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Opioid Dependence, on Agonist TherapyPhase 3ISTARTNCT01908842

Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults

A Phase 3 study testing BNX sublingual tablets, BNX sublingual film and Buprenorphine in people with Opioid Dependence, on Agonist Therapy, run by Orexo AB at 36 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 this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Dependence, on Agonist Therapy
What is being tested?
BNX sublingual tablets, BNX sublingual film and Buprenorphine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
36 sitesUnited States
Study dates
Aug 2013to Apr 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

  • Male/female 18-65 years old
  • Able to read, comprehend \& sign the informed consent form
  • Meet opioid dependence criteria in DSM-IV-TR the past 12 months
  • Have a buprenorphine-negative UDS \&/or urine dipstick
  • Prepared to abstain from opioids other than the study drug \& from other addictive drugs
  • Negative urine pregnancy test
Show all 10Show fewer
  • Females of childbearing potential who use a reliable method of contraception. Females of non-childbearing potential; surgically sterile or post-menopausal as defined by being at least 50 years of age \& having an absence of menses for at least 2 years
  • Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain
  • Lack of clinically significant abnormalities in health assessments performed at screening. Unclear cases should be approved by the medical monitor
  • At least mild withdrawal symptoms (COWS ≥9)

Who cannot join

  • Pregnant, lactating or planning to be pregnant during study
  • Unwilling/unable to comply with the requirements of the protocol (e.g., pending incarceration) are in a situation/condition that may interfere with participation in the study
  • Prescribed treatment with generic buprenorphine monotherapy within 90 days prior start of treatment
  • Daily dose of methadone over 30 mg during the past week or who received the last dose of methadone less than 30 hours prior to treatment
  • Participating in other clinical studies in which medications is delivered or who have used an investigational drug/device within the last 30 days
  • Allergy, sensitivity or intolerance to BUP, NAL or any related drug; history of drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject/study
Show all 15Show fewer
  • Staff, affiliated with, or family member of the staff directly involved with this study
  • Serious untreated Axis I DSM-IV-TR psychiatric comorbidity (actively suicidal or homicidal, have untreated schizophrenia)
  • Tongue/oral deformities that may affect the absorption of the drug products
  • Current/history of clinically significant medical disorder or condition which would jeopardize the safety or impact the validity of the results. Unclear cases should be discussed with \& approved by the medical monitor
  • HIV-seropositive with a CD4+ count <200, active AIDS defining infection in the last 120 days
  • Have Class III/IV congestive heart failure, symptomatic myocardial ischemia or history of long QT syndrome (or an immediate family member with this condition)
  • Currently taking Class 1A antiarrhythmic medications (e.g., quinidine, procainamide, \& disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, \& dofetilide)
  • Have uncontrolled hypertension, pulse oximetry ≤92%or clinically significant abnormality on 12-lead ECG, including a corrected QT (QTc) interval >450 ms
  • Severe liver disease

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Study site

    Allegheny County, Pennsylvania

  • Study site

    Baldwin County, Alabama

  • Study site

    Baltimore County, Maryland

  • Study site

    Benton County, Washington

  • Study site

    Beverly Hills, California

  • Study site

    Bristol County, Massachusetts

  • Study site

    Broward County, Florida

  • Study site

    Caddo Parish, Louisiana

  • Study site

    Camden County, New Jersey

  • Study site

    Charleston County, South Carolina

  • Study site

    Charlottesville Metropolitan Area, Virginia

  • Study site

    Chicagoland, Illinois

  • Study site

    Colombia County, Florida

  • Study site

    Dallas County, Texas

  • Study site

    DeKalb County, Georgia

  • Study site

    Delaware County, Pennsylvania

  • Study site

    Duval County, Florida

  • Study site

    Greater Metro Orlando, Florida

  • Study site

    Houston County, Alabama

  • Study site

    Johnson County, Kansas

  • Study site

    Kenton County, Kentucky

  • Study site

    Lake County, Florida

  • Study site

    Los Angeles County, California

  • Study site

    Maricopa, Arizona

  • Study site

    Miami-Dade County, Florida

  • Study site

    Oklahoma County, Oklahoma

  • Study site

    Osceola County, Florida

  • Study site

    Palm Beach County, Florida

  • Study site

    Philadelphia County, Pennsylvania

  • Study site

    Portland Metropolitan Area, Oregon

  • Study site

    Riverside County, California

  • Study site

    Saint Louis Metro Area, Missouri

  • Study site

    Salt Lake County, Utah

  • Study site

    San Diego County, California

  • Study site

    Warren County, New Jersey

  • Study site

    Warren County, Ohio

Other trials in United States

About this study

Official title: Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments

The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.

