The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects

NCT02516436 | Withdrawn Phase 3

• 1 other identifier: BNX-302
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic. Opioid dependent subjects who provide informed consent meet all entry criteria are eligible for enrollment into the study.

Conditions

Opioid Dependence

Keywords

Bunavail; Suboxone; Heroin; Zubsolv; Buprenorphine; Naloxone; Opioids; Addiction; Induction

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in COWS total score for BEMA Buprenorphine NX vs BEMA Buprenorphine NX Control

  To determine if induction of opioid dependent subjects with BEMA Buprenorphine NX results in more opioid withdrawal symptoms than induction with BEMA Buprenorphine NX Control

  At 12 hours post inital dose

Study Arms (2)

BEMA Buprenorphine NX

EXPERIMENTAL

Buprenorphine with naloxone in a buccal film

Drug: BEMA Buprenorphine NX

Buprenorphine

ACTIVE COMPARATOR

Buprenorphine in a buccal film

Drug: Buprenorphine

Interventions

BEMA Buprenorphine NX DRUG

Buprenorphine with naloxone

Also known as: Bunavail

BEMA Buprenorphine NX

Buprenorphine DRUG

Buprenorphine

Buprenorphine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent obtained prior to any study procedure being performed
• Pre-specified plan for continued treatment following study participation
• Male or non-pregnant and non-nursing female. A female of childbearing potential is eligible to participate in this study if she is not pregnant and is using an acceptable method of birth control.
• Subject is aged 18 to 55 years, inclusive
• Current diagnosis of opioid substance use disorder per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5)
• Clinical opioid withdrawal scale (COWS) total score ≥12 prior to dosing on Day 1
• Subject is otherwise in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.
• Subject is committed to getting help for their opioid dependence, in the judgment of the Investigator.
• Subject has at least 1 verified contact.

You may not qualify if:

• Inability to meet study participation requirements, including a stay of up to 2 nights in the clinic
• Positive buprenorphine or methadone result on urine drug screen at Screening or Baseline
• Concurrent Diagnostic and Statistical Manual of Mental Disorders - 5th edition diagnosis of substance use disorder (excluding opioids and tobacco)
• Prolonged QT interval by medical history, family history, or current electrocardiogram (ECG) finding
• History of clinically significant hepatic impairment as determined by the Investigator.
• Use of an investigational drug or device within the last 30 days
• History of hypersensitivity, allergy, or intolerance to buprenorphine or naloxone
• Increased 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 electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
• History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
• Lack of motivation or a pattern of prior poor response to treatment, as judged by the investigator
• 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 (3)

Unknown Facility

Birmingham, Alabama, 35215, United States

Location

Unknown Facility

Orem, Utah, 84508, United States

Location

Unknown Facility

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Interventions

Buprenorphine, Naloxone Drug Combination; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

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 Officials

• James G Sullivan, MD

  Parkway Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (3)