Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence
1 other identifier
interventional
313
1 country
14
Brief Summary
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2013
Shorter than P25 for phase_3
14 active sites
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
First Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
June 24, 2015
CompletedMay 10, 2017
April 1, 2017
7 months
May 2, 2013
April 10, 2015
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention in Treatment in the Per Protocol Population
Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.
Day 3
Secondary Outcomes (7)
Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive
Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive
Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive
Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1
Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)
Predose on Days 4, 8, 15, 22, and 29
Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)
Pre-dose on Days 4, 8, 15, 22, and 29
- +2 more secondary outcomes
Study Arms (2)
BNX Sublingual Tablets Induction
EXPERIMENTALDay 1-2 (Blinded Induction): BNX sublingual tablets Day 3-28 (Open-label Maintenance): BNX sublingual tablets
Buprenorphine Induction
ACTIVE COMPARATORDay 1-2 (Blinded Induction): Generic buprenorphine sublingual tablets Day 3-28 (Open-label Maintenance): BNX sublingual tablets
Interventions
Advanced-formulation buprenorphine/naloxone sublingual tablets
Buprenorphine sublingual tablets
Eligibility Criteria
You may qualify if:
- Able to read, comprehend, and sign the informed consent form and willingly provide written informed consent
- Prepared to engage in opioid replacement therapy and to abstain from opioid utilization other than the study drug, and from other illicit drugs
- Male or female, 18 to 65 years of age (inclusive)
- Met clinical criteria for opioid dependence in past 12 months based on DSM-IV-TR
- Provided buprenorphine-negative urine drug screen prior to randomization
- Provided negative urine pregnancy test
- Females of childbearing potential were required to be using a reliable method of contraception (e.g., hormonal, condom with spermicide, intrauterine device \[IUD\]) after the screening visit and for the duration of the study
- Participants receiving opioids for pain must receive clearance from their prescribing physician to be withdrawn from their prescribed opioids
- Generally good health as determined by the investigator
- Participants should demonstrate at least mild withdrawal symptoms (defined as a COWS score \>9 at Day 1 predose)
You may not qualify if:
- Females who are pregnant or lactating, or planning to be pregnant during study
- Any previous prescribed treatment with buprenorphine monotherapy (e.g., generic buprenorphine sublingual tablets)
- Prescribed treatment with buprenorphine or naloxone within 90 days prior to start of treatment
- Methadone patients with any daily dose over 30 mg during the past week and who received the last dose of methadone less than 30 hours prior to start of treatment
- Participants who are unwilling or unable to comply with the requirements of the protocol
- Participants who are participating in any other clinical study in which medication(s) are being delivered or who have used an investigational drug or device within the last 30 days
- Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug
- Participants who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study
- Participants with serious untreated Axis I DSM-IV-TR psychiatric comorbidity
- Tongue piercing or other piercings in the mouth, including lips and cheek
- Participants with current or history of clinically significant medical disorder or condition
- Participants who are human immunodeficiency virus (HIV)-seropositive with a CD4+ count \<200 or active acquired immune deficiency syndrome (AIDS)
- Participants who have any Class III or IV congestive heart failure, symptomatic myocardial ischemia, a history of long QT syndrome.
- Participants who are currently taking Class 1A antiarrhythmic medications or Class III antiarrhythmic medications
- Participants who have uncontrolled hypertension or clinically significant ECG abnormalities
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orexo ABlead
- Worldwide Clinical Trialscollaborator
Study Sites (14)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Haleyville, Alabama, United States
Unknown Facility
National City, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
North Miami, Florida, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
Flowood, Mississippi, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lynn R. Webster, MD
- Organization
- PRA International
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Webster
Life Tree Pain Clinic, 3838 S 700 E Suite 200, Salt Lake City, UT 84106
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 7, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
May 10, 2017
Results First Posted
June 24, 2015
Record last verified: 2017-04