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

NCT ID: NCT00637000

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buprenorphine soluble film

Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.

Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours.

Group Type: EXPERIMENTAL

Buprenorphine soluble film

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.

Buprenorphine/naloxone soluble film

Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.

Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.

Group Type: EXPERIMENTAL

Buprenorphine/naloxone film strip

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.

Intervention Type: DRUG

Other Intervention Names

Subutex; Suboxone

Eligibility Criteria

Inclusion Criteria

Subject must:

• Provide written informed consent.
• Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence.
• Be male or female, 18 to 65 years of age, inclusive.
• If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control.

Exclusion Criteria

Subjects must not:

• Have participated in an experimental drug or device study within the last 30 days.
• Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment.
• If female, be breast feeding or lactating.
• Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
• Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia).
• Have current suicidal ideation.
• Have a Mini Mental Status Exam score less than 24.
• Have physical dependence on alcohol.
• Have physical dependence on sedative-hypnotics.
• Have active aphthous stomatitis.
• Have active oral herpes.
• Need on-going prescription medications that interact with the P450 3A4 (a member of the cytochrome P450 superfamily of enzymes) system.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indivior Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric C. Strain, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

RB-US-07-0002

Identifier Type: -

Identifier Source: org_study_id