Opioid Related DisorderPhase 2NCT01582347

Transfer of Subjects From Subutex/Suboxone to RBP-6300

A Phase 2 study testing RBP-6300 and Subutex®/Suboxone® in people with Opioid Related Disorder, run by Indivior Inc. at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Opioid Related Disorder
What is being tested?: RBP-6300 and Subutex®/Suboxone®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 143 participants
Where: 15 sitesin 4 countries
Study dates: Mar 2012to Nov 2012
Phase: Phase 2
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be Male or non-pregnant, non-lactating females
Be at least 18 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual-IV-TEXT REVISION)criteria for opioid dependence at screening
Be on stable dose of 8, 16, or 24mg/day for about 30 days prior to screening
Female subjects of childbearing potential must have a negative urine test prior to enrollment into the study

Who cannot join

Have participated in an experimental drug or device study within the last 60 days
If female, be breast feeding or lactating
Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study
Have a clinically significant abnormal finding (in the opinion of the investigator)

Trial locations and contacts

15 sites in 4 countries.

Country

City, postcode or hospital

15 sites in 4 countries

Germany7 sites

Dr. Tietje
Bremen, 28719
Prof. Scherbaum
Essen, 45147
Dr. Weber
Kassel, 34117
PD. Dr. Pogarell
Munich, 80336
Dr. Rechenmacher
Oldenburg, 26121
Dr. Boniakowski
Regensburg, 93051
Dr. Issler
Stuttgart, 70197

Other trials in Germany

Austria4 sites

Prof. Dr. Fleischhacker
Austria, 6020
Dr. Lindenbauer
Linz, 4020
Prof. Dr. Wurst
Salzburg, 5020
Prof. Wolzt
Vienna, 1090

Other trials in Austria

Czechia2 sites

Dr. Vehak
Prague, 1400
Dr. Stankova
Ústí nad Labem, 40113

Other trials in Czechia

Sweden2 sites

Dr. Kilaidakis
Örebro, 70185
Dr. Georgieva
Stockholm, 17176

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Double-dummy, Active-drug-controlled, Parallel-group, Multicentre Acceptability and Safety Study of the Transfer From Subutex/Suboxone to RBP-6300 in Opioid-dependent Subjects

Read the detailed description

During the open-label Run-In Period (study days -7 to -1), participants receive Subutex®/Suboxone® at one of three dose levels, depending on the dose level for that subject on entry to the study: 8 mg/day, 16 mg/day, or 24 mg/day.

During the 7-day, active drug-controlled, double-blind Transfer Period (study days 1-7), participants are randomized to either Subutex®/Suboxone® or RBP-6300 active drug at dosing levels equivalent to the level during the Run-In Period plus placebo matching the other drug.

This is followed by a 3-day single-blind Subutex®/Suboxone® Transition Period in which participants receive the same dose given during the Run-In Period.

Conditions: Opioid Related Disorder
Being tested: RBP-6300, Subutex®/Suboxone®, Placebo for RBP-6300, Placebo for Subutex®/Suboxone®
Keywords: Opioid dependence
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.

RBP-6300Drug
Also called buprenorphine hemiadipate HCl, naloxone HCl
Participants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7).
Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate.
Subutex®/Suboxone®Drug
Also called buprenorphine, naloxone
Participants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods.
Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods.
Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone.
Placebo for RBP-6300Drug
Also called placebo
Participants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods.
Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period.
Placebo for Subutex®/Suboxone®Drug
Also called placebo
Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.

