Opioid-Related DisordersNCT00723749

Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

An observational study of Opioid-Related Disorders and Opiate Dependence, 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 aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Opioid-Related Disorders, Opiate Dependence, Drug Abuse
What is being tested?: Buprenorphine/Naloxone
Type of treatment: Pill or oral medicine
How many people: 384 participants
Where: No sites listed yet
Study dates: Mar 2008to Dec 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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Opioid-dependent patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Who may be able to join

Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Who cannot join

In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

About this study

Official title: Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.

Read the detailed description

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

Conditions: Opioid-Related Disorders, Opiate Dependence, Drug Abuse
Being tested: Buprenorphine/Naloxone
Keywords: Suboxone, Subutex, Buprenorphine, Naloxone
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.

Buprenorphine/NaloxoneDrug
Also called SCH 000484, SUBOXONE®
Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine \& 0.5 mg naloxone and 8 mg buprenorphine \& 2 mg naloxone.
The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.

Study groups in NCT00723749
Study group	Role	What they receive
Suboxone		Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months. Receives: Drug: Buprenorphine/Naloxone

What is being measured

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

Retention Rate After 12 Months of Treatment With Suboxone
The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.
Measured: 12 months

Secondary outcomes (3)

Dosage of SUBOXONE®
Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.
Measured: Day 1 and Final Assessment (month 12 or time of dropout)
Take Home Prescriptions of SUBOXONE®
Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.
Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.
A patient can receive only one take home prescription for up to 7 days at the time.
Measured: Day 1 and Final Assessment (month 12 or time of dropout)
Drug Craving (Subjective Effects of Therapy)
Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)
Measured: Baseline and Final Assessment (month 12 or time of dropout)

Timeline

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

Mar 2008Dec 2010

First posted29 Jul 2008 (estimated)
Study startMar 2008
Primary completionDec 2010
Study completionDec 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 Opioid-Related DisordersStudies 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: 384 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00723749
Sponsor's protocol ID: P05603
Status last verified: Apr 2012
First submitted: 25 Jul 2008
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
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?

Official record

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All Opioid-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.
ClinicalTrials.gov ID: NCT00723749
Acronym / sponsor ID: P05603
Conditions: Opioid-Related Disorders, Opiate Dependence, Drug Abuse
Keywords: Suboxone, Subutex, Buprenorphine, Naloxone
Study type: Observational
Recruitment status: Completed
Enrolment: 384 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 29 Jul 2008 (estimated)
Results: Posted 5 Apr 2012

Clinical summary

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

Detailed description

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

Study design

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

Arm	Type	Receives
Suboxone	–	Drug: Buprenorphine/NaloxonePatients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Opioid-dependent patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.

Key inclusion criteria (1 listed)

Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Key exclusion criteria (1 listed)

In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.

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/NaloxoneAlso: SCH 000484, SUBOXONE®Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine \& 0.5 mg naloxone and 8 mg buprenorphine \& 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.	Drug	Suboxone

Primary outcome

Retention Rate After 12 Months of Treatment With Suboxone
Time frame: 12 months
The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.

3 secondary outcomes

Dosage of SUBOXONE®
Time frame: Day 1 and Final Assessment (month 12 or time of dropout)
Take Home Prescriptions of SUBOXONE®
Time frame: Day 1 and Final Assessment (month 12 or time of dropout)
Drug Craving (Subjective Effects of Therapy)
Time frame: Baseline and Final Assessment (month 12 or time of dropout)

Results and safety

Results posted to the registry on 5 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suboxone	345	182

Primary outcome: Retention Rate After 12 Months of Treatment With Suboxone

Time frame: 12 months. Number (95% Confidence Interval). Unit: % of participants

Measure	Suboxone n = 345
Value	59.9 (54.9 to 65.1)

Population analysed: The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollement (day 0) until 30 days after end of observation = 13 months per patient maximum. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suboxone	10 of 384 (2.6%)	0 of 384 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Opioid-Related Disorders

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.

Markus Backmund, PD Dr. med. principal investigator

Praxiszentrum im Tal (pit), Munich (Germany)

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-Related Disorders and Opiate Dependence, 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 1 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 30 Apr 2012. 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 5 Apr 2012). 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?

Retention Rate After 12 Months of Treatment With Suboxone (time frame: 12 months). 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 NCT00723749.

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 Apr 2012.