting inclusion and
exclusion criteria.
Study site: Conducted at PGIMER, Chandigarh, India, in
collaboration with the Pharmacology and Psychiatry departments.
Design: Prospective observational study.
Plan:
Select participants and obtain consent.
Screen and exclude if needed.
Genotype blood samples.
Weekly adherence follow-up.
Urine screening for non-buprenorphine opioids during
treatment.
Monitor adverse effects.
Sampling: Draw 5 mL venous blood via IV catheters. Collect
monthly urine samples in sterile containers.
Outcomes:
Primary outcome: Treatment retention
Secondary outcomes: Proportion of negative urine drug
screens for relapse, mean daily buprenorphine dose, percentage of
buprenorphine-associated adverse effects.
Statistical Evaluation: Conduct appropriate statistical
analysis to identify significant associations between pharmacogenomic variants
and treatment outcomes. |