NCT01666119

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 4, 2017

Completed
Last Updated

April 4, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

August 13, 2012

Results QC Date

February 2, 2015

Last Update Submit

February 13, 2017

Conditions

Opioid Dependence

Keywords

Opioid dependenceSuboxoneaddictionBEMA Buprenorphine NXoral transmucosal

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (1)

  • Urine Drug Screen

    12 weeks

Study Arms (1)

BEMA Buprenorphine NX films

EXPERIMENTAL

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.

Drug: BEMA Buprenorphine NX films

Interventions

BEMA Buprenorphine NX filmsDRUG

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.

Also known as: BNX
BEMA Buprenorphine NX films

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Birmingham, Alabama, 35215, United States

Location

Unknown Facility

Haleyville, Alabama, 35565, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Maitland, Florida, 32751, United States

Location

Unknown Facility

North Miami, Florida, 33161, United States

Location

Unknown Facility

Prairie Village, Kansas, 66206, United States

Location

Unknown Facility

Baltimore, Maryland, 21201, United States

Location

Unknown Facility

Fall River, Massachusetts, 02720, United States

Location

Unknown Facility

Belvidere, New Jersey, 07823, United States

Location

Unknown Facility

Salt Lake City, Utah, 84106, United States

Location

Related Publications (1)

  • 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.

    PMID: 25823919DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Results Point of Contact

Title
Enoch Bortey
Organization
BDSI
ebortey@bdsi.com
919 582 9050

Study Officials

  • Greg Sullivan, MD

    Parkway Medical

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 4, 2017

Results First Posted

April 4, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(10)