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Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

NCT00447564 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2018-12-31

No results posted yet for this study

Summary

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.

Conditions

  • Opioid Dependence

Interventions

DRUG

Probuphine

4 implants

DRUG

placebo

4 implants

Sponsors & Collaborators

  • Titan Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447564 on ClinicalTrials.gov