Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
A Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL®
1 other identifier
interventional
380
1 country
20
Brief Summary
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2015
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2017
CompletedResults Posted
Study results publicly available
January 9, 2019
CompletedMarch 6, 2019
March 1, 2019
1.2 years
August 31, 2015
October 31, 2018
March 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection
Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).
1 week
Secondary Outcomes (6)
Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection
1 week
Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection
1 week
Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection
The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7)
Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection
1 week
Incidence of Adverse Effects
Up to 92 days
- +1 more secondary outcomes
Study Arms (3)
NTX/BUP
EXPERIMENTALOral naltrexone + sublingual buprenorphine
NTX/PBO-B
ACTIVE COMPARATOROral naltrexone + sublingual placebo
PBO-N/PBO-B
PLACEBO COMPARATOROral placebo naltrexone + sublingual placebo buprenorphine
Interventions
Eligibility Criteria
You may qualify if:
- Willing and able to provide informed consent
- Willing and able to provide government-issued identification
- Has a BMI of 18.0-40.0 kg/m\^2
- Has a physiologic dependence on opioids
- Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
- Wiling to abide by the contraception requirements for the duration of the study
- Additional criteria may apply
You may not qualify if:
- Is pregnant, planning to become pregnant or breastfeeding during the study
- Has used Buprenorphine within 7 days prior to randomization
- Has used Methadone within 14 days prior to randomization
- Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
- Has a history of seizures or has received anticonvulsant therapy within the past 5 years
- Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
- Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
- Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
- Has a history of hypersensitivity or adverse reaction to Buprenorphine, Naltrexone, or Naloxone
- Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
- Has significant suicidal ideation or behavior within the past year
- Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
- Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
- Is court mandated to receive treatment for opioid use disorder
- Additional criteria may apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (20)
North Country Clinical Research
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
Atlantic Shores Hospital
Lauderhill, Florida, 33308, United States
TRY Research
Maitland, Florida, 84107, United States
Research Centers of America
Oakland Park, Florida, 33334, United States
CNS Healthcare
Orlando, Florida, 32801, United States
Neuroscience Research Institute
Winfield, Illinois, 60190, United States
John Hopkins University School of Medicine
Baltimore, Maryland, 21224, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
PRA Health Sciences
Marlton, New Jersey, 08053, United States
New York State Psychiatric Institute/ Columbia University
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417, United States
University Of Pennsylvania - Treatment Research Center
Philadelphia, Pennsylvania, 19104, United States
Western Psychiatric Institute and Clinic of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
Insite Clinical Research
DeSoto, Texas, 75115, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Pharmaceutical Research Associates Inc.
Salt Lake City, Utah, 32751, United States
Related Publications (2)
Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial. Drug Alcohol Depend. 2018 Jun 1;187:171-178. doi: 10.1016/j.drugalcdep.2018.02.023. Epub 2018 Apr 10.
PMID: 29674251RESULTMannelli P, Douaihy AB, Zavod A, Legedza A, Akerman SC, Sullivan MA. Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone. Am J Drug Alcohol Abuse. 2021 Nov 2;47(6):753-759. doi: 10.1080/00952990.2021.1969659. Epub 2021 Nov 9.
PMID: 34752714DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eva Stroynowski
- Organization
- Alkermes
Study Officials
- STUDY DIRECTOR
Maria A. Sullivan, MD, PhD
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 1, 2015
Study Start
August 1, 2015
Primary Completion
October 27, 2016
Study Completion
January 9, 2017
Last Updated
March 6, 2019
Results First Posted
January 9, 2019
Record last verified: 2019-03