Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
Condition: Opioid-Related Disorders; Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine/naloxone sublingual tablets; Buprenorphine
Intervention description: Advanced-formulation buprenorphine/naloxone sublingual tablets; Buprenorphine sublingual tablets
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opioid dependence, buprenorphine/naloxone, sublingual

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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             physician to be withdrawn from their prescribed opioids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)

        Exclusion Criteria:

          -  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

          -  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