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Opioid-Related DisordersPhase 3NCT01848054

Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence

A Phase 3 study testing Buprenorphine/naloxone sublingual tablets and Buprenorphine in people with Opioid-Related Disorders and Opiate Dependence, run by Orexo AB at 14 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

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid-Related Disorders, Opiate Dependence
What is being tested?
Buprenorphine/naloxone sublingual tablets and Buprenorphine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
14 sitesUnited States
Study dates
Jun 2013to Jan 2014
Phase
Phase 3
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

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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
  • Participants who have a pulse oximetry ≤93% at screening, due to any medical reason.
  • Individuals with AST or ALT levels ≥3 X the upper limit of normal or total bilirubin or creatinine ≥1.5 X ULN, on the screening laboratory assessments
  • Participants with known significant liver disease.
  • Participants who take any medication, nutraceutical, herbal product with known CYP3A4 inhibition or induction properties within 14 days of screening.
  • Participants who are at suicidal risk

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Charleston, South Carolina

  • Study site

    Fall River, Massachusetts

  • Study site

    Flowood, Mississippi

  • Study site

    Haleyville, Alabama

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Maitland, Florida

  • Study site

    National City, California

  • Study site

    North Miami, Florida

  • Study site

    Oceanside, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Salt Lake City, Utah

Other trials in United States

About this study

Official title: A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence

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.

Read the detailed description

This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled, non-inferiority study conducted at 13 sites within the US. Eligible patients participated in 8 treatment visits on Days 1, 2, 3, 4, 8, 15, 22, and 29. Effectiveness of treatment was assessed as follows:

  • Retention in treatment at Day 3
  • Clinician and patient assessments of opioid withdrawal symptoms
  • Assessment opioid cravings
Being tested
Buprenorphine/naloxone sublingual tablets, Buprenorphine
Keywords
opioid dependence, buprenorphine/naloxone, sublingual
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/naloxone sublingual tabletsDrug

    Also called Zubsolv, OX219

    Advanced-formulation buprenorphine/naloxone sublingual tablets

  • BuprenorphineDrug

    Also called Generic buprenorphine

    Buprenorphine sublingual tablets

Study groups in NCT01848054
Study groupRoleWhat they receive
BNX Sublingual Tablets InductionExperimentalDay 1-2 (Blinded Induction): BNX sublingual tablets Day 3-28 (Open-label Maintenance): BNX sublingual tablets
Receives: Drug: Buprenorphine/naloxone sublingual tablets
Buprenorphine InductionActive comparatorDay 1-2 (Blinded Induction): Generic buprenorphine sublingual tablets Day 3-28 (Open-label Maintenance): BNX sublingual tablets
Receives: Drug: Buprenorphine/naloxone sublingual tablets; Drug: Buprenorphine

What is being measured

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

  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.

    Measured: Day 3

Secondary outcomes (7)

  1. Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive

    Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable

    Measured: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1

  2. AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive

    Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable

    Measured: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1

  3. AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive

    Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")

    Measured: Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1

  4. Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)

    Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable

    Measured: Predose on Days 4, 8, 15, 22, and 29

  5. Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)

    Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable

    Measured: Pre-dose on Days 4, 8, 15, 22, and 29

  6. Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)

    Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")

    Measured: Pre-dose on Days 4, 8, 15, 22, and 29

  7. Retention in Treatment in the Full Analysis Population

    Retention in treatment at Day 3 in the full analysis population (N=310) 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.

    Measured: Day 3

Timeline

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

  1. First posted7 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01848054
Sponsor's protocol ID
OX219-007
Status last verified
Apr 2017
First submitted
2 May 2013
Last updated
10 May 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Buprenorphine/naloxone sublingual tablets and Buprenorphine in people with Opioid-Related Disorders and Opiate Dependence, run by Orexo AB at 14 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 10 inclusion and 20 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 10 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 14 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?

Yes. Results are posted in the registry (first posted 24 Jun 2015). 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?

Retention in Treatment in the Per Protocol Population (time frame: Day 3). 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 NCT01848054.

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 10 May 2017.

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