Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults

Completed · Phase 3

Conditions studied: Opioid Dependence, on Agonist Therapy

In brief

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 sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.

Key facts

Study ID

NCT01908842

Run by

Orexo AB

People needed

759

Starts

2013-08-01

Expected to finish

2014-04-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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• Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain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)

You may not qualify if…

• 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

Where it is running

• Study site — Baldwin County, Alabama, United States
• Study site — Houston County, Alabama, United States
• Study site — Maricopa, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Los Angeles County, California, United States
• Study site — Riverside County, California, United States
• Study site — San Diego County, California, United States
• Study site — Broward County, Florida, United States
• Study site — Colombia County, Florida, United States
• Study site — Duval County, Florida, United States
• Study site — Greater Metro Orlando, Florida, United States
• Study site — Lake County, Florida, United States
• Study site — Miami-Dade County, Florida, United States
• Study site — Osceola County, Florida, United States
• Study site — Palm Beach County, Florida, United States
• Study site — DeKalb County, Georgia, United States
• Study site — Chicagoland, Illinois, United States
• Study site — Johnson County, Kansas, United States
• Study site — Kenton County, Kentucky, United States
• Study site — Caddo Parish, Louisiana, United States
• Study site — Baltimore County, Maryland, United States
• Study site — Bristol County, Massachusetts, United States
• Study site — Saint Louis Metro Area, Missouri, United States
• Study site — Camden County, New Jersey, United States
• Study site — Warren County, New Jersey, United States

Full record on ClinicalTrials.gov

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