BuprenorphineOPUS RNCT00723697

Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)

An observational study of Buprenorphine and Naloxone, run by Indivior Inc..

Completed

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

Trial summary

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Read more about this study

Who is it for?: Any age
Conditions the study is for: Buprenorphine, Naloxone, Opiate-related Disorders
What is being tested?: buprenorphine
Type of treatment: Pill or oral medicine
How many people: 1,307 participants
Where: No sites listed yet
Study dates: May 2007to Feb 2010
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)

Who may be able to join

Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician.
The patient must have been informed orally and in writing via the information notice and have signed it.

Who cannot join

Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic

About this study

Official title: Etude Observationnelle Prospective de l'Utilisation en Situation Reelle; Prospective Real Situation Observational Study of Subutex® or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters With Respect to Misuse and Pharmacovigilance

Read the detailed description

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.

Conditions: Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence, Drug Abuse
Being tested: buprenorphine
Keywords: Subutex
Medical subject headings: Opioid-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

buprenorphineDrug
Also called Subutex, buprenorphine high dose (BHD) generic (Arrow Laboratories), SCH 028444
0.4, 2, or 8 mg sublingual tablets

Study groups in NCT00723697
Study group	Role	What they receive
Patients		Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice. Receives: Drug: buprenorphine

What is being measured

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

Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)
Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Measured: first visit, 6 months, and 12 months
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.
Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Measured: first visit, 6 months, and 12 months

Secondary outcomes (1)

Number of Patients Reporting Clinical Consequences of Engaging in Misuse
Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.
Measured: first visit, 6 months, and 12 months

Timeline

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

May 2007Feb 2010

First posted29 Jul 2008 (estimated)
Study startMay 2007
Primary completionFeb 2010
Study completionFeb 2010

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 BuprenorphineStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00723697
Sponsor's protocol ID: P05186
Acronym: OPUS R
Status last verified: Mar 2023
First submitted: 25 Jul 2008
Last updated: 20 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

RecruitingPhase 1/2
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
Opioid Withdrawal, Chronic Pain
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 2
A Study of Brenipatide in Participants With Opioid Use Disorder
Opioid Use Disorder
Not yet recruiting
Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)
Opioid Use Disorder
Not yet recruitingPhase 4
Examining Analgesic Synergy and Efficacy in Trauma Care
Opioid Use Disorder

All Buprenorphine trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Etude Observationnelle Prospective de l'Utilisation en Situation Reelle; Prospective Real Situation Observational Study of Subutex® or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters With Respect to Misuse and Pharmacovigilance
ClinicalTrials.gov ID: NCT00723697
Acronym / sponsor ID: OPUS R / P05186
Conditions: Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence, Drug Abuse
Keywords: Subutex
Study type: Observational
Recruitment status: Completed
Enrolment: 1,307 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 29 Jul 2008 (estimated)
Results: Posted 10 May 2011

Clinical summary

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

Detailed description

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients	–	Drug: buprenorphinePatients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)

Key inclusion criteria (2 listed)

Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician.
The patient must have been informed orally and in writing via the information notice and have signed it.

Key exclusion criteria (1 listed)

Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic

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
buprenorphineAlso: Subutex, buprenorphine high dose (BHD) generic (Arrow Laboratories), SCH 0284440.4, 2, or 8 mg sublingual tablets	Drug	Patients

Primary outcome

Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)
Time frame: first visit, 6 months, and 12 months
Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.
Time frame: first visit, 6 months, and 12 months
Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

1 secondary outcome

Number of Patients Reporting Clinical Consequences of Engaging in Misuse
Time frame: first visit, 6 months, and 12 months

Results and safety

Results posted to the registry on 10 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients	1,307	1,289

Primary outcome: Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)

Time frame: first visit, 6 months, and 12 months. Number. Unit: participants

Measure	Patients n = 880
Proper usage at all visits (no misuse)	131 (30.61 to 39.57)
Misuse at M12 only	20
Misuse at M6 only	15
Misuse at D1 only	38
Misuse at M6 and M12 only	19
Misuse at D1 and M12 only	24
Misuse at D1 and M6 only	34
Misuse at all visits	151

Population analysed: Number of patients with self-questionnaire responses.

Primary outcome: Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.

Time frame: first visit, 6 months, and 12 months. Number. Unit: participants

Measure	Patients n = 1289
Proper usage at all visits (no misuse)	206
Misuse at M12 only	37
Misuse at M6 only	37
Misuse at D1 only	134
Misuse at M6 and M12 only	52
Misuse at D1 and M12 only	49
Misuse at D1 and M6 only	72
Misuse at all visits	407

Population analysed: All eligible patients

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients	34 of 1,305 (2.6%)	0 of 1,305 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Buprenorphine

RecruitingPhase 1/2
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
Opioid Withdrawal, Chronic Pain
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 2
A Study of Brenipatide in Participants With Opioid Use Disorder
Opioid Use Disorder
Not yet recruiting
Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)
Opioid Use Disorder
Not yet recruitingPhase 4
Examining Analgesic Synergy and Efficacy in Trauma Care
Opioid Use Disorder

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Buprenorphine and Naloxone, run by Indivior Inc..

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 2 inclusion and 1 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2011). 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?

Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) (time frame: first visit, 6 months, and 12 months). The study lists 2 primary outcomes in all. 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 NCT00723697.

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 Mar 2023.