A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence

NCT00768482 | Terminated Phase 3 DMC

• 1 other identifier: PRO-810
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).

Conditions

Opioid Dependence

Keywords

opioid dependence; opioid addiction; buprenorphine; methadone; heroin; implant; opioid withdrawal; opioid pain medication; suboxone

Outcome Measures

Primary Outcomes (1)

• Plasma BPN AUC(0-24)during 24 hours at steady state.

  Day -1, Day -2 and Week 4

Secondary Outcomes (5)

• Plasma BPN and NorBPN Cmax

  week 4

• Time to maximum plasma BPN and NorBPN concentration (tmax)

  Day -2, Day -1 and Day 1

• Plasma BPN and NorBPN AUC(0-24) during 24 hours at steady state

  week 4

• Change in plasma BPN concentration

  24 weeks

• Number of subjects with adverse events as a measure of safety and tolerability

  approx. 11 weeks (due to study termination)

Study Arms (1)

Probuphine

EXPERIMENTAL

Patients are first inducted on SL BPN, and then switched to 4 Probuphine implants

Drug: Probuphine (buprenorphine implant); Drug: Sublingual Buprenorphine

Interventions

Probuphine (buprenorphine implant) DRUG

Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants)

Probuphine

Sublingual Buprenorphine DRUG

16 mg/day, QD

Probuphine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provide written informed consent prior to the conduct of any study related procedures
• Male or female, 18-75 years of age
• Meet the DSM-IV criteria for current opioid dependence
• Females of childbearing potential and fertile males must use a reliable means of contraception

You may not qualify if:

• Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
• 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 Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
• Current history of coagulopathy, and/or anti-coagulant therapy (such as warfarin)
• Meet the 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, cognitive impairment, or other factors 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
• Previous participation in a Probuphine clinical trial
• Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal

Sponsors & Collaborators

• Titan Pharmaceuticals: lead

Study Sites (1)

Segal Institute For Clinical Research

Fort Lauderdale, Florida, 33308, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 31, 2018

Record last verified: 2017-06

Locations

US (1)