Opioid DependencePhase 3NCT02516436
The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
A Phase 3 study testing BEMA Buprenorphine NX and Buprenorphine in people with Opioid Dependence, run by BioDelivery Sciences International at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- BEMA Buprenorphine NX and Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento 1 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Birmingham, Alabama, 35215
Study site
Orem, Utah, 84508
Study site
Salt Lake City, Utah, 84106
About this study
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
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.
Read the 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.
- Conditions
- Opioid Dependence
- Being tested
- BEMA Buprenorphine NX, Buprenorphine
- Keywords
- Bunavail, Suboxone, Heroin, Zubsolv, Buprenorphine, Naloxone, Opioids, Addiction, Induction
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEMA Buprenorphine NXDrug
Also called Bunavail
Buprenorphine with naloxone
BuprenorphineDrug
Buprenorphine
| Study group | Role | What they receive |
|---|---|---|
| BEMA Buprenorphine NX | Experimental | Buprenorphine with naloxone in a buccal film Receives: Drug: BEMA Buprenorphine NX |
| Buprenorphine | Active comparator | Buprenorphine in a buccal film Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in COWS total score for BEMA Buprenorphine NX vs BEMA Buprenorphine NX Control
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
Measured: At 12 hours post inital dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Primary completion1 May 2017
- Study completion1 May 2017
Why it stopped: FDA did not require a clinical trial for indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James G Sullivan, MD, Principal investigator, Parkway Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516436
- Sponsor's protocol ID
- BNX-302
- Status last verified
- May 2017
- First submitted
- 3 Aug 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02516436
- Acronym / sponsor ID
- BNX-302
- Conditions
- Opioid Dependence
- Keywords
- Bunavail, Suboxone, Heroin, Zubsolv, Buprenorphine, Naloxone, Opioids, Addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA did not require a clinical trial for indication.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEMA Buprenorphine NX | Experimental | Drug: BEMA Buprenorphine NXBuprenorphine with naloxone in a buccal film |
| Buprenorphine | Active comparator | Drug: BuprenorphineBuprenorphine in a buccal film |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEMA Buprenorphine NXAlso: BunavailBuprenorphine with naloxone | Drug | BEMA Buprenorphine NX |
| BuprenorphineBuprenorphine | Drug | Buprenorphine |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James G Sullivan, MD principal investigator
Parkway Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BEMA Buprenorphine NX and Buprenorphine in people with Opioid Dependence, run by BioDelivery Sciences International at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in COWS total score for BEMA Buprenorphine NX vs BEMA Buprenorphine NX Control (time frame: At 12 hours post inital dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.