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A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants

NCT02180659 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2019-01-11

Study results available
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Summary

The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN.

The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.

Conditions

  • Opioid Dependence

Interventions

DRUG

sublingual buprenorphine tablets

DRUG

Buprenorphine implant

DRUG

placebo implants

DRUG

sublingual placebo tablets

Sponsors & Collaborators

  • Titan Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-05-31
Completion
2015-05-31

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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 NCT02180659 on ClinicalTrials.gov