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Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

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ClinicalTrials.gov Identifier: NCT02696434
Recruitment Status : Completed
First Posted : March 2, 2016
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: Naltrexone Drug: Placebo Drug: Buprenorphine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Study Start Date : April 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PBO NTX + BUP
Placebo naltrexone + buprenorphine
Drug: Placebo
daily dosing

Drug: Buprenorphine
daily dosing

Experimental: NTX + BUP
Naltrexone + buprenorphine
Drug: Naltrexone
daily dosing

Drug: Buprenorphine
daily dosing




Primary Outcome Measures :
  1. Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 [ Time Frame: 8 days ]
    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).


Secondary Outcome Measures :
  1. Proportion of Days With COWS Peak Score </=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).

  2. Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal [ Time Frame: Days 9-11 ]
    COWS score </=12; 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).

  3. Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7) [ Time Frame: Up to 7 days ]
    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).

  4. Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period [ Time Frame: The COWS was administered 4-6 times per day during the Treatment Period ]
    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). The daily AUC COWS score is derived based on the actual time (unit in minutes) COWS administered on each day by using the linear trapezoidal rule, and then divided by the COWS administration duration (last COWS administration time minus first COWS administration time) for that day. The normalized AUC COWS score is the summation of daily AUC COWS score during the relevant period divided by the number of days with daily AUC COWS score.

  5. Mean Score for "Desire for Opioids" Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period [ Time Frame: Up to 11 days ]
    The Desire for Opioids 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."

  6. Incidence of Adverse Events (AEs) [ Time Frame: Up to 42 days ]
    Number and percentage of subjects who experienced AEs.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Willing and able to provide government-issued identification
  • Has a Body Mass Index (BMI) of 18.0-40.0 kg/m^2
  • Has a history of opioid use disorder diagnosis for at least 6 months
  • Has a history of prescribed buprenorphine (or buprenorphine/naloxone) maintenance for the prior 3 or more consecutive months and is currently buprenorphine-maintained
  • Must be voluntarily seeking treatment for opioid use disorder and be motivated to receive antagonist therapy
  • Willing 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 a positive urine drug screen for opiates or oxycodone at screening
  • Has used methadone within 30 days prior to study Day -5
  • Has used naltrexone (oral or VIVITROL) within the 90 days prior to Day -5
  • Has a history of seizures or has received anticonvulsant therapy within the past 5 years for treatment of seizures (use of anticonvulsant during the past detoxification is not exclusionary)
  • 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, VIVITROL, or naloxone
  • Additional criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696434


Locations
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United States, Florida
Segal Institute for Clinical Research
Lauderhill, Florida, United States, 33308
Research Centers of America, LLC
Oakland Park, Florida, United States, 33334
United States, Illinois
Neuroscience Research Institute, Inc.
Winfield, Illinois, United States, 60190
United States, Maryland
John Hopkins School of Medicine
Baltimore, Maryland, United States, 21205-1911
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Maria A. Sullivan, MD, PhD Alkermes, Inc.
  Study Documents (Full-Text)

Documents provided by Alkermes, Inc.:
Study Protocol  [PDF] June 14, 2017
Statistical Analysis Plan  [PDF] November 29, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02696434    
Other Study ID Numbers: ALK6428-A302
First Posted: March 2, 2016    Key Record Dates
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alkermes, Inc.:
naltrexone
VIVITROL
buprenorphine
opioid
addiction
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents