Health Condition 1: null- Opioid Dependent
Conditions
Interventions
Intervention1: Xprenor (buprenorphine oral lyophilisate): 2 mg to 4 mg daily (Initial Dose) for 7 days
[Increase by 2-6mg daily based on patient response to a maximum of 24 mg/day]
Mode of Administr
Sponsors
Martindale Pharma
Clinigene International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical condition: Opioid dependent patients, eligible for opioid substitution therapy. 2.Gender: Male or Female. 3. Age: 18 - 60 years (both inclusive). 4. BMI: 18.0 to 30.0 Kg/m2 5. Capable of providing voluntary informed consent. 6. Female patients who are sexually active will be of non-child bearing potential (i.e., surgically sterilized or postmenopausal), abstain from sexual intercourse, or use a reliable method of contraception (e.g. hormonal contraceptive, condom with spermicide, IUD) for at least 30 days prior to dosing and during the duration of the study.
Exclusion criteria
Exclusion criteria: 1.Current or previous (within previous 2 days) dependence treatment, e.g. buprenorphine or methadone. 2.Hypersensitivity to buprenorphine or any other component of the oral lyophilisate. 3.Positive urine drug test for cocaine or amphetamines at screening. 4.Severe hepatic insufficiency (defined as liver function tests, including alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, greater than three times the upper limit of normal). 5.Concomitant use of benzodiazepines, which may potentiate respiratory depression, above recommended therapeutic doses or patients who are not stabilized on benzodiazepine therapy. 6.Concomitant use of other central nervous system depressant, such as other opioid derivatives, certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances. 7.Concomitant use of monoamine oxidase inhibitors, which may aggravate opioid effects. 8.Administration of any approved or investigational long-acting injections of antipsychotic medications. 9.Current psychiatric diagnosis of major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the patientâ??s ability to complete the study. 10.Female patients with a positive pregnancy test, lactating mother, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial. 11.Participation in a clinical trial of a pharmacological agent within 6 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare Oxygen desaturation as measured by pulse oximetry 2.To monitor respiration rate 3.To compare the incidence of AEs and SAEs reported in Subutex (buprenorphine hydrochloride) and Xprenor (Buprenorphine oral lyophilisate) armsTimepoint: Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate and compare the reduction in opioid withdrawal symptoms 2.To evaluate and compare the reduction in scores on the Objective and Subjective Opioid Withdrawal Scale 3.To determine the satisfaction of treatment using a dose adequacy (Likert) scaleTimepoint: Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14 | — |
Countries
India
Contacts
Public ContactDr Anand Eswaraiah
Clinigene International Ltd. Bangalore
Outcome results
None listed