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Opioid DependencePhase 2NCT01666119

An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects

A Phase 2 study testing BEMA Buprenorphine NX films in people with Opioid Dependence, run by BioDelivery Sciences International at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine/naloxone) tablets… 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?
BEMA Buprenorphine NX films
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
10 sitesUnited States
Study dates
Aug 2012to Jan 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Written informed consent obtained at Screening, prior to any study procedure being performed
  • 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 65 years of age, inclusive
  • Diagnosis of opioid dependence per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria in the past 12 months including physical dependence on opioids and addiction with compulsive use despite harm
  • Currently taking a stable, single daily dose of 16/4 to 32/8 mg Suboxone tablets or films (buprenorphine/naloxone) for at least 30 days
  • Subject is in good general health; with no clinically significant findings on medical history, physical examination, safety laboratory test and ECG in the judgment of the investigator at screening. Serum creatinine, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) values must be within 3-times the upper limit of normal (ULN). Pulse oximetry must be ≥96%, systolic blood pressure ≥110 mmHg, and diastolic blood pressure ≥65 mmHg.

Who cannot join

  • Hypokalemia, hypomagnesemia, or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or clinically significant arrhythmias
  • History of Long QT Syndrome, or an immediate family member with this condition
  • Currently taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone, dofetilide)
  • Uncontrolled hypertension defined as systolic blood pressure >170 mmHg and diastolic blood pressure >90 mmHg at Baseline
  • Pulse oximetry ≤93% at Baseline, regardless of cause
  • Clinically significant abnormality on 12-lead ECG, including a QTc interval >490 milliseconds
Show all 17Show fewer
  • Use of any medication, nutraceutical or herbal product with CYP3A4 inhibition or induction properties within the past 30 days (see Appendix 4 for a list of applicable drugs). 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).
  • Diagnosis of moderate to severe hepatic impairment
  • Use of an investigational drug or device within the last 30 days
  • Participation in a previous clinical study of BEMA Buprenorphine NX or BEMA Buprenorphine
  • History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
  • Pierced tongue or mouth
  • Any clinically significant abnormality of the buccal mucosa which could impact drug absorption
  • 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

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Belvidere, New Jersey, 07823

  • Study site

    Birmingham, Alabama, 35215

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Haleyville, Alabama, 35565

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Maitland, Florida, 32751

  • Study site

    North Miami, Florida, 33161

  • Study site

    Prairie Village, Kansas, 66206

  • Study site

    Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects (BNX-201)

This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized on Suboxone (buprenorphine/naloxone) tablets or films.

Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs).

Read the detailed description

This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films.

Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX. This dose will be taken throughout the 12-week treatment period with dose adjustments as clinically indicated for either the control of opioid dependence or adverse events (AEs). Subjects will be monitored for evidence of buccal irritation attributed to the application of the BEMA Buprenorphine NX film and opioid dependence control according to the Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction - A Treatment Improvement Protocol (TIP 40) guidelines for the use of buprenorphine in the management of opioid dependence.

The total duration of participation for each subject will be up to approximately 18 weeks and includes a Screening period (subjects continue to take Suboxone tablets or films), Baseline visit, a 12-week open label treatment period (subjects take BEMA Buprenorphine NX films and at the Day 84 visit, subjects will return to their prior Suboxone treatment), and a Follow-up Visit.

Vital signs, pulse oximetry, opioid withdrawal symptoms, adverse events (AEs), oral examinations, and concomitant medications will be assessed at intervals throughout the study. Clinical laboratory assessments, urine toxicology and buprenorphine testing, and 12-lead electrocardiograms (ECGs) will also be performed.

Being tested
BEMA Buprenorphine NX films
Keywords
Opioid dependence, Suboxone, addiction, BEMA Buprenorphine NX, oral transmucosal
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 NX filmsDrug

    Also called BNX

    BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.

Study groups in NCT01666119
Study groupRoleWhat they receive
BEMA Buprenorphine NX filmsExperimentalBEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
Receives: Drug: BEMA Buprenorphine NX films

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.

    Measured: 12 weeks

Secondary outcomes (1)

  1. Urine Drug Screen

    Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01666119
Sponsor's protocol ID
BNX-201
Status last verified
Feb 2017
First submitted
13 Aug 2012
Last updated
4 Apr 2017
Data monitoring committee
No
Individual data sharing
No

Publications

  • Sullivan JG, Webster L. Novel Buccal Film Formulation of Buprenorphine-Naloxone for the Maintenance Treatment of Opioid Dependence: A 12-Week Conversion Study. Clin Ther. 2015 May 1;37(5):1064-75. doi: 10.1016/j.clinthera.2015.02.027. Epub 2015 Mar 29.

    PubMed 25823919

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEMA Buprenorphine NX films in people with Opioid Dependence, run by BioDelivery Sciences International at 10 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01666119, which also lists 1 linked publication.

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 Apr 2017.

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