- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516436
The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35215
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Utah
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Orem, Utah, United States, 84508
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Salt Lake City, Utah, United States, 84106
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 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).
- 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
Study Plan
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
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Buprenorphine with naloxone
Other Names:
|
Active Comparator: Buprenorphine
Buprenorphine in a buccal film
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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
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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
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At 12 hours post inital dose
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Collaborators and Investigators
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
Other Study ID Numbers
- BNX-302
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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