Phase 3
N=758
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Opioid Dependence, on Agonist Therapy
Bottom Line
View on ClinicalTrials.gov: NCT01908842 ↗Enrolled (actual)
758
Serious AEs
0.5%
Results posted
May 2015
Primary outcome: Primary: Primary Endpoints of Retention in Treatment at Days 3 and 15 — 309; 302; 273; 269 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BNX sublingual tablets (Drug); BNX sublingual film (Drug); Buprenorphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orexo AB
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Endpoints of Retention in Treatment at Days 3 and 15 |
309; 302; 273; 269 | — |
| SECONDARY Clinical Opiate Withdrawal Scale (COWS) Scores: Induction |
15.0; 14.9; 10.5; 10.3; 8.8; 8.3 | — |
| SECONDARY COWS Total Scores: Stabilization/Maintenance |
6.0; 5.9; 5.2; 5.1; 4.8; 4.6 | — |
| SECONDARY Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction |
31.7; 33.0; 22.7; 23.0; 19.1; 17.8 | — |
| SECONDARY SOWS Total Scores: Stabilization/Maintenance |
11.9; 12.6; 10.1; 10.2; 9.0; 8.8 | — |
| SECONDARY Visual Analog Scale (VAS) Cravings: Induction |
69.2; 71.9; 56.8; 58.2; 49.2; 48.8 | — |
| SECONDARY VAS Craving Scores: Stabilization/Maintenance |
33.7; 34.5; 29.1; 28.5; 26.2; 23.7 | — |
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 sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.
Eligibility Criteria
Inclusion Criteria
- 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- Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain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 Criteria
- 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 450 ms
- Severe liver disease
Data sourced from ClinicalTrials.gov (NCT01908842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.