Read the detailed description

This prospective, randomized, multicenter, parallel-group, non-inferiority study was conducted at 43 centers in the United States from August 2013 to April 2014. A non-inferior design was used because both products contain the same active components, and it was considered unethical to include a placebo arm. The study comprised an induction phase of 2 days and a stabilization phase of 20 days, with study visits scheduled on Days 1, 2, 3, 4, 8, 15, and 22. Eligible opioid-dependent patients were randomly assigned within 14 days of screening to induction with either the BNX sublingual tablets or generic buprenorphine tablets for 2 days. On Day 3, patients initially allocated to buprenorphine were switched to BNX film, whereas those allocated to BNX sublingual tablets continued on the same treatment. On Day 15, patients receiving BNX film were switched to BNX sublingual tablets, and those on BNX sublingual tablets were switched to BNX film. At the final study visit on Day 22, patients were offered the option of continuing in an open-label follow-up study of BNX sublingual tablets.

Being tested
BNX sublingual tablets, BNX sublingual film, Buprenorphine
Keywords
Opioid, Dependence, agonist, buprenorphine, naloxone, BUP/NAL
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.

  • BNX sublingual tabletsDrug

    Also called OX219, Zubsolv

    Buprenorphine/naloxone sublingual tablets

  • BNX sublingual filmDrug

    Also called Suboxone film

    Buprenorphine/naloxone sublingual film

  • BuprenorphineDrug

    Also called Generic buprenorphine

    Buprenorphine sublingual tablets

Study groups in NCT01908842
Study groupRoleWhat they receive
Buprenorphine; then OL BNX film, then BNX tabletsActive comparatorDays 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: Buprenorphine/naloxone sublingual film (open-label); Days 15-21: BNX sublingual tablets (open-label); Day 22: Offered option in continuing in open-label follow-up study of BNX sublingual tablets
Receives: Drug: BNX sublingual tablets; Drug: BNX sublingual film; Drug: Buprenorphine
BNX tablets, then OL BNX tablets, then BNX filmExperimentalDays 1-2: BNX sublingual tablets (blinded); Days 3 to 14: BNX sublingual tablets (open-label); Days 15-21: Buprenorphine/naloxone sublingual film (open-label); Day 22: Offered option in continuing in open-label follow-up study of BNX sublingual tablets
Receives: Drug: BNX sublingual tablets; Drug: BNX sublingual film

What is being measured

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

  1. Primary Endpoints of Retention in Treatment at Days 3 and 15

    Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.

    Measured: Day 3 and Day 15

Secondary outcomes (6)

  1. Clinical Opiate Withdrawal Scale (COWS) Scores: Induction

    Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable

    Measured: Days 1 and 2

  2. COWS Total Scores: Stabilization/Maintenance

    Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable

    Measured: Days 3 through 22

  3. Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction

    Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable

    Measured: Days 1 and 2

  4. SOWS Total Scores: Stabilization/Maintenance

    Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable

    Measured: Days 3 through 22

  5. Visual Analog Scale (VAS) Cravings: Induction

    Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")

    Measured: Days 1 and 2

  6. VAS Craving Scores: Stabilization/Maintenance

    Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")

    Measured: Days 3 through 22

Timeline

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

  1. First posted26 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionApr 2014
  4. Study completionApr 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908842
Sponsor's protocol ID
OX219-006 Protocol Amendment 4
Acronym
ISTART
Status last verified
Apr 2017
First submitted
19 Jul 2013
Last updated
10 May 2017
Data monitoring committee
No

Publications

  • Gunderson EW, Hjelmstrom P, Sumner M; 006 Study Investigators. Effects of a higher-bioavailability buprenorphine/naloxone sublingual tablet versus buprenorphine/naloxone film for the treatment of opioid dependence during induction and stabilization: a multicenter, randomized trial. Clin Ther. 2015 Oct 1;37(10):2244-55. doi: 10.1016/j.clinthera.2015.08.025. Epub 2015 Sep 26.

    PubMed 26412801

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BNX sublingual tablets, BNX sublingual film and Buprenorphine in people with Opioid Dependence, on Agonist Therapy, run by Orexo AB at 36 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 15 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 36 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 22 May 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?

Primary Endpoints of Retention in Treatment at Days 3 and 15 (time frame: Day 3 and Day 15). 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 NCT01908842, 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 10 May 2017.

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