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

May 2, 2017 updated by: BioDelivery Sciences International

A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. The study includes a Screening period of up to 3 days and a 2-day, double blind induction phase (subjects confined to the clinic). Screening and the first day of treatment (Day 1) may occur on the same day or Screening may occur up to 3 days prior to Day 1.

Opioid dependent subjects who provide informed consent at the Screening visit; have a Clinical Opiate Withdrawal Scale (COWS) total score ≥12; and meet other entry criteria are eligible for enrollment into the study. Subjects will be confined to the clinic beginning on Day 1 (optional confinement on Day -1) and will remain there for up to 48 hours after administration of the first study drug dose.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35215
    • Utah
      • Orem, Utah, United States, 84508
      • Salt Lake City, Utah, United States, 84106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent obtained prior to any study procedure being performed
  2. Pre-specified plan for continued treatment following study participation
  3. 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.
  4. Subject is aged 18 to 55 years, inclusive
  5. Current diagnosis of opioid substance use disorder per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5)
  6. Clinical opioid withdrawal scale (COWS) total score ≥12 prior to dosing on Day 1
  7. Subject is otherwise in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.
  8. Subject is committed to getting help for their opioid dependence, in the judgment of the Investigator.
  9. Subject has at least 1 verified contact.

Exclusion Criteria:

  1. Inability to meet study participation requirements, including a stay of up to 2 nights in the clinic
  2. Positive buprenorphine or methadone result on urine drug screen at Screening or Baseline
  3. Concurrent Diagnostic and Statistical Manual of Mental Disorders - 5th edition diagnosis of substance use disorder (excluding opioids and tobacco)
  4. Prolonged QT interval by medical history, family history, or current electrocardiogram (ECG) finding
  5. History of clinically significant hepatic impairment as determined by the Investigator.
  6. Use of any medication, nutraceutical or herbal product with CYP3A4 inhibition or induction properties within the past 30 days. This exclusion also extends to grapefruit juice and grapefruit juice-containing products as well as St. John's wort and St. John's wort-containing products (prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal supplements).
  7. Use of an investigational drug or device within the last 30 days
  8. History of hypersensitivity, allergy, or intolerance to buprenorphine or naloxone
  9. 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)
  10. Lack of motivation or a pattern of prior poor response to treatment, as judged by the investigator
  11. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEMA Buprenorphine NX
Buprenorphine with naloxone in a buccal film
Buprenorphine with naloxone
Other Names:
  • Bunavail
Active Comparator: Buprenorphine
Buprenorphine in a buccal film
Buprenorphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in COWS total score for BEMA Buprenorphine NX vs BEMA Buprenorphine NX Control
Time Frame: At 12 hours post inital dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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