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Safety and Tolerability of Buprenorphine/Naloxone Film Strips

NCT00640835 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2012-11-12

Study results available
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Summary

This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Conditions

  • Opioid-Related Disorders

Interventions

DRUG

Buprenorphine/naloxone Film Strip

Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route

DRUG

Buprenorphine/naloxone Film Strip

Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Donald R. Jasinski, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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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 NCT00640835 on ClinicalTrials.gov