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Opioid DependencyPhase 3NCT01114308

A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

A Phase 3 study testing Probuphine (buprenorphine implant) and Buprenorphine in people with Opioid Dependency, run by Titan Pharmaceuticals at 20 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 implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. 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) and Buprenorphine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
287 participants
Where
20 sitesUnited States
Study dates
Apr 2010to May 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

  • 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-TR criteria for current opioid dependence
  • Females of childbearing potential or a fertile male, must use a reliable means of contraception

Who cannot join

  • Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
  • Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
  • Current diagnosis of chronic pain requiring opioids for treatment
  • Candidates for short-term opioid treatment (<6 months) only, or opioid detoxification therapy
  • Pregnant or lactating female?
  • Previous hypersensitivity or allergy to BPN, EVA-containing substances, or naloxone
Show all 15Show fewer
  • 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)
  • History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
  • Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
  • 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
  • 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
  • Exposure to any investigational drug within the previous 8 weeks
  • Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial
  • Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments
  • Clinically significant low platelet count on the screening laboratory assessments

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • BPRU, Behavioral Biology Research Center

    Baltimore, Maryland, 21224

  • University of Vermont

    Burlington, Vermont, 05401

  • Carolina Clinical Trials, Inc.

    Charleston, South Carolina, 29407

  • University of Cincinnati

    Cincinnati, Ohio, 45220

  • Duke University, Duke Addictions Program

    Durham, North Carolina, 27705

  • Providence Behavioral Health Services

    Everett, Washington, 98201

  • SSTAR: Stanley Street Treatment and Resources, Inc.

    Fall River, Massachusetts, 02720-6009

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Amit Vijapura, MD

    Jacksonville, Florida, 32256

  • Operation PAR, Inc. - TC Campus

    Largo, Florida, 33771

  • Fidelity Clinical Research, Inc.

    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

  • 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

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Friends Research Institute

    Torrance, California, 90502

Other trials in United States

About this study

Official title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.

Being tested
Probuphine (buprenorphine implant), placebo implant, Buprenorphine
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.

  • placebo implantDrug

    Implant contains ethylene vinyl acetate

  • BuprenorphineDrug

    Also called Suboxone

    sublingual buprenorphine/naloxone tablets

Study groups in NCT01114308
Study groupRoleWhat they receive
ProbuphineExperimentalPatients are first inducted on SL BPN then switched to 4 buprenorphine implants
Receives: Drug: Probuphine (buprenorphine implant)
placebo implantPlacebo comparatorpatients are first inducted on SL BPN then switched to 4 placebo implants
Receives: Drug: placebo implant
sublingual buprenorphineActive comparatorpatients are inducted on SL BPN, then continue on SL BPN
Receives: Drug: Buprenorphine

What is being measured

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

  1. CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24

    Measured: 1-24 weeks

  2. CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups

    Measured: 1-24 weeks

Secondary outcomes (3)

  1. CDF of the percent of urine samples negative for opioids from weeks 1-16

    Measured: 1-16 weeks

  2. CDF of the percent of urine samples negative for opioids from weeks 17-24

    Measured: 17-24 weeks

  3. Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN

    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 posted3 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2011
  4. Study completionMay 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114308
Sponsor's protocol ID
PRO-806
Other IDs
1RC2DA028910-01
Status last verified
Jun 2017
First submitted
27 Apr 2010
Last updated
31 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Rosenthal RN, Ling W, Casadonte P, Vocci F, Bailey GL, Kampman K, Patkar A, Chavoustie S, Blasey C, Sigmon S, Beebe KL. Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone. Addiction. 2013 Dec;108(12):2141-9. doi: 10.1111/add.12315. Epub 2013 Sep 18.

    PubMed 23919595

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Probuphine (buprenorphine implant) and Buprenorphine in people with Opioid Dependency, run by Titan Pharmaceuticals at 20 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 15 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 20 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?

CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (time frame: 1-24 weeks). The study lists 2 primary outcomes in all. 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 NCT01114308, 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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