Study to Assess OX219 (Buprenorphine/Naloxone) for the Induction of Treatment of Opioid Dependence

This study has been completed.
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Orexo AB
ClinicalTrials.gov Identifier:
NCT01848054
First received: May 2, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to assess how effective starting buprenorphine treatment of opioid dependence directly on the buprenorphine/naloxone combination OX219 is, compared to starting treatment on buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on day 3.

Patients will be screened and eligible patients will be randomized within 0-14 days after screening, and followed for 28 days of treatment. Effectiveness of treatment will be assessed, including:

  • How long patients retain in treatment
  • Assessment of opioid withdrawal symptoms
  • Assessment of cravings for opioids
  • Assessment of urine drug screens negative for opioids

Condition Intervention Phase
Opioid-Related Disorders,
Opiate Dependence
Drug: OX219 buprenorphine/naloxone
Drug: Buprenorphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence

Resource links provided by NLM:


Further study details as provided by Orexo AB:

Primary Outcome Measures:
  • Retention in treatment [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    The proportion of patients in each arm completing the two day induction phase and receive treatment on day 3.


Secondary Outcome Measures:
  • Retention in treatment at each study visit [ Time Frame: Day 2, 3, 4, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
    For each study visit, the proportion of patients in each arm receiving study treatment on the visit day or at a later visit day.

  • Retention in treatment by study day [ Time Frame: Day 1-29 ] [ Designated as safety issue: No ]
    The proportion of patients retaining in treatment by study day

  • Clinical Opiate Withdrawal Scale score [ Time Frame: Pre-dose and 0.5, 1.5, 3 and 6 h post dose on day 1; Pre-dose only on day 2, 3, 4, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
    Score of standardized clinical scale for assessment of opioid withdrawal symptoms in patients

  • Subjective Opiate Withdrawal Scale score [ Time Frame: Pre-dose and 0.5, 1.5, 3 and 6 h post dose on day 1; Pre-dose only on day 2, 3, 4, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
    Score of standardized subjective scale for assessment of opioid withdrawal symptoms by patients

  • Urine drug screens negative for opioids [ Time Frame: Day 1, 2, 3, 4, 8, 15, 22, 29 ] [ Designated as safety issue: No ]
    Percentage of urine drug screens negative for opioids other than buprenorphine at each study visit

  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Patient assessment of improvement/deterioration of opioid dependence severity compared to baseline (day 1).

  • Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Investigator's assessment of improvement/deterioration of opioid dependence severity compared to baseline (day 1).

  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: Screening, Day 29 ] [ Designated as safety issue: No ]
    Investigator's assessment of opioid dependence severity.


Other Outcome Measures:
  • Addiction Severity Index - Lite (ASI-Lite) [ Time Frame: Screening, Day 29 ] [ Designated as safety issue: No ]
    Structured interview to evaluate severity of addiction.

  • Short Form 36 v2 (SF-36) [ Time Frame: Screening, Day 29 ] [ Designated as safety issue: No ]
    Patient general quality of life questionnaire

  • Work productivity/activity impairment: Specific health problem questionnaire (WPAI:SHP) [ Time Frame: Screening, Day 29 ] [ Designated as safety issue: No ]
    Patient questionnaire to evaluate the influence of opioid dependence on work capacity / other activities


Enrollment: 310
Study Start Date: June 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OX219 Induction

Day 1-2: Induction on OX219 buprenorphine/naloxone sublingual tablets (blinded).

Day 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label).

Drug: OX219 buprenorphine/naloxone
OX219 buprenorphine/naloxone sublingual tablets
Active Comparator: Buprenorphine induction

Day 1-2: Induction on buprenorphine sublingual tablets (blinded).

Day 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label).

Drug: OX219 buprenorphine/naloxone
OX219 buprenorphine/naloxone sublingual tablets
Drug: Buprenorphine
Buprenorphine sublingual tablets

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to read, comprehend, and sign the informed consent form and willingly provide written informed consent
  • Prepared to engage in opioid replacement therapy and to abstain from opioid utilization other than the study drug, and from other illicit drugs.
  • Male or female, 18 to 65 years old, inclusive.
  • Meet the criteria for opioid dependence as defined in the DSM-IV-TR, in the past 12 months.
  • Have a BUP-negative urine drug screen and/or urine dipstick result before randomization.
  • Have a negative urine pregnancy test
  • For females of childbearing potential: Using a reliable method of contraception (e.g., hormonal, condom with spermicide, intrauterine device [IUD]) after the screening visit and for the duration of the study.
  • For participants receiving opioids for pain, clearance from their prescribing physician to be withdrawn from their prescribed opioids.
  • Generally good health as determined by the investigator
  • Subjects should demonstrate at least mild withdrawal symptoms (defined as a COWS score >9) at Day 1 predose.

Exclusion Criteria:

  • Females who are pregnant or lactating, or planning to be pregnant during study.
  • Any previous prescribed treatment with BUP monotherapy (e.g., generic BUP SL tablets).
  • Prescribed treatment with BUP or NAL within 90 days prior to start of treatment.
  • Methadone patients with any daily dose over 30 mg during the past week and who received the last dose of methadone less than 30 hours prior to start of treatment.
  • Participants who are unwilling or unable to comply with the requirements of the protocol
  • Participants who are participating in any other clinical study in which medication(s) are being delivered or who have used an investigational drug or device within the last 30 days.
  • Participants with any known allergy or sensitivity or intolerance to BUP, NAL, or any related drug
  • Participants who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
  • Participants with serious untreated Axis I DSM-IV-TR psychiatric comorbidity
  • Tongue piercing or other piercings in the mouth, including lips and cheek.
  • Participations with current or history of clinically significant medical disorder or condition
  • Subjects who are human immunodeficiency virus (HIV)-seropositive with a CD4+ count < 200 or active acquired immune deficiency syndrome (AIDS)
  • Participants who have any Class III or IV congestive heart failure, symptomatic myocardial ischemia, a history of long QT syndrome.
  • Participants who are currently taking Class 1A antiarrhythmic medications or Class III antiarrhythmic medications
  • Participants who have uncontrolled hypertension or clinically significant ECG abnormalities
  • Participants who have a pulse oximetry ≤93% at screening, due to any medical reason.
  • Subject has AST or ALT levels ≥3 X the upper limit of normal or total bilirubin or creatinine ≥1.5 X ULN, on the screening laboratory assessments
  • Participants with known significant liver disease.
  • Participants who take any medication, nutraceutical, herbal product with known CYP3A4 inhibition or induction properties within 14 days of screening.
  • Participants who are at suicidal risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848054

Locations
United States, Alabama
Birmingham, Alabama, United States
Haleyville, Alabama, United States
United States, California
National City, California, United States
Oceanside, California, United States
United States, Florida
Jacksonville, Florida, United States
Maitland, Florida, United States
North Miami, Florida, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Fall River, Massachusetts, United States
United States, Mississippi
Flowood, Mississippi, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Orexo AB
Worldwide Clinical Trials
Investigators
Principal Investigator: Lynn Webster Life Tree Pain Clinic, 3838 S 700 E Suite 200, Salt Lake City, UT 84106
  More Information

No publications provided

Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01848054     History of Changes
Other Study ID Numbers: OX219-007
Study First Received: May 2, 2013
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 21, 2014