Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Intervention1: 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
Sponsors
Zim Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) Timepoint: weekly visit upto 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported abstinence (Weekly) Side effects & Adverse events (AEs) (Weekly) Ease of Handling & dispensing by healthcare providers Timepoint: weekly visit upto 4 weeks | — |
Countries
India
Contacts
Public ContactAtul Ambekar
All India Institute of Medical Sciences DELHI
Outcome results
None listed