Opioid-Related DisordersNCT00725608

Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

An observational study of Opioid-Related Disorders and Opiate Dependence, run by Indivior Inc. at 1 site in Austria.

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

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: 339 participants
Where: 1 siteAustria
Study dates: May 2008to Apr 2011
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: All patients on substitution therapy for opioid dependence willing to switch to Suboxone

Who may be able to join

All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.

Who cannot join

According to product information
In accordance with the product information pregnant women will be excluded.

Trial locations and contacts

1 site in 1 country.

Austria1 site

(Multiple sites in Austria) => Coordinating CRO: H&P GmbH
Vienna, 1070

Other trials in Austria

About this study

Official title: Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing

The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

Read the detailed description

Nonprobability sampling was done by invitation to volunteer.

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 Suboxone, SCH 000484
2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months

Study groups in NCT00725608
Study group	Role	What they receive
Patients		Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone) Receives: Drug: buprenorphine/naloxone

What is being measured

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

Retention Rate
The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study
Measured: month 6, month 12

Secondary outcomes (2)

Dosing of Suboxone (Buprenorphine Plus Naloxone)
One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.
Measured: day 1, month 6, month 12
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)
Measured: month 6, month 12

Timeline

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

May 2008Apr 2011

First posted30 Jul 2008 (estimated)
Study startMay 2008
Primary completionApr 2011
Study completionApr 2011

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: 339 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00725608
Sponsor's protocol ID: P05444
Status last verified: Jan 2017
First submitted: 25 Jul 2008
Last updated: 3 Mar 2017
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?

See locations

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All Opioid-Related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing
ClinicalTrials.gov ID: NCT00725608
Acronym / sponsor ID: P05444
Conditions: Opioid-Related Disorders, Opiate Dependence, Drug Abuse
Keywords: Suboxone, Subutex, Buprenorphine, Naloxone
Study type: Observational
Recruitment status: Completed
Enrolment: 339 participants (actual)
Lead sponsor: Indivior Inc.Industry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 23 Mar 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.

Study design

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

Arm	Type	Receives
Patients	–	Drug: buprenorphine/naloxoneOpioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients on substitution therapy for opioid dependence willing to switch to Suboxone

Key inclusion criteria (2 listed)

All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.

Key exclusion criteria (2 listed)

According to product information
In accordance with the product information pregnant women will be excluded.

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: Suboxone, SCH 0004842/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months	Drug	Patients

Primary outcome

Retention Rate
Time frame: month 6, month 12
The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study

2 secondary outcomes

Dosing of Suboxone (Buprenorphine Plus Naloxone)
Time frame: day 1, month 6, month 12
Dispensing of Suboxone (Buprenorphine Plus Naloxone)
Time frame: month 6, month 12

Results and safety

Results posted to the registry on 23 Mar 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
Opioid Dependent Patients	307	140

Primary outcome: Retention Rate

Time frame: month 6, month 12. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Opioid Dependent Patients n = 307
Retention rate after 6 months of treatment	57.3 (51.8 to 62.9)
Retention rate after 12 months of treatment	45.6 (40.0 to 51.2)

Population analysed: All eligible datasets were included in analysis population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for total observational time of each patient: from start of treatment until end of observation or date of early discontinuation, respectively - maximum period 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Opioid Dependent Patients	2 of 339 (0.6%)	49 of 339 (14.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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
Opioid Use Disorder
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.

Gabriele Fischer, Prof. Dr. principal investigator

Medical University of Vienna

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-Related Disorders and Opiate Dependence, run by Indivior Inc. at 1 site in Austria.

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 2 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 3 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 Austria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 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 (time frame: month 6, month 12). 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 NCT00725608.

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 3 Mar 2017.