Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00447564
First received: March 12, 2007
Last updated: October 18, 2012
Last verified: October 2012

March 12, 2007
October 18, 2012
October 2006
July 2008   (final data collection date for primary outcome measure)
The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00447564 on ClinicalTrials.gov Archive Site
  • The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean percent urines negative for illicit opioids [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean percent urines negative for illicit opioids [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Proportion (percent) of study completers [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Proportion (percent) of study completers [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Total number of weeks of abstinence [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Total number of weeks of abstinence [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean maximal period in weeks of continuous abstinence [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean maximal period in weeks of continuous abstinence [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean total score on the SOWS [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean total score on the SOWS [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean total score on the COWS [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean total score on the COWS [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings assessment (VAS) [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Mean subjective opioid cravings assessment (VAS) [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Patient-rated Clinical Global Impression [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Patient-rated Clinical Global Impression [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
  • Physician-rated Clinical Global Impression [ Time Frame: weeks 1-16 ] [ Designated as safety issue: No ]
  • Physician-rated Clinical Global Impression [ Time Frame: weeks 17-24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Opioid Dependence
  • Drug: Probuphine
    4 implants
  • Drug: placebo
    4 implants
  • Active Comparator: Group A
    Intervention: Drug: Probuphine
  • Placebo Comparator: Group B
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
July 2008
July 2008   (final data collection date for primary outcome measure)

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:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00447564
PRO-805
Yes
Titan Pharmaceuticals
Titan Pharmaceuticals
Not Provided
Not Provided
Titan Pharmaceuticals
October 2012

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