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

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696434
• Other study ID #: ALK6428-A302
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2019
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 30, 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Opioid Use Disorder

Intervention

Drug:
• Naltrexone
daily dosing
• Placebo
daily dosing
• Buprenorphine
daily dosing

Locations

Country	Name	City	State
United States	John Hopkins School of Medicine	Baltimore	Maryland
United States	Hassman Research Institute	Berlin	New Jersey
United States	Duke University Medical Center	Durham	North Carolina
United States	Segal Institute for Clinical Research	Lauderhill	Florida
United States	New York State Psychiatric Institute	New York	New York
United States	Research Centers of America, LLC	Oakland Park	Florida
United States	University of Pennsylvania Treatment Research Center	Philadelphia	Pennsylvania
United States	Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Neuroscience Research Institute, Inc.	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8	Demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS]	8 days
Secondary	Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection	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
Secondary	Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal	COWS score	Days 9-11
Secondary	Mean Peak COWS Scores During the Treatment Period (Days 1/1a-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).	Up to 7 days
Secondary	Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation 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.	The COWS was administered 4-6 times per day during the Treatment Period
Secondary	Mean Score for "Desire for Opioids" Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period	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."	Up to 11 days
Secondary	Incidence of Adverse Events (AEs)	Number and percentage of subjects who experienced AEs.	Up to 42 days