Opioid DependencyPhase 4RIMENCT00955162
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
A Phase 4 study testing Buprenorphine (Subutex) and Buprenorphine/naloxone (Suboxone) in people with Opioid Dependency, run by Indivior Inc. at 20 sites in France.
Trial summary
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependency
- What is being tested?
- Buprenorphine (Subutex) and Buprenorphine/naloxone (Suboxone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 20 sitesFrance
- Study dates
- Aug 2009to May 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female opioid-dependent outpatient aged 18 years or older,
- Women of childbearing potential must have a negative urine pregnancy test result at the Inclusion Visit (test under supervision of the investigator or designee),
- Women of childbearing potential must use an effective birth control method. Women of non-childbearing potential must be postmenopausal or must be surgically sterile (hysterectomy and/or bilateral oophorectomy),
- On buprenorphine (Subutex® or generic buprenorphine) maintenance therapy at a minimum daily dose of 2 mg for at least 3 months prior to inclusion,
- Declaring buprenorphine intravenous misuse at least four times/week and showing needle marks,
- Willing to stop or reduce buprenorphine intravenous misuse,
- Having received oral and written information about the trial, and provided written informed consent prior to admission to this trial.
Who cannot join
- Pregnancy or breast-feeding,
- Contraindication or history of hypersensitivity to buprenorphine, naloxone or to any excipient of Suboxone® or Subutex®,
- Any medical or psychiatric condition which in the opinion of the investigator would make participation difficult or unsafe,
- Participating in another trial,
- Patients in the exclusion period of the "Fichier National des personnes qui se prêtent à des recherches biomédicales" (National Index of persons participating in biomedical researches, or National Index of volunteers).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Csst Antibes
Antibes
Hopital Paul Guiraud
Bagneux
Cssa Bizia
Bayonne
Centre Carreire , CH Charles Perrens
Bordeaux
CHU de Clermont-Ferrand, Centre Méthadone
Clermont-Ferrand
Service d'addictologie, Hopital de Dole
Dole
CSST NAUTILIA (Ex Alinea)
Le Havre
CSST Le Cèdre Bleu
Lille
Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie
Limoges
Centre Baudelaire
Metz
Csst de Montauban
Montauban
CSST Centre Hospitalier
Nice
CSST Logos
Nîmes
Hôpital Caremeau
Nîmes
Csst Espace Murger
Paris
Hôpital Saint Anne
Paris
Centre L'Envol (Csst)
Rennes
Centre Baudelaire
Thionville
Hopital Joseph Ducuing
Toulouse
CSST Centre Port Bretagne CH Charles Perrens
Tours
About this study
Official title: A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries.
Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.
Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.
- Conditions
- Opioid Dependency
- Being tested
- Buprenorphine (Subutex), Buprenorphine/naloxone (Suboxone)
- Keywords
- Substance Abuse, Intravenous, Buprenorphine
- Medical subject headings
- Substance Abuse, Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine (Subutex)Drug
Also called Subutex
Sublingual tablet
Buprenorphine/naloxone (Suboxone)Drug
Also called Suboxone
Sublingual tablet
| Study group | Role | What they receive |
|---|---|---|
| Subutex | Active comparator | Not described Receives: Drug: Buprenorphine (Subutex) |
| Suboxone | Experimental | Not described Receives: Drug: Buprenorphine/naloxone (Suboxone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of study drug injections per week
Measured: 1 week
Secondary outcomes (2)
Addiction severity
Measured: 3 months
Withdrawal severity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependencyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier TOUZEAU, MD, Principal investigator, Hôpital Paul Guiraud, Bagneux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955162
- Sponsor's protocol ID
- BU0902
- Acronym
- RIME
- Status last verified
- Jan 2010
- First submitted
- 5 Aug 2009
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Open-label, Active-controlled Trial of the Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France
- ClinicalTrials.gov ID
- NCT00955162
- Acronym / sponsor ID
- RIME / BU0902
- Conditions
- Opioid Dependency
- Keywords
- Substance Abuse, Intravenous, Buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Aug 2009 (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.
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries.
Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.
Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subutex | Active comparator | Drug: Buprenorphine (Subutex) |
| Suboxone | Experimental | Drug: Buprenorphine/naloxone (Suboxone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female opioid-dependent outpatient aged 18 years or older,
- Women of childbearing potential must have a negative urine pregnancy test result at the Inclusion Visit (test under supervision of the investigator or designee),
- Women of childbearing potential must use an effective birth control method. Women of non-childbearing potential must be postmenopausal or must be surgically sterile (hysterectomy and/or bilateral oophorectomy),
- On buprenorphine (Subutex® or generic buprenorphine) maintenance therapy at a minimum daily dose of 2 mg for at least 3 months prior to inclusion,
- Declaring buprenorphine intravenous misuse at least four times/week and showing needle marks,
Key exclusion criteria (5 listed)
- Pregnancy or breast-feeding,
- Contraindication or history of hypersensitivity to buprenorphine, naloxone or to any excipient of Suboxone® or Subutex®,
- Any medical or psychiatric condition which in the opinion of the investigator would make participation difficult or unsafe,
- Participating in another trial,
- Patients in the exclusion period of the "Fichier National des personnes qui se prêtent à des recherches biomédicales" (National Index of persons participating in biomedical researches, or National Index of volunteers).
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 |
|---|---|---|
| Buprenorphine (Subutex)Also: SubutexSublingual tablet | Drug | Subutex |
| Buprenorphine/naloxone (Suboxone)Also: SuboxoneSublingual tablet | Drug | Suboxone |
Primary outcome
number of study drug injections per week
Time frame: 1 week
2 secondary outcomes
Addiction severity
Time frame: 3 months
Withdrawal severity
Time frame: 1 month
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 30 Nov 2012.
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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.
Didier TOUZEAU, MD principal investigator
Hôpital Paul Guiraud, Bagneux
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine (Subutex) and Buprenorphine/naloxone (Suboxone) in people with Opioid Dependency, run by Indivior Inc. at 20 sites in France.
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 7 inclusion and 5 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 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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?
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?
number of study drug injections per week (time frame: 1 week). 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 30 Nov 2012.