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

Opioid Dependence Clinical Trial

Official title:

A Single Center, Randomized, 2 Way Cross-Over, Phase 4 Study Comparing Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 Including Ease of Use, Taste Preference, Dissolution Time, Desire to Abuse, and Overall Acceptance In Buprenorphine/Naloxone Treated Opioid Dependent Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02038790
• Other study ID #: RBP-OSZ1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 15, 2014
• Last updated: January 15, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2013
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Suboxone Sublingual Film
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.
• Zubsolv sublingual tablets
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.

Locations

Country	Name	City	State
United States	Hill Top Research	St Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Intervention Preference As Recorded by Participants		Day 0 (post treatment), Day 1	No
Secondary	Taste preference including taste acceptability as Assessed by Participants		Days 0-1	No
Secondary	Participant Desire to abuse as Assessed by Participants		Days 0-1	No
Secondary	Dissolution time of Intervention as Recorded by a Trained Observer		Days 0-1	No
Secondary	Overall acceptability of Intervention as Assessed by Participants	An overall assessment of administration, portability, and packaging of the two test articles	Days 0-1	No
Secondary	Ease-of-use As Assessed by Participants		Days 0-1	No
Secondary	Change from Baseline in Subject Opiate Withdrawal Scale (SOWS)		Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)	No