Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

NCT ID: NCT01903005

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 668 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Detailed Description

This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 [NCT01908842] or OX219-007 [NCT01848054]). The total duration of study treatment was 24 weeks.

Conditions

Opioid Dependence, on Agonist Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label BNX sublingual tablets

Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.

Group Type: EXPERIMENTAL

Higher bioavailability BNX sublingual tablets

Intervention Type: DRUG

Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Interventions

Higher bioavailability BNX sublingual tablets

Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Intervention Type: DRUG

Other Intervention Names

OX219; Zubsolv; Buprenorphine/naloxone sublingual tablets

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form.
• Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets (OX219-006 or OX219-007).
• Female patients of child bearing potential who used a reliable method of contraception (hormonal, condom with spermicide, intrauterine device) during the previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study. Females who are not of child-bearing potential who are either surgically sterile (by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or postmenopausal, as defined by being at least 50 years of age and having had an absence of menses for at least 2 years, were also eligible.

Exclusion Criteria

• Females who are pregnant (positive pregnancy test result) or lactating, or planning to become pregnant during the study.
• Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
• Participants who are participating in any other clinical study in which medication(s) are being delivered or who had used an investigational drug or device within the last 30 days.
• Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug, or history of any drug hypersensitivity or intolerance that, in the opinion of the investigator, would compromise the safety of the subject or the study.
• Participant with a contra-indicated serious medical condition.
• Participants who are at suicidal risk as determined by any of the following: a history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale (C-SSRS).

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

Sponsors

Worldwide Clinical Trials

OTHER

Sponsor Role: collaborator

Orexo AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kent Hoffman

Role: PRINCIPAL_INVESTIGATOR

TRY Research, 406 Lake Howell Road, Maitland, Florida 32751

Locations

Jefferson County, Alabama, United States

Marion County, Alabama, United States

Winston County, Alabama, United States

Maricopa County, Arizona, United States

Los Angeles County, California, United States

San Diego County, California, United States

Broward County, Florida, United States

Columbia County, Florida, United States

Duval County, Florida, United States

Jacksonville Metropolitan Area, Florida, United States

Miami-Dade County, Florida, United States

Orlando Metropolitan Area, Florida, United States

Osceola County, Florida, United States

Palm Beach County, Florida, United States

DeKalb County, Georgia, United States

Chicago Metropolitan Area, Illinois, United States

Baltimore County, Maryland, United States

Bristol County, Massachusetts, United States

Rankin County, Mississippi, United States

Saint Louis Metropolitan Area, Missouri, United States

Warren County, New Jersey, United States

Oklahoma County, Oklahoma, United States

Portland Metropolitan Area, Oregon, United States

Delaware County, Pennsylvania, United States

Philadelphia County, Pennsylvania, United States

Charleston County, South Carolina, United States

Salt Lake County, Utah, United States

Benton County, Washington, United States

Countries

United States

Other Identifiers

OX219-008

Identifier Type: -

Identifier Source: org_study_id