Opioid DependencePhase 4NCT02038790
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
A Phase 4 study testing Suboxone Sublingual Film and Zubsolv sublingual tablets in people with Opioid Dependence, run by Indivior Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Suboxone Sublingual Film and Zubsolv sublingual tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Suboxone Sublingual Film, Zubsolv sublingual tablets
- Keywords
- opioid dependence, buprenorphine/naloxone, Opioid-Related Disorders
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboxone Sublingual FilmDrug
Also called buprenorphine, naloxone
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 tabletsDrug
Also called buprenorphine, naloxone
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Zubsolv sublingual tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Day 1
Secondary outcomes (14)
Participant Preference With Regard to Overall Taste of Interventions
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: Which one did you prefer in regards to overall taste?
Measured: Day 1
Participant Assessments With Regard to Ease of Dissolution of Interventions
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: Which one did you think dissolve easier in your mouth?
Measured: Day 1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Measured: Days 0-1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Measured: Days 0-1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Measured: Days 0-1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Measured: Days 0-1
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Measured: Days 0-1
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Measured: Days 0-1
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'
Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.
Measured: Days 0-1
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
Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.
Measured: Days 0-1
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Choices to the question above are:
- Crush and snort
- Liquefy and inject
- Not able to abuse this formulation
Measured: Days 0-1
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.....
Choices to the question above are:
- More effective as a treatment for opioid dependence
- Equally effective as a treatment for opioid dependence
- Less effective as a treatment for opioid dependence
- The same medication that I normally use
Measured: Days 0-1
Dissolution Time of Intervention as Recorded by a Trained Observer
The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.
Measured: Days 0-1
Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)
Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment.
SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format.
Measured: Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Murray, MD, Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038790
- Sponsor's protocol ID
- RBP-OSZ1
- Other IDs
- 13-131220-108
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2014
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02038790
- Acronym / sponsor ID
- RBP-OSZ1
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, buprenorphine/naloxone, Opioid-Related Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 21 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboxone sublingual film 8/2 | Experimental | Drug: Suboxone Sublingual FilmParticipants 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. |
| Zubsolv sublingual tablets 5.7/1.4 | Active comparator | Drug: Zubsolv sublingual tabletsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suboxone Sublingual FilmAlso: buprenorphine, naloxoneA 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. | Drug | Suboxone sublingual film 8/2 |
| Zubsolv sublingual tabletsAlso: buprenorphine, naloxoneA 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. | Drug | Zubsolv sublingual tablets 5.7/1.4 |
Primary outcome
Overall Intervention Preference As Assessed by Participants
Time frame: Day 1
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?
14 secondary outcomes
Participant Preference With Regard to Overall Taste of Interventions
Time frame: Day 1
Participant Assessments With Regard to Ease of Dissolution of Interventions
Time frame: Day 1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Time frame: Days 0-1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Time frame: Days 0-1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Time frame: Days 0-1
Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Time frame: Days 0-1
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
Time frame: Days 0-1
Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
Time frame: Days 0-1
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'
Time frame: Days 0-1
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
Time frame: Days 0-1
Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Time frame: Days 0-1
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.....
Time frame: Days 0-1
Dissolution Time of Intervention as Recorded by a Trained Observer
Time frame: Days 0-1
Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)
Time frame: Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Murray, MD principal investigator
Hill Top Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suboxone Sublingual Film and Zubsolv sublingual tablets in people with Opioid Dependence, run by Indivior Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Intervention Preference As Assessed by Participants (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.