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Opioid Dependence, on Agonist TherapyPhase 4NCT01903005

Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

A Phase 4 study testing Higher bioavailability BNX sublingual tablets in people with Opioid Dependence, on Agonist Therapy, run by Orexo AB at 28 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 safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219. 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?
Higher bioavailability BNX sublingual tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
668 participants
Where
28 sitesUnited States
Study dates
Jul 2013to Sep 2014
Phase
Phase 4
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

  • Signed informed consent form.
  • Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets (OX219-006 or OX219-007).
  • Female patients of child bearing potential who used a reliable method of contraception (hormonal, condom with spermicide, intrauterine device) during the previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study. Females who are not of child-bearing potential who are either surgically sterile (by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or postmenopausal, as defined by being at least 50 years of age and having had an absence of menses for at least 2 years, were also eligible.

Who cannot join

  • Females who are pregnant (positive pregnancy test result) or lactating, or planning to become pregnant during the study.
  • Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
  • Participants who are participating in any other clinical study in which medication(s) are being delivered or who had 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, or history of any drug hypersensitivity or intolerance that, in the opinion of the investigator, would compromise the safety of the subject or the study.
  • Participant with a contra-indicated serious medical condition.
  • Participants who are at suicidal risk as determined by any of the following: a history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale (C-SSRS).

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Study site

    Baltimore County, Maryland

  • Study site

    Benton County, Washington

  • Study site

    Bristol County, Massachusetts

  • Study site

    Broward County, Florida

  • Study site

    Charleston County, South Carolina

  • Study site

    Chicago Metropolitan Area, Illinois

  • Study site

    Columbia County, Florida

  • Study site

    DeKalb County, Georgia

  • Study site

    Delaware County, Pennsylvania

  • Study site

    Duval County, Florida

  • Study site

    Jacksonville Metropolitan Area, Florida

  • Study site

    Jefferson County, Alabama

  • Study site

    Los Angeles County, California

  • Study site

    Maricopa County, Arizona

  • Study site

    Marion County, Alabama

  • Study site

    Miami-Dade County, Florida

  • Study site

    Oklahoma County, Oklahoma

  • Study site

    Orlando Metropolitan Area, Florida

  • Study site

    Osceola County, Florida

  • Study site

    Palm Beach County, Florida

  • Study site

    Philadelphia County, Pennsylvania

  • Study site

    Portland Metropolitan Area, Oregon

  • Study site

    Rankin County, Mississippi

  • Study site

    Saint Louis Metropolitan Area, Missouri

  • Study site

    Salt Lake County, Utah

  • Study site

    San Diego County, California

  • Study site

    Warren County, New Jersey

  • Study site

    Winston County, Alabama

Other trials in United States

About this study

Official title: A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Read the detailed description

This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 [NCT01908842] or OX219-007 [NCT01848054]). The total duration of study treatment was 24 weeks.

Being tested
Higher bioavailability BNX sublingual tablets
Keywords
Opioid, Dependence, agonist, Buprenorphine, Naloxone
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.

  • Higher bioavailability BNX sublingual tabletsDrug

    Also called OX219, Zubsolv, Buprenorphine/naloxone sublingual tablets

    Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Study groups in NCT01903005
Study groupRoleWhat they receive
Open-label BNX sublingual tabletsExperimentalWeeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Receives: Drug: Higher bioavailability BNX sublingual tablets

What is being measured

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

  1. Number of Patients Reporting Treatment-Emergent Adverse Events

    Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets

    Measured: Day 1 through week 24

  2. Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events

    Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets

    Measured: Day 1 through week 24

  3. Number of Patients Reporting Treatment-Emergent Serious Adverse Events

    Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets

    Measured: Day 1 throught week 24

  4. Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events

    Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets

    Measured: Day 1 through week 24

Secondary outcomes (7)

  1. Retention in Treatment in the Safety Population

    Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)

    Measured: Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24

  2. Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score

    Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS

    Measured: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint

  3. Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score

    Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS

    Measured: Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint

  4. Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores

    Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving

    Measured: Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint

  5. Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)

    Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end

    Measured: Study Endpoint

  6. Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP

    Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?

    Measured: Week 24

  7. Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP

    Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)

    Measured: Week 24

Timeline

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

  1. First posted19 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2014
  4. Study completionSep 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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
668 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903005
Sponsor's protocol ID
OX219-008
Status last verified
Sep 2015
First submitted
9 Jul 2013
Last updated
28 Oct 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Higher bioavailability BNX sublingual tablets in people with Opioid Dependence, on Agonist Therapy, run by Orexo AB at 28 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 3 inclusion and 6 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 28 Oct 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?

Number of Patients Reporting Treatment-Emergent Adverse Events (time frame: Day 1 through week 24). The study lists 4 primary outcomes in all. 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 NCT01903005.

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 28 Oct 2015.

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