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Trial record 48 of 186 for:    BUPRENORPHINE AND NALOXONE

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

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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Recruitment Status : Withdrawn (FDA did not require a clinical trial for indication.)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

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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: BEMA Buprenorphine NX Drug: Buprenorphine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BEMA Buprenorphine NX
Buprenorphine with naloxone in a buccal film
Drug: BEMA Buprenorphine NX
Buprenorphine with naloxone
Other Name: Bunavail

Active Comparator: Buprenorphine
Buprenorphine in a buccal film
Drug: Buprenorphine
Buprenorphine




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516436


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35215
United States, Utah
Orem, Utah, United States, 84508
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
BioDelivery Sciences International
Investigators
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Principal Investigator: James G Sullivan, MD Parkway Medical Center

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Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT02516436     History of Changes
Other Study ID Numbers: BNX-302
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by BioDelivery Sciences International:
Bunavail
Suboxone
Heroin
Zubsolv
Buprenorphine
Naloxone
Opioids
Addiction
Induction
Additional relevant MeSH terms:
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Buprenorphine
Naloxone
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists