Re-Treatment Study of Probuphine in Opioid Addiction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01262261
First received: December 15, 2010
Last updated: October 6, 2014
Last verified: October 2012

December 15, 2010
October 6, 2014
November 2010
November 2011   (final data collection date for primary outcome measure)
Number of subjects with Adverse Events (AEs) as a measure of safety [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]
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.
To evaluate the safety of Probuphine in subjects who have completed 24 weeks of treatment and who will be re-treated with Probuphine over an additional 24 weeks [ Time Frame: 1 to 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01262261 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic analyses through plasma buprenorphine concentration in subjects as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects retained as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects reporting illicit drug use as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Average daily dose of supplemental sublingual buprenorphine as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on SOWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on COWS as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings scores as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on Beck Depression Inventory (BDI-II) as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient-rated opioid use and problems Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician-rated severity of opioid use and symptoms Responder Analysis as a measure of efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Overall satisfaction with treatment reported on Patient Satisfaction Survey [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of Probuphine through pharmacokinetic analyses in subjects how have completed 24 weeks of treatment and who will be re-treated with Probuphine over an additional 24 weeks [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]
  • To evaluate additional measures of efficacy and safety in subjects who have completed 24 weeks of treatment with Probuphine, placebo implants, or sublingual buprenorphine, and who will be re-treated with Probuphine over an additional 24 weeks [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Re-Treatment Study of Probuphine in Opioid Addiction
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Opioid Dependency
Drug: Probuphine (buprenorphine implant)
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
Experimental: Probuphine
patients are first inducted on sublingual buprenorphine then switched to 4 Probuphine Implants
Intervention: Drug: Probuphine (buprenorphine implant)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262261
PRO-811
Yes
Titan Pharmaceuticals
Titan Pharmaceuticals
Not Provided
Principal Investigator: Katherine L. Beebe, Ph.D. Titan Pharmaceuticals
Titan Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP