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Re-Treatment Study of Probuphine in Opioid Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01262261
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals

Brief 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 completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

Condition or disease Intervention/treatment Phase
Opioid Dependency Drug: Probuphine (buprenorphine implant) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probuphine
patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.




Primary Outcome Measures :
  1. Number of subjects with Adverse Events (AEs) as a measure of safety [ Time Frame: 29 weeks ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy [ Time Frame: 24 weeks ]
  2. Percent of subjects retained as a measure of efficacy [ Time Frame: 24 weeks ]
  3. Percent of subjects reporting illicit drug use as a measure of efficacy [ Time Frame: 24 weeks ]
  4. Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy [ Time Frame: 24 weeks ]
  5. Mean total score on SOWS as a measure of efficacy [ Time Frame: 24 weeks ]
  6. Mean total score on COWS as a measure of efficacy [ Time Frame: 24 weeks ]
  7. Mean subjective opioid cravings scores as a measure of efficacy [ Time Frame: 24 weeks ]
  8. Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy [ Time Frame: 24 weeks ]
  9. Patient-rated opioid use and problems Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ]
  10. Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ]
  11. Overall satisfaction with treatment reported on Patient Satisfaction Survey [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262261


Locations
Show Show 18 study locations
Sponsors and Collaborators
Titan Pharmaceuticals
Investigators
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Principal Investigator: Katherine L. Beebe, Ph.D. Titan Pharmaceuticals
Additional Information:
Publications:
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Responsible Party: Titan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01262261    
Other Study ID Numbers: PRO-811
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: June 2017
Keywords provided by Titan Pharmaceuticals:
opioid dependence
opioid addiction
buprenorphine
implant
methadone
heroin
suboxone
opioid pain medication
opioid withdrawal
Additional relevant MeSH terms:
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Opioid-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists