Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Condition: Opioid Dependence, on Agonist Therapy
MeSH terms: Opioid-Related Disorders
Intervention: BNX sublingual tablets; BNX sublingual film; Buprenorphine
Intervention description: Buprenorphine/naloxone sublingual tablets; Buprenorphine/naloxone sublingual film; Buprenorphine sublingual tablets
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 759.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid; Dependence; agonist; buprenorphine; naloxone; BUP/NAL

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. Secondary objectives
      included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and
      safety.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male/female 18-65 years old

          2. Able to read, comprehend & sign the informed consent form

          3. Meet opioid dependence criteria in DSM-IV-TR the past 12 months

          4. Have a buprenorphine-negative UDS &/or urine dipstick

          5. Prepared to abstain from opioids other than the study drug & from other addictive
             drugs

          6. Negative urine pregnancy test

          7. 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

          8. Clearance from the prescribing MD to be withdrawn from their prescribed opioids for
             subjects receiving opioids for pain

          9. Lack of clinically significant abnormalities in health assessments performed at
             screening. Unclear cases should be approved by the medical monitor

         10. At least mild withdrawal symptoms (COWS ≥9)

        Exclusion Criteria:

          1. Pregnant, lactating or planning to be pregnant during study

          2. 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

          3. Prescribed treatment with generic buprenorphine monotherapy within 90 days prior start
             of treatment

          4. 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

          5. Participating in other clinical studies in which medications is delivered or who have
             used an investigational drug/device within the last 30 days

          6. 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

          7. Staff, affiliated with, or family member of the staff directly involved with this
             study

          8. Serious untreated Axis I DSM-IV-TR psychiatric comorbidity (actively suicidal or
             homicidal, have untreated schizophrenia)

          9. Tongue/oral deformities that may affect the absorption of the drug products

         10. 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

         11. HIV-seropositive with a CD4+ count <200, active AIDS defining infection in the last
             120 days

         12. Have Class III/IV congestive heart failure, symptomatic myocardial ischemia or history
             of long QT syndrome (or an immediate family member with this condition)

         13. Currently taking Class 1A antiarrhythmic medications (e.g., quinidine, procainamide, &
             disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, &
             dofetilide)

         14. Have uncontrolled hypertension, pulse oximetry ≤92%or clinically significant
             abnormality on 12-lead ECG, including a corrected QT (QTc) interval >450 ms

         15. Severe liver disease