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Trial record 49 of 194 for:    BUPRENORPHINE AND NALOXONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02516436
Recruitment Status : Withdrawn (FDA did not require a clinical trial for indication.)
First Posted : August 5, 2015
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

Tracking Information
First Submitted Date  ICMJE August 3, 2015
First Posted Date  ICMJE August 5, 2015
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02516436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
Official Title  ICMJE A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Opioid Dependence
Intervention  ICMJE
  • Drug: BEMA Buprenorphine NX
    Buprenorphine with naloxone
    Other Name: Bunavail
  • Drug: Buprenorphine
    Buprenorphine
Study Arms  ICMJE
  • Experimental: BEMA Buprenorphine NX
    Buprenorphine with naloxone in a buccal film
    Intervention: Drug: BEMA Buprenorphine NX
  • Active Comparator: Buprenorphine
    Buprenorphine in a buccal film
    Intervention: Drug: Buprenorphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 2, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2015)
40
Actual Study Completion Date  ICMJE May 1, 2017
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02516436
Other Study ID Numbers  ICMJE BNX-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BioDelivery Sciences International
Study Sponsor  ICMJE BioDelivery Sciences International
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James G Sullivan, MD Parkway Medical Center
PRS Account BioDelivery Sciences International
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP