Status:
COMPLETED
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
Lead Sponsor:
Orexo AB
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Opioid-Related Disorders
Opiate Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothes...
Detailed Description
This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled, non-inferiority study conducted at 13 sites within the US. Eligible patients participated in 8 treatment vi...
Eligibility Criteria
Inclusion
- 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 of age (inclusive)
- Met clinical criteria for opioid dependence in past 12 months based on DSM-IV-TR
- Provided buprenorphine-negative urine drug screen prior to randomization
- Provided negative urine pregnancy test
- Females of childbearing potential were required to be 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
- Participants receiving opioids for pain must receive clearance from their prescribing physician to be withdrawn from their prescribed opioids
- Generally good health as determined by the investigator
- Participants should demonstrate at least mild withdrawal symptoms (defined as a COWS score \>9 at Day 1 predose)
Exclusion
- Females who are pregnant or lactating, or planning to be pregnant during study
- Any previous prescribed treatment with buprenorphine monotherapy (e.g., generic buprenorphine sublingual tablets)
- Prescribed treatment with buprenorphine or naloxone 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 buprenorphine, naloxone, 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
- Participants with current or history of clinically significant medical disorder or condition
- Participants 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.
- Individuals with 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT01848054
Start Date
June 1 2013
End Date
January 1 2014
Last Update
May 10 2017
Active Locations (14)
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1
Birmingham, Alabama, United States
2
Haleyville, Alabama, United States
3
National City, California, United States
4
Oceanside, California, United States