AzTrials
AzTrials

Opioid Use DisorderPhase 3NCT02696434

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

A Phase 3 study testing Naltrexone and Buprenorphine in people with Opioid Use Disorder, run by Alkermes, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Opioid Use Disorder
What is being tested?
Naltrexone and Buprenorphine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
9 sitesUnited States
Study dates
Apr 2016to 30 Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • John Hopkins School of Medicine

    Baltimore, Maryland, 21205-1911

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Segal Institute for Clinical Research

    Lauderhill, Florida, 33308

  • New York State Psychiatric Institute

    New York, New York, 10032

  • Research Centers of America, LLC

    Oakland Park, Florida, 33334

  • University of Pennsylvania Treatment Research Center

    Philadelphia, Pennsylvania, 19104

  • Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Neuroscience Research Institute, Inc.

    Winfield, Illinois, 60190

Other trials in United States

About this study

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

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.

Being tested
Naltrexone, Placebo, Buprenorphine
Keywords
naltrexone, VIVITROL, buprenorphine, opioid, addiction
Medical subject headings
Opioid-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NaltrexoneDrug

    daily dosing

  • PlaceboDrug

    daily dosing

  • BuprenorphineDrug

    daily dosing

Study groups in NCT02696434
Study groupRoleWhat they receive
PBO NTX + BUPActive comparatorPlacebo naltrexone + buprenorphine
Receives: Drug: Placebo; Drug: Buprenorphine
NTX + BUPExperimentalNaltrexone + buprenorphine
Receives: Drug: Naltrexone; Drug: Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8

    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).

    Measured: 8 days

Secondary outcomes (6)

  1. 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).

    Measured: 1 week

  2. Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal

    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).

    Measured: Days 9-11

  3. 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).

    Measured: Up to 7 days

  4. 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.

    Measured: The COWS was administered 4-6 times per day during the Treatment Period

  5. 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."

    Measured: Up to 11 days

  6. Incidence of Adverse Events (AEs)

    Number and percentage of subjects who experienced AEs.

    Measured: Up to 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionNov 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02696434
Sponsor's protocol ID
ALK6428-A302
Status last verified
Jan 2019
First submitted
26 Feb 2016
Last updated
12 Feb 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mannelli P, Douaihy AB, Akerman SC, Legedza A, Fratantonio J, Zavod A, Sullivan MA. Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting. Am J Addict. 2022 Mar;31(2):142-147. doi: 10.1111/ajad.13264. Epub 2022 Feb 9.

    PubMed 35137481

  • Mannelli 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.

    PubMed 34752714

  • Kosten T, Aharonovich E, Nangia N, Zavod A, Akerman SC, Lopez-Bresnahan M, Sullivan MA. Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial. Addict Behav. 2020 Dec;111:106538. doi: 10.1016/j.addbeh.2020.106538. Epub 2020 Jul 3.

    PubMed 32777606

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naltrexone and Buprenorphine in people with Opioid Use Disorder, run by Alkermes, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 (time frame: 8 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02696434, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in