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Opiate-related DisordersPhase 4NCT00684073

Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)

A Phase 4 study testing buprenorphine and buprenorphine/naloxone in people with Opiate-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.

Official record
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Trial summary

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
buprenorphine and buprenorphine/naloxone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jul 2007to Dec 2007
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Subject must be at least (>=) 18 years of age, of either sex.
  • Subject treated for opioid dependence with Subutex® with a stable daily dose between 2 mg and 16 mg daily, for at least 6 months.
  • Subject who do not inject/misuse their treatment with Subutex®.
  • Subject must be free of illicit opiate drug use as assessed by urine test performed prior to inclusion.
  • Subject must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications / products and adverse events to the investigator or designee.
  • Women of childbearing potential (includes women who are less than one year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterile (e.g., hysterectomy or tubal ligation).
  • Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. Women of childbearing potential must have a urine pregnancy test with negative result within 2 weeks prior to inclusion (as performed under control of the investigator or designee).

Who cannot join

  • Subject not eligible for treatment with Subutex® or Suboxone® according to the legal drug attachments.
  • Subject refusing to take the daily dose of the study medication under control in the center.
  • Subject unable to complete the evaluations.
  • Women who are pregnant or nursing.
  • Subject with a history of hypersensitivity to buprenorphine hydrochloride or naloxone hydrochloride dihydrate or any excipient of Subutex® or Suboxone®.
  • Subject with a current evidence of alcohol abuse.
Show all 18Show fewer
  • Subject with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens .
  • Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
  • Initiation or increase in the dose, within the past 7 days or scheduled during the study, of a treatment with:
  • benzodiazepines,
  • other depressants of the central nervous system: other morphine derivatives (analgesics, antitussives), certain antidepressive agents, sedative H1 antihistamines, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and clonidine-like agents and monoamine oxidase [MAO] inhibitors,
  • CYP3A4 inhibitors,
  • CYP3A4 inducers.
  • Subjects who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.
  • Subjects who have used any investigational product within 30 days prior to enrollment.
  • Subjects participating in another trial at the same time.
  • Subject who intend to donate blood during the study or within 3 months after study completion.
  • Subjects 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).

About this study

Official title: Evaluation of Preference for a Buprenorphine-based Maintenance Therapy, After a Switch From Buprenorphine Alone (Subutex®) to the Buprenorphine/Naloxone Combination (Suboxone®), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

Being tested
buprenorphine, 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.

  • buprenorphineDrug

    Also called Subutex®; SCH 028444

    2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study

  • buprenorphine/naloxoneDrug

    Also called Suboxone®; SCH 000484

    2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study

Study groups in NCT00684073
Study groupRoleWhat they receive
Subutex®/Suboxone®ExperimentalSubutex® for first two days of study followed by Suboxone® for last 3 days of study
Receives: Drug: buprenorphine; Drug: buprenorphine/naloxone

What is being measured

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

  1. Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).

    Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"

    Measured: Each treatment Day (post-dose on days 1-5)

Timeline

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

  1. First posted26 May 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684073
Sponsor's protocol ID
P05094
Other IDs
2006-006686-17
Status last verified
Mar 2023
First submitted
22 May 2008
Last updated
20 Mar 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing buprenorphine and buprenorphine/naloxone in people with Opiate-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 8 inclusion and 18 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.

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?

Yes. Results are posted in the registry (first posted 1 Jan 2010). 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?

Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). (time frame: Each treatment Day (post-dose on days 1-5)). 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 NCT00684073.

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.

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