Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
ISTART
Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments
1 other identifier
interventional
759
1 country
36
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 sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2013
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
May 22, 2015
CompletedMay 10, 2017
April 1, 2017
8 months
July 19, 2013
April 8, 2015
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoints of Retention in Treatment at Days 3 and 15
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.
Day 3 and Day 15
Secondary Outcomes (6)
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Days 1 and 2
COWS Total Scores: Stabilization/Maintenance
Days 3 through 22
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Days 1 and 2
SOWS Total Scores: Stabilization/Maintenance
Days 3 through 22
Visual Analog Scale (VAS) Cravings: Induction
Days 1 and 2
- +1 more secondary outcomes
Study Arms (2)
Buprenorphine; then OL BNX film, then BNX tablets
ACTIVE COMPARATORDays 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
BNX tablets, then OL BNX tablets, then BNX film
EXPERIMENTALDays 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
Interventions
Buprenorphine/naloxone sublingual tablets
Buprenorphine/naloxone sublingual film
Buprenorphine sublingual tablets
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orexo ABlead
- Worldwide Clinical Trialscollaborator
Study Sites (36)
Unknown Facility
Baldwin County, Alabama, United States
Unknown Facility
Houston County, Alabama, United States
Unknown Facility
Maricopa, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Los Angeles County, California, United States
Unknown Facility
Riverside County, California, United States
Unknown Facility
San Diego County, California, United States
Unknown Facility
Broward County, Florida, United States
Unknown Facility
Colombia County, Florida, United States
Unknown Facility
Duval County, Florida, United States
Unknown Facility
Greater Metro Orlando, Florida, United States
Unknown Facility
Lake County, Florida, United States
Unknown Facility
Miami-Dade County, Florida, United States
Unknown Facility
Osceola County, Florida, United States
Unknown Facility
Palm Beach County, Florida, United States
Unknown Facility
DeKalb County, Georgia, United States
Unknown Facility
Chicagoland, Illinois, United States
Unknown Facility
Johnson County, Kansas, United States
Unknown Facility
Kenton County, Kentucky, United States
Unknown Facility
Caddo Parish, Louisiana, United States
Unknown Facility
Baltimore County, Maryland, United States
Unknown Facility
Bristol County, Massachusetts, United States
Unknown Facility
Saint Louis Metro Area, Missouri, United States
Unknown Facility
Camden County, New Jersey, United States
Unknown Facility
Warren County, New Jersey, United States
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Warren County, Ohio, United States
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Oklahoma County, Oklahoma, United States
Unknown Facility
Portland Metropolitan Area, Oregon, United States
Unknown Facility
Allegheny County, Pennsylvania, United States
Unknown Facility
Delaware County, Pennsylvania, United States
Unknown Facility
Philadelphia County, Pennsylvania, United States
Unknown Facility
Charleston County, South Carolina, United States
Unknown Facility
Dallas County, Texas, United States
Unknown Facility
Salt Lake County, Utah, United States
Unknown Facility
Charlottesville Metropolitan Area, Virginia, United States
Unknown Facility
Benton County, Washington, United States
Related Publications (1)
Gunderson EW, Hjelmstrom P, Sumner M; 006 Study Investigators. Effects of a higher-bioavailability buprenorphine/naloxone sublingual tablet versus buprenorphine/naloxone film for the treatment of opioid dependence during induction and stabilization: a multicenter, randomized trial. Clin Ther. 2015 Oct 1;37(10):2244-55. doi: 10.1016/j.clinthera.2015.08.025. Epub 2015 Sep 26.
PMID: 26412801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Erik Gunderson, MD, FASAM
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Gunderson
University of Virginia, PO Box 800623, Charlottesville, VA 22911
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2013
First Posted
July 26, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 10, 2017
Results First Posted
May 22, 2015
Record last verified: 2017-04