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CompletedNCT00447564Updated Dec 31, 2018

Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

A Phase 3 interventional study of Probuphine and placebo in Opioid Dependence, sponsored by Titan Pharmaceuticals. Completed at 18 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-31.

Sponsored by Titan Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Opioid Dependence

Keywords

  • opioid dependence
  • opioid addiction
  • buprenorphine
  • methadone
  • heroin
  • implant
  • opioid withdrawal
  • opioid pain medication
  • suboxone
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 163 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Titan Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
163 participants (actual)

Study arms

  • Active comparator
    Group A

    Drug: Probuphine

  • Placebo comparator
    Group B

    Drug: placebo

Interventions

  • DrugProbuphine

    4 implants

  • Drugplacebo

    4 implants

06

What researchers measure

Primary outcomes

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

    Time frame: weeks 1-16

Secondary outcomes

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

    Time frame: weeks 17-24

  2. Mean percent urines negative for illicit opioids

    Time frame: weeks 1-16

  3. Mean percent urines negative for illicit opioids

    Time frame: weeks 17-24

  4. Proportion (percent) of study completers

    Time frame: weeks 1-16

  5. Proportion (percent) of study completers

    Time frame: weeks 17-24

  6. Total number of weeks of abstinence

    Time frame: weeks 1-16

  7. Total number of weeks of abstinence

    Time frame: weeks 17-24

  8. Mean maximal period in weeks of continuous abstinence

    Time frame: weeks 1-16

  9. Mean maximal period in weeks of continuous abstinence

    Time frame: weeks 17-24

  10. Mean total score on the SOWS

    Time frame: weeks 1-16

  11. Mean total score on the SOWS

    Time frame: weeks 17-24

  12. Mean total score on the COWS

    Time frame: weeks 1-16

  13. Mean total score on the COWS

    Time frame: weeks 17-24

  14. Mean subjective opioid cravings assessment (VAS)

    Time frame: weeks 1-16

  15. Mean subjective opioid cravings assessment (VAS)

    Time frame: weeks 17-24

  16. Patient-rated Clinical Global Impression

    Time frame: weeks 1-16

  17. Patient-rated Clinical Global Impression

    Time frame: weeks 17-24

  18. Physician-rated Clinical Global Impression

    Time frame: weeks 1-16

  19. Physician-rated Clinical Global Impression

    Time frame: weeks 17-24

07

Study locations

18 sites
  • David Geffen School of Medicine at UCLA
    Los Angeles, California 90025, United States
  • Synergy Clinical Research Center
    National City, California 91950, United States
  • North County Clinical Research
    Oceanside, California 92056, United States
  • Amit Vijapura, MD and Associates
    Jacksonville, Florida 32256, United States
  • Fidelity Clinical Research
    Lauderhill, Florida 33319, United States
  • Scientific Clinical Research, Inc
    North Miami, Florida 33161, United States
  • Northwest Behavioral Research Center
    Roswell, Georgia 30076, United States
  • Behavioral Biology Research Unit, Johns Hopkins Bayview Campus
    Baltimore, Maryland 21224, United States
  • Dual Diagnosis Unit, SSTAR: Stanley Street Treatment and Resources, Inc.
    Fall River, Massachusetts 02720-6009, United States
  • Wayne State University Department of Psychiatry and Behavioral Neurosciences
    Detroit, Michigan 48207, United States
  • Psych Care Consultants Research
    Saint Louis, Missouri 63128, United States
  • New York VA Medical Center, NYU School of Medicine
    New York, New York 10010, United States
  • Addiction Institute of New York
    New York, New York 10019, United States
  • Duke University Medical Center Addictions Program
    Durham, North Carolina 27705, United States
  • Pahl Pharmaceutical Research, LLC
    Oklahoma City, Oklahoma 73118, United States
  • University of Pennsylvania Treatment Research Center
    Philadelphia, Pennsylvania 19104, United States
  • Providence Behavioral Health Services
    Everett, Washington 98206, United States
  • Puget Sound Health Care Systems
    Seattle, Washington 98108, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00447564
Lead sponsor
Titan Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 14, 2007
Start date
Oct 2006
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Dec 31, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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