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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02516436
• Date of registration: 03/08/2015
• Prospective Registration: Yes
• Primary sponsor: BioDelivery Sciences International
• Public title: The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
• Scientific title: A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
• Date of first enrolment: December 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02516436
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: James G Sullivan, MD
• Affiliation: Parkway Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Opioid Dependence

Intervention(s)

Drug: BEMA Buprenorphine NX

Drug: Buprenorphine

Primary Outcome(s)

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

Secondary ID(s)

BNX-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors