Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Suboxone Sublingual Film; Zubsolv sublingual tablets
Intervention description: A single Suboxone sublingual film strip containing 8mg buprenorphine and 2mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.; A single Zubsolv sublingual tablet containing 5.7mg buprenorphine and 1.4mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid dependence; buprenorphine/naloxone; Opioid-Related Disorders

Summary:

      The primary objective of this study is to compare overall patient preference for either
      Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual
      film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7
      mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs
      like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of
      time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  currently on a single daily dose of 8/2 of Suboxone or generic equivalent, or 5.7/1.4
             mg Zubsolv for treatment of opioid dependence that has been medically confirmed.

          -  in good general health with no specific contraindication for treatment with
             buprenorphine or naloxone.

          -  the ability to understand, sign and date written consent and Health Information
             Portability and Accountability Act (HIPAA) authorization forms, which must be obtained
             prior to any study related procedures being completed.

          -  Female subjects must be postmenopausal for at least 2 years, surgically sterile (i.e.
             tubal ligation, hysterectomy, or bilateral ovariectomy), or practicing an effective
             method of contraception during the study with one of the following methods: oral
             contraception, intrauterine device (IUD), abstinence, contraceptive injections,
             conscientious use of a diaphragm or condoms and spermicidal foam, systemic (implant)
             contraception or partner has had a vasectomy.

        Exclusion Criteria:

          -  Subject is taking other opioids (other than buprenorphine/naloxone) that may interfere
             with the study evaluations or compromise the safety of the subject.

          -  Subject is not able to read or have other impairments that may prevent completion of
             questionnaires or other study evaluations

          -  Subject has open sores present in the oral cavity.

          -  Subject has participated in any previous clinical testing involving investigational
             drug within the 4 weeks prior to study start.

          -  Subject is pregnant, lactating or planning a pregnancy

          -  Subject is currently participating in any other type of clinical testing.

          -  Subject has a medical condition that in the Investigator's opinion could affect the
             taste assessments required by the study

          -  Subject is judged by the Investigator after reviewing medical history to be unsuitable
             for any other reason that may either place the subject at increased risk during
             participation or interfere with the interpretation of the study outcomes.