Opioid DependencePhase 3PRO-810NCT00768482
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
A Phase 3 study testing Probuphine (buprenorphine implant) and Sublingual Buprenorphine in people with Opioid Dependence, run by Titan Pharmaceuticals at 1 site in United States.
Trial summary
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Probuphine (buprenorphine implant) and Sublingual Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent prior to the conduct of any study related procedures
- Male or female, 18-75 years of age
- Meet the DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of contraception
Who cannot join
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- Received treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
- Current diagnosis of chronic pain requiring opioids for treatment
- Candidates for only short term opioid treatment or opioid detoxification therapy
- Pregnant or lactating females
- Previous hypersensitivity or allergy to BPN or EVA-containing substances or naloxone
Show all 16Show fewer
- Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
- Current history of coagulopathy, and/or anti-coagulant therapy (such as warfarin)
- Meet the DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
- Current use of benzodiazepines other than physician prescribed use
- Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
- Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
- Participated in a clinical study within the previous 8 weeks
- Previous participation in a Probuphine clinical trial
- Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal
- Clinically significant low platelet count with current history of coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Segal Institute For Clinical Research
Fort Lauderdale, Florida, 33308
About this study
Official title: A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State in Patients With Opioid Dependence
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
Read the detailed description
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
- Conditions
- Opioid Dependence
- Being tested
- Probuphine (buprenorphine implant), Sublingual Buprenorphine
- Keywords
- opioid dependence, opioid addiction, buprenorphine, methadone, heroin, implant, opioid withdrawal, opioid pain medication, suboxone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probuphine (buprenorphine implant)Drug
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants)
Sublingual BuprenorphineDrug
16 mg/day, QD
| Study group | Role | What they receive |
|---|---|---|
| Probuphine | Experimental | Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants Receives: Drug: Probuphine (buprenorphine implant); Drug: Sublingual Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma BPN AUC(0-24)during 24 hours at steady state.
Measured: Day -1, Day -2 and Week 4
Secondary outcomes (5)
Plasma BPN and NorBPN Cmax
Measured: week 4
Time to maximum plasma BPN and NorBPN concentration (tmax)
Measured: Day -2, Day -1 and Day 1
Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state
Measured: week 4
Change in plasma BPN concentration
Measured: 24 weeks
Number of subjects with adverse events as a measure of safety and tolerability
Adverse events that occurred after the signing of informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and Serious AEs until resolution or stabilization, were followed.
Measured: approx. 11 weeks (due to study termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: This study was terminated for reasons not related to efficacy or safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies 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 3
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Titan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768482
- Sponsor's protocol ID
- PRO-810
- Acronym
- PRO-810
- Status last verified
- Jun 2017
- First submitted
- 7 Oct 2008
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Cross-Over, Open-Label Study of the Relative Bioavailability of Probuphine Versus Buprenorphine Sublingual Tablets at Steady State in Patients With Opioid Dependence
- ClinicalTrials.gov ID
- NCT00768482
- Acronym / sponsor ID
- PRO-810 / PRO-810
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, opioid addiction, buprenorphine, methadone, heroin, implant, opioid withdrawal, opioid pain medication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated for reasons not related to efficacy or safety
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Titan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Oct 2008 (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.
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
Detailed description
This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probuphine | Experimental | Drug: Probuphine (buprenorphine implant), Drug: Sublingual BuprenorphinePatients are first inducted on SL BPN, and then switched to 4 Probuphine implants |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily provide written informed consent prior to the conduct of any study related procedures
- Male or female, 18-75 years of age
- Meet the DSM-IV criteria for current opioid dependence
- Females of childbearing potential and fertile males must use a reliable means of contraception
Key exclusion criteria (16 listed)
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
- Received treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
- Current diagnosis of chronic pain requiring opioids for treatment
- Candidates for only short term opioid treatment or opioid detoxification therapy
- Pregnant or lactating females
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 |
|---|---|---|
| Probuphine (buprenorphine implant)Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants) | Drug | Probuphine |
| Sublingual Buprenorphine16 mg/day, QD | Drug | Probuphine |
Primary outcome
Plasma BPN AUC(0-24)during 24 hours at steady state.
Time frame: Day -1, Day -2 and Week 4
5 secondary outcomes
Plasma BPN and NorBPN Cmax
Time frame: week 4
Time to maximum plasma BPN and NorBPN concentration (tmax)
Time frame: Day -2, Day -1 and Day 1
Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state
Time frame: week 4
Change in plasma BPN concentration
Time frame: 24 weeks
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: approx. 11 weeks (due to study termination)
Results and safety
The study was stopped early (reason given: This study was terminated for reasons not related to efficacy or safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probuphine (buprenorphine implant) and Sublingual Buprenorphine in people with Opioid Dependence, run by Titan Pharmaceuticals at 1 site in United States.
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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 31 Dec 2018. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: This study was terminated for reasons not related to efficacy or safety). Results are not available in the source record.
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?
Plasma BPN AUC(0-24)during 24 hours at steady state. (time frame: Day -1, Day -2 and Week 4). 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 31 Dec 2018.