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

NCT02038790 | Completed Phase 4 Results

• 2 other identifiers: RBP-OSZ113-131220-108
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Dependence

Keywords

opioid dependence; buprenorphine/naloxone; Opioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Overall Intervention Preference As Assessed by Participants

  At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?

  Day 1

Secondary Outcomes (14)

• Participant Preference With Regard to Overall Taste of Interventions

  Day 1

• Participant Assessments With Regard to Ease of Dissolution of Interventions

  Day 1

• Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?

  Days 0-1

• Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?

  Days 0-1

• Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?

  Days 0-1

Study Arms (2)

Suboxone sublingual film 8/2

EXPERIMENTAL

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.

Drug: Suboxone Sublingual Film

Zubsolv sublingual tablets 5.7/1.4

ACTIVE COMPARATOR

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.

Drug: Zubsolv sublingual tablets

Interventions

Suboxone Sublingual Film DRUG

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.

Also known as: buprenorphine, naloxone

Suboxone sublingual film 8/2

Zubsolv sublingual tablets DRUG

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.

Also known as: buprenorphine, naloxone

Zubsolv sublingual tablets 5.7/1.4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

Hill Top Research

St. Petersburg, Florida, 33714, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Naloxone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Global Director Clinical Development
• Organization: Indivior, Inc.

804-379-1090

Study Officials

• John Murray, MD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 21, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-01

Locations

US (1)