Clinical trial NCT02038790: Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Dependence
Keywords: opioid dependence
buprenorphine/naloxone
Opioid-Related Disorders
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Intervention Preference As Assessed by Participants
timeFrame: Day 1
Secondary outcomes:
measure: Participant Preference With Regard to Overall Taste of Interventions
timeFrame: Day 1
measure: Participant Assessments With Regard to Ease of Dissolution of Interventions
timeFrame: Day 1
measure: Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
timeFrame: Days 0-1
measure: Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
timeFrame: Days 0-1
measure: Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
timeFrame: Days 0-1
measure: Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
timeFrame: Days 0-1
measure: Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
timeFrame: Days 0-1
measure: Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
timeFrame: Days 0-1
measure: Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
timeFrame: Days 0-1
measure: Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
timeFrame: Days 0-1
measure: Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
timeFrame: Days 0-1
measure: Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
timeFrame: Days 0-1
measure: Dissolution Time of Intervention as Recorded by a Trained Observer
timeFrame: Days 0-1
measure: Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)
timeFrame: Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)
Other outcomes:
Locations:
city: St Petersburg
country: United States
facility: Hill Top Research
state: Florida
Study officials:
affiliation: Hill Top Research
name: John Murray, MD
role: PRINCIPAL_INVESTIGATOR
References: