Astellas

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants with Opioid Use Disorder

This study is to test a new way to treat those who misuse opioids. The primary purpose of this study is to test the safety and side effects of ASP8062 when given with the Medication-Assisted Treatment (MAT) buprenorphine/naloxone to treat opioid misuse. MAT is the use of medications, in combination with counseling, to provide a “whole-patient” approach to treat substance use such as the misuse of opioids.

Trial ID: NCT05062577

Trial Details

This study lasts approximately 6 months and involves screening, study treatment, and follow-up periods. All study participants will receive buprenorphine/naloxone as standard of care MAT. In addition to receiving buprenorphine/naloxone, study participants will be randomly given either the study medication (ASP8062) or placebo (no active medication).

Estimated Enrollment

252 Participants

Phase

Eligibility Criteria

Participants must:

Be between 18 and 65 years of age
Be misusing opioids, as determined by the study doctor
Be seeking medical treatment for misuse of opioids
Be taking or willing to begin taking buprenorphine/naloxone for their condition
Have stable living conditions, as determined by the study doctor

Participants will meet with a study doctor to confirm their eligibility to take part in the study.

Participants must not:

Recently received any investigational drug
A history of decreased breaths while on medication for opioid misuse
HIV, positive hepatitis B surface antigen (HbsAg), or detectable hepatitis B
Chronic pain that is being treated with opioids other than buprenorphine or buprenorphine/naloxone
Moderate to severe substance use disorder on any other psychoactive substances (substances that cause changes in mood, behavior, awareness, etc.) other than opioids, caffeine or nicotine
Previous use of ASP8062
Certain medical conditions or test results that would exclude their participation in the study

Additional criteria may apply.

What Will Happen in This Study

Taking part in this study includes:

Screening to see if you are eligible for the study (from approximately 4 weeks or 28 days up to 8 weeks or 56 days)
Study Treatment with the study medication (ASP8062) or placebo (no active medication) in addition to treatment with buprenorphine/naloxone (12 weeks or 85 days)
Follow-up (4 weeks or 30 days after the last dose of ASP8062 or placebo)

Participants in this study will be randomly assigned (like the flip of a coin) to receive either the ASP8062 or placebo. All study participants will receive buprenorphine/naloxone in addition to ASP8062 or placebo.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Will I have to pay anything to be a part of this clinical trial?

You do not have to pay anything to be in the study. All study-related services are provided at no cost.

What is a placebo?

A placebo is a substance that looks like a drug or treatment but does not have an active ingredient in it.

This type of clinical trial is called a “double-blind study.” In a double-blind study, neither the participants nor the doctors know who is receiving ASP8062 or the placebo. Researchers use a placebo to make sure that any effects of a clinical trial treatment they find in the trial are actually caused by the treatment being studied.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of investigational products or treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the clinical trial.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, and phone number
Your ethnic origin
Medical information, including information from other hospitals/institutions, such as your physical health, mental health, and past treatments
Video files (you taking the study medication/placebo and buprenorphine/naloxone) and information from interviews and questionnaires
Test results and information from your samples
Other information you give to the study team, which may include limited financial information such as bank account routing information

Who has access to your personal information?

All of your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), research collaboration and licensing partners, service providers and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.