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Opioid DependencyPhase 3NCT01262261

Re-Treatment Study of Probuphine in Opioid Addiction

A Phase 3 study testing Probuphine (buprenorphine implant) in people with Opioid Dependency, run by Titan Pharmaceuticals at 18 sites in United States.

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

Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Dependency
What is being tested?
Probuphine (buprenorphine implant)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
18 sitesUnited States
Study dates
Nov 2010to Nov 2011
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

  • Subject has voluntarily provided written informed consent prior to conducting any study-related procedures
  • Completion of 24 weeks of treatment in PRO-806
  • Subject has been deemed appropriate for entry into this extension study by the investigator
  • Females of childbearing potential must be willing to use a reliable means of contraception during the entire study.

Who cannot join

  • An aspartate aminotransferase (AST) levels ≥ 3 X the upper limit of normal, alanine aminotransferase (ALT) levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the screening laboratory assessments
  • A current diagnosis of chronic pain requiring opioids for treatment
  • A pregnant or lactating female
  • Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
  • A history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
  • A significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
  • Any current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • BPRU, Behavioral Biology Research Center

    Baltimore, Maryland, 21224

  • University of Vermont

    Burlington, Vermont, 05401

  • Carolina Clinical Trials, Inc.

    Charleston, South Carolina, 29407

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Providence Behavioral Health Services

    Everett, Washington, 98201

  • Stanley Street Treatment and Resources, Inc

    Fall River, Massachusetts, 02720

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Amit Vijapura, MD

    Jacksonville, Florida, 32256

  • Operation PAR, Inc. - TC Campus

    Largo, Florida, 33771

  • Fidelity Clinical Research

    Lauderhill, Florida, 33319

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90025

  • Synergy Clinical Research Center

    National City, California, 91950

  • St. Luke's Roosevelt Hospital Center

    New York, New York, 10025

  • Scientific Clinical Research, Inc.

    North Miami, Florida, 33161

  • North County Clinical Research

    Oceanside, California, 92056

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Psych Care Consultants Research

    St Louis, Missouri, 63128

  • Friends Research Institute

    Torrance, California, 90502

Other trials in United States

About this study

Official title: A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction

Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

Being tested
Probuphine (buprenorphine implant)
Keywords
opioid dependence, opioid addiction, buprenorphine, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal
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.

Study groups in NCT01262261
Study groupRoleWhat they receive
ProbuphineExperimentalpatients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Receives: Drug: Probuphine (buprenorphine implant)

What is being measured

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

  1. Number of subjects with Adverse Events (AEs) as a measure of safety

    AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.

    Measured: 29 weeks

Secondary outcomes (11)

  1. Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy

    Measured: 24 weeks

  2. Percent of subjects retained as a measure of efficacy

    Measured: 24 weeks

  3. Percent of subjects reporting illicit drug use as a measure of efficacy

    Measured: 24 weeks

  4. Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy

    Measured: 24 weeks

  5. Mean total score on SOWS as a measure of efficacy

    Measured: 24 weeks

  6. Mean total score on COWS as a measure of efficacy

    Measured: 24 weeks

  7. Mean subjective opioid cravings scores as a measure of efficacy

    Measured: 24 weeks

  8. Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy

    Measured: 24 weeks

  9. Patient-rated opioid use and problems Responder Analysis as a measure of efficacy

    Measured: 24 weeks

  10. Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy

    Measured: 24 weeks

  11. Overall satisfaction with treatment reported on Patient Satisfaction Survey

    Measured: 24 weeks

Timeline

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

  1. First posted17 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2011
  4. Study completionNov 2011

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262261
Sponsor's protocol ID
PRO-811
Status last verified
Jun 2017
First submitted
15 Dec 2010
Last updated
31 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, Rosenthal RN, Beebe KL. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010 Oct 13;304(14):1576-83. doi: 10.1001/jama.2010.1427.

    PubMed 20940383

  • White J, Bell J, Saunders JB, Williamson P, Makowska M, Farquharson A, Beebe KL. Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. Drug Alcohol Depend. 2009 Jul 1;103(1-2):37-43. doi: 10.1016/j.drugalcdep.2009.03.008. Epub 2009 Apr 28.

    PubMed 19403243

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Probuphine (buprenorphine implant) in people with Opioid Dependency, run by Titan Pharmaceuticals at 18 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 7 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 18 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 (AEs) as a measure of safety (time frame: 29 weeks). 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 NCT01262261, which also lists 2 linked publications.

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.

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