A clinical study to compare safety and efficacy of two brands of buprenorphine (XPRENOR and SUBUTEX) in patients who are opioid dependent.

Phase 2

Completed

• Conditions: Health Condition 1: null- Opioid Dependent

• Registration Number: CTRI/2013/06/003782
• Lead Sponsor: Martindale Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified