Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

Indivior

Status and phase: Completed; Phase 4

Conditions: Opioid Dependence

Treatments: Drug: Zubsolv sublingual tablets; Drug: Suboxone Sublingual Film

Study type: Interventional

Funder types: Industry

Identifiers

NCT02038790

13-131220-108 (Other Identifier)

RBP-OSZ1

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Suboxone sublingual film 8/2

Experimental group

Description:

Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.

Treatment:

Drug: Suboxone Sublingual Film

Zubsolv sublingual tablets 5.7/1.4

Active Comparator group

Description:

Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.

Treatment:

Drug: Zubsolv sublingual tablets