Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
Condition: Opioid Dependence, on Agonist Therapy
MeSH terms: Opioid-Related Disorders
Intervention: Higher bioavailability BNX sublingual tablets
Intervention description: Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 668.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid, Dependence, agonist, Buprenorphine, Naloxone

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.
    

Eligibility criteria:

        Inclusion criteria

          -  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.

        Exclusion criteria

          -  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).