Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects

NCT01713803 | Withdrawn Phase 3

• 1 other identifier: BNX-350
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose

Secondary Outcomes (2)

• The percentage of subjects with a negative result on the urine drug screen at Day 7

• The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Drug: Buprenorphine and naloxone

buprenorphine and nalaxone

EXPERIMENTAL

Drug: Buprenorphine and naloxone

Interventions

Buprenorphine and naloxone DRUG

Sugar pill; buprenorphine and nalaxone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained prior to any study procedure being performed
• Subject is a male or non-lactating female with a negative urine pregnancy test
• Subject is aged 18 to 65 years, inclusive
• Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria including physical dependence on opioids
• Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for at least 12 hours prior to Screening with positive opiate result on urine drug screen
• Clinical opioid withdrawal scale (COWS) score ≥9
• Subject is in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.

You may not qualify if:

• Use of a long-acting opioid within the last 72 hours
• Use of an investigational drug or device within the last 30 days
• History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
• Immediate suicidal risk, as determined by meeting any of the following:
• History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4 (intent to act) or 5 (specific plan and intent) on the eC-SSRS
• History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the eC-SSRS
• A history or current evidence of any clinically significant disorder or any other condition which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results

Sponsors & Collaborators

• BioDelivery Sciences International: lead

Study Sites (1)

Unknown Facility

Birmingham, Alabama, 35215, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 25, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)