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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Titan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01114308
First received: April 27, 2010
Last updated: January 25, 2013
Last verified: October 2012

April 27, 2010
January 25, 2013
April 2010
May 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]
To confirm the efficacy of Probuphine versus placebo in adults with DSM-IV-TR defined opioid dependence through the assessment of thrice-weekly urine toxicology results. [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01114308 on ClinicalTrials.gov Archive Site
  • CDF of the percent of urine samples negative for opioids from weeks 1-16 [ Time Frame: 1-16 weeks ] [ Designated as safety issue: No ]
  • CDF of the percent of urine samples negative for opioids from weeks 17-24 [ Time Frame: 17-24 weeks ] [ Designated as safety issue: No ]
  • Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of Probuphine versus Placebo in adult subjects with DSM-IV-TR defined opioid dependence through the assessment of thrice-weekly urine toxicology results. [ Time Frame: 1-16 weeks and 17-24 weeks ] [ Designated as safety issue: No ]
  • To demonstrate non-inferiority of Probuphine versus sublingual buprenorphine in adult subjects with DSM-IV-TR defined Opioid dependence through the assessment of thrice-weekly urine toxicology results. [ Time Frame: 1-24 weeks ] [ Designated as safety issue: No ]
  • Percent urines negative for illicit opioids [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of study completers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on the SOWS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total score on the COWS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean subjective opioid craving assessment using Visual Analog Scale (VAS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient-rated Clinical Global Improvement (CGI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Physician-rated Clinical Global Improvement (CGI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean total number of weeks of abstinence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean maximum period of continuous abstinence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
 
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opioid Dependency
  • Drug: Probuphine (buprenorphine implant)
    Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
  • Drug: placebo implant
    Implant contains ethylene vinyl acetate
  • Drug: Buprenorphine
    sublingual buprenorphine/naloxone tablets
    Other Name: Suboxone
  • Experimental: Probuphine
    Patients are first inducted on SL BPN then switched to 4 buprenorphine implants
    Intervention: Drug: Probuphine (buprenorphine implant)
  • Placebo Comparator: placebo implant
    patients are first inducted on SL BPN then switched to 4 placebo implants
    Intervention: Drug: placebo implant
  • Active Comparator: sublingual buprenorphine
    patients are inducted on SL BPN, then continue on SL BPN
    Intervention: Drug: Buprenorphine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
287
May 2011
May 2011   (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-TR criteria for current opioid dependence
  • Females of childbearing potential or a fertile male, must use a reliable means of contraception

Exclusion Criteria:

  • 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
  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114308
PRO-806, 1RC2DA028910-01
Yes
Titan Pharmaceuticals
Titan Pharmaceuticals
National Institute on Drug Abuse (NIDA)
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