| CTRI Number |
CTRI/2025/08/092948 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare effectiveness of buprenorphine film with buprenorphine tablet in those addicted to opioids |
|
Scientific Title of Study
|
An Open-Label trial assessing acceptability of Buprenorphine sublingual films |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Atul Ambekar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences DELHI |
| Address |
4090 B TEACHING BLOCK
All India Institute of Medical Sciences
NEW DELHI 110029
New Delhi
DELHI
110029
India |
| Phone |
9811155682 |
| Fax |
|
| Email |
atul.ambekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atul Ambekar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences DELHI |
| Address |
4090 B TEACHING BLOCK
All India Institute of Medical Sciences
NEW DELHI 110029
New Delhi
DELHI
110029
India |
| Phone |
9811155682 |
| Fax |
|
| Email |
atul.ambekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atul Ambekar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences DELHI |
| Address |
4090 B TEACHING BLOCK
All India Institute of Medical Sciences
NEW DELHI 110029
New Delhi
DELHI
110029
India |
| Phone |
9811155682 |
| Fax |
|
| Email |
atul.ambekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zim Laboratories Limited
Sadoday Gyan (Ground Floor), Opp. N.A.D.T, Nelson Square, Nagpur – 440013, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Zim Laboratories Limited |
| Address |
B-21/22 MIDC industrial Area, Kalmeshwar,
Nagpur-441501 Maharashtra, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Atul Ambekar |
National Drug Dependence Treatment Center, AIIMS, Delhi |
Room no. 308, Department of Addiction Psychiatry, NDDTC, Kamla Nehru Nagar, C.G.O. Complex, Ghaziabad - 201002
Ghaziabad
UTTAR PRADESH |
9811155682
ATUL.AMBEKAR@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMSDELHIIEC |
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 |
Test Product: Buprenorphine sublingual films 8/6/4 mg manufactured by Zim Laboratories Limited, Nagpur, India
|
Dose: 8/6/4/mg
Frequency: Once a day
Route of administration: Sublingual
Total duration of such intervention: 4 weeks
Buprenorphine was first approved in India as injectable in 1986 and as sublingual tablets in 1987. Later it was also approved as transdermal patches. As per the New Drugs and Clinical Trials Rules 2019, “Buprenorphine Sublingual films 8/6/4 mg” will fall under the category of “New Drugs”. This is a drug approved by the Central Licensing Authority as sublingual tablet dosage form and the sponsor eventually will seek approval for manufacturing and marketing of new sublingual dosage form (films), after the phase III trial. Thus, these sublingual films are the additional dosage form for the already approved sublingual tablets. |
| Comparator Agent |
Vernor-SL 2 Buprenorhine Sublingual Tablet 2mg manufactured by Verve Human Care Laboratories Ltd |
Dose: 8/6/4/mg
Frequency: Once a day
Route of administration: Sublingual
Total duration of such intervention: 4 weeks
This tablet is routinely used at all treatment centers to provide buprenorphine maintenance treatment to those with opioid dependence syndrome. It is used at the study site as a part of routine, standard care.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Adult male meeting criteria for opioid dependence as defined by the International Statistical Classification of Diseases and Related Health Problems eleventh edition who are an appropriate candidate for Opioid Agonist Maintenance Treatment with buprenorphine on a daily dispensing schedule and stabilized on a constant dose between 4 mg to 18 mg per day for a minimum period of one week and willing to remain on buprenorphine during the phase of the trial |
|
| ExclusionCriteria |
| Details |
1. Any known allergy, hypersensitivity or intolerance to BPN or NX or any related drug, or history of any drug hypersensitivity or intolerance which in the opinion of the Investigator, would compromise the safety of the patient or the trial.
2. Patients with serious oral lesions/pathology which makes sublingual film administration difficult.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Retention in treatment at 4 weeks
Negative urine drug screening for opioids at 4 weeks
• Subjective dose effects of buprenorphine films (craving, withdrawal, drug liking) (Weekly)
|
weekly visit upto 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Self-reported abstinence (Weekly)
Side effects & Adverse events (AEs) (Weekly)
• Ease of Handling & dispensing by healthcare providers
|
weekly visit upto 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an open label, prospective, randomized, study to assess acceptability of Buprenorphine sublingual films 8/6/4 mg in adult opioid dependence patients and in healthcare providers. Subjects with opioid dependence who meet all the eligibility criteria, based on medical history and clinical examination will be recruited in this study. After written informed consent, patients will be randomized to either of the two treatment arms: intervention arm i.e. Buprenorphine sublingual films or comparator arm i.e. continued treatment with Buprenorphine sublingual tablets, which represents treatment as usual. |