Study groups in NCT01582347
Study group	Role	What they receive
RBP-6300	Experimental	During the Double-Blind Transfer Period (Days 1-7), participants take RBP-6300 at a level (either 10, 20 or 30 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for Subutex®/Suboxone®. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000. Receives: Drug: RBP-6300; Drug: Subutex®/Suboxone®; Drug: Placebo for RBP-6300; Drug: Placebo for Subutex®/Suboxone®
Subutex®/Suboxone®	Active comparator	During the Double-Blind Transfer Period (Days 1-7), participants take Subutex®/Suboxone® at a level (either 8, 16 or 240 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for RBP-6000. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000. Receives: Drug: Subutex®/Suboxone®; Drug: Placebo for RBP-6300

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment
To demonstrate that RBP-6300 is not inferior to Subutex/Suboxone as assessed by the peak change from baseline in the pre-dose COWS score during the double-blind transfer phase
Measured: 7 days

Secondary outcomes (1)

Assess the overall clinical response to RBP-6300
One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Nov 2012

First posted20 Apr 2012 (estimated)
Study startMar 2012
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Opioid Related DisorderStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01582347
Sponsor's protocol ID: RB-UK-11-0017
Status last verified: Jan 2017
First submitted: 18 Apr 2012
Last updated: 20 Jan 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Related Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double-dummy, Active-drug-controlled, Parallel-group, Multicentre Acceptability and Safety Study of the Transfer From Subutex/Suboxone to RBP-6300 in Opioid-dependent Subjects
ClinicalTrials.gov ID: NCT01582347
Acronym / sponsor ID: RB-UK-11-0017
Conditions: Opioid Related Disorder
Keywords: Opioid dependence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 20 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is followed by a 3-day single-blind Subutex®/Suboxone® Transition Period in which participants receive the same dose given during the Run-In Period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
RBP-6300	Experimental	Drug: RBP-6300, Drug: Subutex®/Suboxone®, Drug: Placebo for RBP-6300, Drug: Placebo for Subutex®/Suboxone®During the Double-Blind Transfer Period (Days 1-7), participants take RBP-6300 at a level (either 10, 20 or 30 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for Subutex®/Suboxone®. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000.
Subutex®/Suboxone®	Active comparator	Drug: Subutex®/Suboxone®, Drug: Placebo for RBP-6300During the Double-Blind Transfer Period (Days 1-7), participants take Subutex®/Suboxone® at a level (either 8, 16 or 240 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for RBP-6000. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Be Male or non-pregnant, non-lactating females
Be at least 18 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual-IV-TEXT REVISION)criteria for opioid dependence at screening
Be on stable dose of 8, 16, or 24mg/day for about 30 days prior to screening
Female subjects of childbearing potential must have a negative urine test prior to enrollment into the study

Key exclusion criteria (4 listed)

Have participated in an experimental drug or device study within the last 60 days
If female, be breast feeding or lactating
Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study
Have a clinically significant abnormal finding (in the opinion of the investigator)

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
RBP-6300Also: buprenorphine hemiadipate HCl, naloxone HClParticipants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7). Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate.	Drug	RBP-6300
Subutex®/Suboxone®Also: buprenorphine, naloxoneParticipants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods. Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods. Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone.	Drug	RBP-6300, Subutex®/Suboxone®
Placebo for RBP-6300Also: placeboParticipants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods. Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period.	Drug	RBP-6300, Subutex®/Suboxone®
Placebo for Subutex®/Suboxone®Also: placeboParticipants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.	Drug	RBP-6300

Primary outcome

Treatment
Time frame: 7 days
To demonstrate that RBP-6300 is not inferior to Subutex/Suboxone as assessed by the peak change from baseline in the pre-dose COWS score during the double-blind transfer phase

1 secondary outcome

Assess the overall clinical response to RBP-6300
Time frame: one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.

Related trials for Opioid Related Disorder

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
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Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe

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.

Norbert Scherbaum, Prof. Dr. principal investigator

Medical University, Duisburg-Essen, Germany

Michael Wolzt, Prof. Dr. principal investigator

Univ.-Klinik fur Klinische Pharmakologie, AKH Wien, Wien

Wolfgang Fleischhacker, Prof. Dr. principal investigator

Medical University Innsbruck

15 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RBP-6300 and Subutex®/Suboxone® in people with Opioid Related Disorder, run by Indivior Inc. at 15 sites in 4 countries.

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 5 inclusion and 4 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, Austria, Czechia, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01582347.

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 20 Jan 2017.