Opioid DependencePhase 3PRO-807NCT00630201
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
A Phase 3 study testing Probuphine (buprenorphine implant) in people with Opioid Dependence, run by Titan Pharmaceuticals at 15 sites in United States.
Trial summary
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Probuphine (buprenorphine implant)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 15 sitesUnited States
- Study dates
- Oct 2007to Feb 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent prior to conduct of any study-related procedures
- Completed 24 weeks of treatment in PRO-805
- Deemed appropriate for entry into this extension study by the Investigator
- Females of childbearing potential and fertile males must use a reliable means of contraception
Who cannot join
- Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
- Current diagnosis of chronic pain requiring opioids for treatment
- Pregnant or lactating females
- 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 anti-coagulant therapy (such as warfarin) or an INR > 1.2
- 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 Investigator, 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
Baltimore, Maryland
Wayne State Univ. School of Medicine, Dept of Psychiatry & Behavioral Neuroscience
Detroit, Michigan
Duke Addictions Program
Durham, North Carolina, 27705
Providence Behavioral Health Services
Everett, Washington, 98201-1067
Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
Fall River, Massachusetts
Amit Vijapura, MD
Jacksonville, Florida, 32256
Fidelity Clinical Research, Inc.
Lauderhill, Florida
David Geffen School of Medicine at UCLA
Los Angeles, California
Synergy Clinical Research Center
National City, California, 91950
New York VA Medical Center, NYU School of Medicine
New York, New York
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, 19104
Puget Sound Health CareSystem
Seattle, Washington
Psych Care Consultants Research
St Louis, Missouri, 63128
About this study
Official title: An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.
- Conditions
- Opioid Dependence
- Being tested
- Probuphine (buprenorphine implant)
- 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, 6-month duration).
| Study group | Role | What they receive |
|---|---|---|
| Probuphine | Experimental | buprenorphine implant Receives: Drug: Probuphine (buprenorphine implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
Measured: approx. 26 weeks
Secondary outcomes (11)
Buprenorphine concentration in plasma
Measured: 24 weeks
Percent of urine samples that are negative for illicit opioids
Measured: 24 weeks
Percent of subjects retained as a measure of efficacy
Measured: 24 weeks
Percent of subjects reporting illicit drug use as a measure of efficacy
Measured: 24 weeks
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
Measured: 24 weeks
Mean total score on SOWS as a measure of efficacy
Measured: 24 weeks
Mean total score on COWS as a measure of efficacy
Measured: 24 weeks
Mean subjective opioid cravings scores as a measure of efficacy
Measured: 24 weeks
Mean composite score Drug Problems area of Addiction Severity Index
Measured: Baseline and End of Treatment
Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy
Measured: 24 weeks
Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT00630201
- Sponsor's protocol ID
- PRO-807
- Acronym
- PRO-807
- Status last verified
- Jun 2017
- First submitted
- 26 Feb 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
- An Open-Label, Multi-Center Extension Study Of Probuphine in Patients With Opioid Dependence
- ClinicalTrials.gov ID
- NCT00630201
- Acronym / sponsor ID
- PRO-807 / PRO-807
- 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
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Titan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 6 Mar 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.
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probuphine | Experimental | Drug: Probuphine (buprenorphine implant)buprenorphine implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily provide written informed consent prior to conduct of any study-related procedures
- Completed 24 weeks of treatment in PRO-805
- Deemed appropriate for entry into this extension study by the Investigator
- Females of childbearing potential and fertile males must use a reliable means of contraception
Key exclusion criteria (8 listed)
- Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
- Current diagnosis of chronic pain requiring opioids for treatment
- Pregnant or lactating females
- 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 anti-coagulant therapy (such as warfarin) or an INR > 1.2
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, 6-month duration). | Drug | Probuphine |
Primary outcome
Number of subjects with adverse events as a measure of safety
Time frame: approx. 26 weeks
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
11 secondary outcomes
Buprenorphine concentration in plasma
Time frame: 24 weeks
Percent of urine samples that are negative for illicit opioids
Time frame: 24 weeks
Percent of subjects retained as a measure of efficacy
Time frame: 24 weeks
Percent of subjects reporting illicit drug use as a measure of efficacy
Time frame: 24 weeks
Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy
Time frame: 24 weeks
Mean total score on SOWS as a measure of efficacy
Time frame: 24 weeks
Mean total score on COWS as a measure of efficacy
Time frame: 24 weeks
Mean subjective opioid cravings scores as a measure of efficacy
Time frame: 24 weeks
Mean composite score Drug Problems area of Addiction Severity Index
Time frame: Baseline and End of Treatment
Patient-rated Opioid use and Problems Responder Analysis as a measure of efficacy
Time frame: 24 weeks
Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
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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.
15 sites 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) in people with Opioid Dependence, run by Titan Pharmaceuticals at 15 sites 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 8 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 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 15 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 subjects with adverse events as a measure of safety (time frame: approx. 26 weeks). 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.