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

O

Orexo

Status and phase

Completed
Phase 3

Conditions

Opioid Dependence, on Agonist Therapy

Treatments

Drug: BNX sublingual film
Drug: Buprenorphine
Drug: BNX sublingual tablets

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01908842
OX219-006 Protocol Amendment 4

Details and patient eligibility

About

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.

Full 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 both products contain the same active components, and it was considered unethical to include a placebo arm. The study comprised an induction phase of 2 days and a stabilization phase of 20 days, with study visits scheduled on Days 1, 2, 3, 4, 8, 15, and 22. Eligible opioid-dependent patients were randomly assigned within 14 days of screening to induction with either the BNX sublingual tablets or generic buprenorphine tablets for 2 days. On Day 3, patients initially allocated to buprenorphine were switched to BNX film, whereas those allocated to BNX sublingual tablets continued on the same treatment. On Day 15, patients receiving BNX film were switched to BNX sublingual tablets, and those on BNX sublingual tablets were switched to BNX film. At the final study visit on Day 22, patients were offered the option of continuing in an open-label follow-up study of BNX sublingual tablets.

Enrollment

759 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male/female 18-65 years old
  2. Able to read, comprehend & sign the informed consent form
  3. Meet opioid dependence criteria in DSM-IV-TR the past 12 months
  4. Have a buprenorphine-negative UDS &/or urine dipstick
  5. Prepared to abstain from opioids other than the study drug & from other addictive drugs
  6. Negative urine pregnancy test
  7. 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
  8. Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain
  9. Lack of clinically significant abnormalities in health assessments performed at screening. Unclear cases should be approved by the medical monitor
  10. At least mild withdrawal symptoms (COWS ≥9)

Exclusion criteria

  1. Pregnant, lactating or planning to be pregnant during study
  2. 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
  3. Prescribed treatment with generic buprenorphine monotherapy within 90 days prior start of treatment
  4. 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
  5. Participating in other clinical studies in which medications is delivered or who have used an investigational drug/device within the last 30 days
  6. 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
  7. Staff, affiliated with, or family member of the staff directly involved with this study
  8. Serious untreated Axis I DSM-IV-TR psychiatric comorbidity (actively suicidal or homicidal, have untreated schizophrenia)
  9. Tongue/oral deformities that may affect the absorption of the drug products
  10. 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
  11. HIV-seropositive with a CD4+ count <200, active AIDS defining infection in the last 120 days
  12. Have Class III/IV congestive heart failure, symptomatic myocardial ischemia or history of long QT syndrome (or an immediate family member with this condition)
  13. Currently taking Class 1A antiarrhythmic medications (e.g., quinidine, procainamide, & disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, & dofetilide)
  14. Have uncontrolled hypertension, pulse oximetry ≤92%or clinically significant abnormality on 12-lead ECG, including a corrected QT (QTc) interval >450 ms
  15. Severe liver disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

759 participants in 2 patient groups

Buprenorphine; then OL BNX film, then BNX tablets
Active Comparator group
Description:
Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: Buprenorphine/naloxone sublingual film (open-label); Days 15-21: BNX sublingual tablets (open-label); Day 22: Offered option in continuing in open-label follow-up study of BNX sublingual tablets
Treatment:
Drug: BNX sublingual tablets
Drug: Buprenorphine
Drug: BNX sublingual film
BNX tablets, then OL BNX tablets, then BNX film
Experimental group
Description:
Days 1-2: BNX sublingual tablets (blinded); Days 3 to 14: BNX sublingual tablets (open-label); Days 15-21: Buprenorphine/naloxone sublingual film (open-label); Day 22: Offered option in continuing in open-label follow-up study of BNX sublingual tablets
Treatment:
Drug: BNX sublingual tablets
Drug: BNX sublingual film

Trial contacts and locations

36

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Data sourced from clinicaltrials.gov

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