Status:
COMPLETED
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Lead Sponsor:
Orexo AB
Collaborating Sponsors:
Worldwide Clinical Trials
Conditions:
Opioid Dependence, on Agonist Therapy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX...
Detailed Description
This prospective, randomized, multicenter, parallel-group, non-inferiority study was conducted at 43 centers in the United States from August 2013 to April 2014. A non-inferior design was used because...
Eligibility Criteria
Inclusion
- Male/female 18-65 years old
- Able to read, comprehend \& sign the informed consent form
- Meet opioid dependence criteria in DSM-IV-TR the past 12 months
- Have a buprenorphine-negative UDS \&/or urine dipstick
- Prepared to abstain from opioids other than the study drug \& from other addictive drugs
- Negative urine pregnancy test
- Females of childbearing potential who use a reliable method of contraception. Females of non-childbearing potential; surgically sterile or post-menopausal as defined by being at least 50 years of age \& having an absence of menses for at least 2 years
- Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain
- Lack of clinically significant abnormalities in health assessments performed at screening. Unclear cases should be approved by the medical monitor
- At least mild withdrawal symptoms (COWS ≥9)
Exclusion
- Pregnant, lactating or planning to be pregnant during study
- Unwilling/unable to comply with the requirements of the protocol (e.g., pending incarceration) are in a situation/condition that may interfere with participation in the study
- Prescribed treatment with generic buprenorphine monotherapy within 90 days prior start of treatment
- Daily dose of methadone over 30 mg during the past week or who received the last dose of methadone less than 30 hours prior to treatment
- Participating in other clinical studies in which medications is delivered or who have used an investigational drug/device within the last 30 days
- Allergy, sensitivity or intolerance to BUP, NAL or any related drug; history of drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject/study
- Staff, affiliated with, or family member of the staff directly involved with this study
- Serious untreated Axis I DSM-IV-TR psychiatric comorbidity (actively suicidal or homicidal, have untreated schizophrenia)
- Tongue/oral deformities that may affect the absorption of the drug products
- Current/history of clinically significant medical disorder or condition which would jeopardize the safety or impact the validity of the results. Unclear cases should be discussed with \& approved by the medical monitor
- HIV-seropositive with a CD4+ count \<200, active AIDS defining infection in the last 120 days
- Have Class III/IV congestive heart failure, symptomatic myocardial ischemia or history of long QT syndrome (or an immediate family member with this condition)
- Currently taking Class 1A antiarrhythmic medications (e.g., quinidine, procainamide, \& disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, \& dofetilide)
- Have uncontrolled hypertension, pulse oximetry ≤92%or clinically significant abnormality on 12-lead ECG, including a corrected QT (QTc) interval \>450 ms
- Severe liver disease
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
759 Patients enrolled
Trial Details
Trial ID
NCT01908842
Start Date
August 1 2013
End Date
April 1 2014
Last Update
May 10 2017
Active Locations (36)
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1
Baldwin County, Alabama, United States
2
Houston County, Alabama, United States
3
Maricopa, Arizona, United States
4
Beverly Hills, California, United States