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Opioid DependencePhase 3NCT00447564

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

A Phase 3 study testing Probuphine in people with Opioid Dependence, 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

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 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
18 sitesUnited States
Study dates
Oct 2006to Jul 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 65 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, 18-65 years of age
  • Meet 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)
  • 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
  • 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
Show all 14Show fewer
  • Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone
  • Current use of agents metabolized through 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
  • Meet 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 or dementia 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Behavioral Biology Research Unit, Johns Hopkins Bayview Campus

    Baltimore, Maryland, 21224

  • Wayne State University Department of Psychiatry and Behavioral Neurosciences

    Detroit, Michigan, 48207

  • Duke University Medical Center Addictions Program

    Durham, North Carolina, 27705

  • Providence Behavioral Health Services

    Everett, Washington, 98206

  • Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.

    Fall River, Massachusetts, 02720-6009

  • Amit Vijapura, MD and Associates

    Jacksonville, Florida, 32256

  • 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

  • New York VA Medical Center, NYU School of Medicine

    New York, New York, 10010

  • Addiction Institute of New York

    New York, New York, 10019

  • Scientific Clinical Research, Inc

    North Miami, Florida, 33161

  • North County Clinical Research

    Oceanside, California, 92056

  • Pahl Pharmaceutical Research, LLC

    Oklahoma City, Oklahoma, 73118

  • University of Pennsylvania Treatment Research Center

    Philadelphia, Pennsylvania, 19104

  • Northwest Behavioral Research Center

    Roswell, Georgia, 30076

  • Puget Sound Health Care Systems

    Seattle, Washington, 98108

  • Psych Care Consultants Research

    St Louis, Missouri, 63128

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center 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 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 patients with opioid dependence.

Being tested
Probuphine, placebo
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.

  • ProbuphineDrug

    4 implants

  • placeboDrug

    4 implants

Study groups in NCT00447564
Study groupRoleWhat they receive
Group AActive comparatorNot described
Receives: Drug: Probuphine
Group BPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids

    Measured: weeks 1-16

Secondary outcomes (19)

  1. The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids

    Measured: weeks 17-24

  2. Mean percent urines negative for illicit opioids

    Measured: weeks 1-16

  3. Mean percent urines negative for illicit opioids

    Measured: weeks 17-24

  4. Proportion (percent) of study completers

    Measured: weeks 1-16

  5. Proportion (percent) of study completers

    Measured: weeks 17-24

  6. Total number of weeks of abstinence

    Measured: weeks 1-16

  7. Total number of weeks of abstinence

    Measured: weeks 17-24

  8. Mean maximal period in weeks of continuous abstinence

    Measured: weeks 1-16

  9. Mean maximal period in weeks of continuous abstinence

    Measured: weeks 17-24

  10. Mean total score on the SOWS

    Measured: weeks 1-16

  11. Mean total score on the SOWS

    Measured: weeks 17-24

  12. Mean total score on the COWS

    Measured: weeks 1-16

  13. Mean total score on the COWS

    Measured: weeks 17-24

  14. Mean subjective opioid cravings assessment (VAS)

    Measured: weeks 1-16

  15. Mean subjective opioid cravings assessment (VAS)

    Measured: weeks 17-24

  16. Patient-rated Clinical Global Impression

    Measured: weeks 1-16

  17. Patient-rated Clinical Global Impression

    Measured: weeks 17-24

  18. Physician-rated Clinical Global Impression

    Measured: weeks 1-16

  19. Physician-rated Clinical Global Impression

    Measured: weeks 17-24

Timeline

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

  1. First posted14 Mar 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2008
  4. Study completionJul 2008

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447564
Sponsor's protocol ID
PRO-805
Status last verified
Jun 2017
First submitted
12 Mar 2007
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Probuphine in people with Opioid Dependence, 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 14 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. Some participants in this study may receive a placebo. 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?

The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids (time frame: weeks 1-16). 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 NCT00447564, which also lists 1 linked publication.

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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