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)

March 1, 2019 updated by: Alkermes, Inc.

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oceanside, California, United States, 92056
        • North Country Clinical Research
      • Orange, California, United States, 92868
        • NRC Research Institute
    • Florida
      • Lauderhill, Florida, United States, 33308
        • Atlantic Shores Hospital
      • Maitland, Florida, United States, 84107
        • Try Research
      • Oakland Park, Florida, United States, 33334
        • Research Centers of America
      • Orlando, Florida, United States, 32801
        • CNS Healthcare
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Neuroscience Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • John Hopkins University School of Medicine
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
      • Marlton, New Jersey, United States, 08053
        • PRA Health Sciences
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute/ Columbia University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania - Treatment Research Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic of UPMC
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 32751
        • Pharmaceutical Research Associates Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NTX/BUP
Oral naltrexone + sublingual buprenorphine
Drug: NTX/BUP
Daily doses
Active Comparator: NTX/PBO-B
Oral naltrexone + sublingual placebo
Drug: NTX/PBO-B
Daily doses
Placebo Comparator: PBO-N/PBO-B
Oral placebo naltrexone + sublingual placebo buprenorphine
Drug: PBO-N/PBO-B
Daily doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection
Time Frame: 1 week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection
Time Frame: 1 week
The Clinical Opiate Withdrawal Scale (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.
1 week
Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection
Time Frame: 1 week
The Clinical Opiate Withdrawal Scale (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.
1 week
Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection
Time Frame: The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7)
The Clinical Opiate Withdrawal Scale (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. To determine the daily AUC COWS score, a curve was generated by plotting the COWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC COWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC COWS score was then divided by the number of days with daily AUC COWS score during the treatment period. The AUC COWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time.
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
Time Frame: 1 week
The Desire for Opioids Visual Analog Scale (VAS) uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing "no desire for opioids" and 100 anchored on the right representing "strongest imaginable desire for opioids". Subjects placed a vertical line on the scale to indicate their desire for opioids at that particular time.
1 week
Incidence of Adverse Effects
Time Frame: Up to 92 days
The number of subjects who experienced treatment-emergent Adverse Events.
Up to 92 days
Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection
Time Frame: The SOWS was administered 4-6 times per day during the Treatment Period
The Subjective Opiate Withdrawal Scale (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). To determine the daily AUC SOWS score, a curve was generated by plotting the SOWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC SOWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC SOWS score was then divided by the number of days with daily AUC SOWS score during the treatment period. The AUC SOWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time.
The SOWS was administered 4-6 times per day during the Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Maria A. Sullivan, MD, PhD, Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

October 27, 2016

Study Completion (Actual)

January 9, 2017

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK6428-A301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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