Opioid DependencePhase 3NCT01713803
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
A Phase 3 study testing Buprenorphine and naloxone in people with Opioid Dependence, run by BioDelivery Sciences International at 1 site in United States.
Trial summary
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Buprenorphine and naloxone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained prior to any study procedure being performed
- Subject is a male or non-lactating female with a negative urine pregnancy test
- Subject is aged 18 to 65 years, inclusive
- Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria including physical dependence on opioids
- Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for at least 12 hours prior to Screening with positive opiate result on urine drug screen
- Clinical opioid withdrawal scale (COWS) score ≥9
- Subject is in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.
Who cannot join
- Use of a long-acting opioid within the last 72 hours
- Use of an investigational drug or device within the last 30 days
- History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
- Immediate 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 eC-SSRS
- History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the eC-SSRS
- 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
1 site in 1 country.
About this study
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.
- Conditions
- Opioid Dependence
- Being tested
- Buprenorphine and naloxone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine and naloxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Drug: Buprenorphine and naloxone |
| buprenorphine and nalaxone | Experimental | Not described Receives: Drug: Buprenorphine and naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose
Secondary outcomes (2)
The percentage of subjects with a negative result on the urine drug screen at Day 7
The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713803
- Sponsor's protocol ID
- BNX-350
- Status last verified
- May 2017
- First submitted
- 19 Oct 2012
- 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
- Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
- ClinicalTrials.gov ID
- NCT01713803
- Acronym / sponsor ID
- BNX-350
- Conditions
- Opioid Dependence
- 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
- 25 Oct 2012 (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.
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Buprenorphine and naloxone |
| buprenorphine and nalaxone | Experimental | Drug: Buprenorphine and naloxone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent obtained prior to any study procedure being performed
- Subject is a male or non-lactating female with a negative urine pregnancy test
- Subject is aged 18 to 65 years, inclusive
- Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria including physical dependence on opioids
- Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for at least 12 hours prior to Screening with positive opiate result on urine drug screen
Key exclusion criteria (7 listed)
- Use of a long-acting opioid within the last 72 hours
- Use of an investigational drug or device within the last 30 days
- History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
- Immediate suicidal risk, as determined by meeting any of the following:
- 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
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 |
|---|---|---|
| Buprenorphine and naloxone | Drug | Sugar pill, buprenorphine and nalaxone |
Primary outcome
The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose
2 secondary outcomes
The percentage of subjects with a negative result on the urine drug screen at Day 7
The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine and naloxone in people with Opioid Dependence, run by BioDelivery Sciences International at 1 site 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 7 inclusion and 7 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 1 site 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. Some participants in this study may receive a placebo. 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?
The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial 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.