NCT00637000

Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Detailed description

Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Subutex and Suboxone product: * Mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * Improvement in subject convenience and compliance by ensuring rapid disintegration. * Protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * Provision of a unit dose product format for hospital and institutional use. * Decreased product damage during shipping as compared to Subutex and Suboxone tablets.

Conditions

• Opioid-related Disorders

Interventions

Type	Name	Description
DRUG	Buprenorphine soluble film	Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment.
DRUG	Buprenorphine/naloxone film strip	Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment.
DRUG	Placebo	Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-03-17
• Last updated: 2017-06-05
• Results posted: 2014-05-09

Locations

1 site across 1 country: United States