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

NCT01903005 | Completed Phase 4 Results

• 1 other identifier: OX219-008
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 28

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.

Conditions

Opioid Dependence, on Agonist Therapy

Keywords

Opioid, Dependence, agonist, Buprenorphine, Naloxone

Outcome Measures

Primary Outcomes (4)

• Number of Patients Reporting Treatment-Emergent Adverse Events

  Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets

  Day 1 through week 24

• Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events

  Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets

  Day 1 through week 24

• Number of Patients Reporting Treatment-Emergent Serious Adverse Events

  Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets

  Day 1 throught week 24

• Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events

  Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets

  Day 1 through week 24

Secondary Outcomes (7)

• Retention in Treatment in the Safety Population

  Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24

• Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score

  Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint

• Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score

  Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint

• Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores

  Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint

• Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)

  Study Endpoint

Study Arms (1)

Open-label BNX sublingual tablets

EXPERIMENTAL

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.

Drug: Higher bioavailability BNX sublingual tablets

Interventions

Higher bioavailability BNX sublingual tablets DRUG

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

Also known as: OX219, Zubsolv, Buprenorphine/naloxone sublingual tablets

Open-label BNX sublingual tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Orexo AB: lead
• Worldwide Clinical Trials: collaborator

Study Sites (28)

Unknown Facility

Jefferson County, Alabama, United States

Location

Unknown Facility

Marion County, Alabama, United States

Location

Unknown Facility

Winston County, Alabama, United States

Location

Unknown Facility

Maricopa County, Arizona, United States

Location

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Los Angeles County, California, United States

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San Diego County, California, United States

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Broward County, Florida, United States

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Columbia County, Florida, United States

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Duval County, Florida, United States

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Jacksonville Metropolitan Area, Florida, United States

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Miami-Dade County, Florida, United States

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Unknown Facility

Orlando Metropolitan Area, Florida, United States

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Osceola County, Florida, United States

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Palm Beach County, Florida, United States

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DeKalb County, Georgia, United States

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Chicago Metropolitan Area, Illinois, United States

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Baltimore County, Maryland, United States

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Bristol County, Massachusetts, United States

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Rankin County, Mississippi, United States

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Saint Louis Metropolitan Area, Missouri, United States

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Warren County, New Jersey, United States

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Oklahoma County, Oklahoma, United States

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Portland Metropolitan Area, Oregon, United States

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Delaware County, Pennsylvania, United States

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Philadelphia County, Pennsylvania, United States

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Charleston County, South Carolina, United States

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Salt Lake County, Utah, United States

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Benton County, Washington, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Kent Hoffman, DO
• Organization: TRY Research

Suboxdoc1@yahoo.com

(407) 691-3960

Study Officials

• Kent Hoffman

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 19, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 28, 2015
• Results First Posted: October 28, 2015

Record last verified: 2015-09

Locations

US (28)