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Opioid Use DisorderPhase 2NCT05062577

A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder

A Phase 2 study testing ASP8062 and buprenorphine/naloxone in people with Opioid Use Disorder, run by Astellas Pharma Global Development, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Use Disorder
What is being tested?
ASP8062 and buprenorphine/naloxone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
8 Nov 2021to 28 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has a diagnosis of moderate or severe opioid use disorder (OUD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5) using the Mini International Neuropsychiatric Interview (MINI) version 7.02.
  • Participant is voluntarily seeking treatment for OUD, and is either:
  • Currently receiving medication-assisted treatment (MAT) (buprenorphine/naloxone maintenance dose equivalent to 16 mg/4 mg sublingual for >=28 days prior to screening) for OUD and considered clinically unstable, defined as: currently misusing opioids and has at least 4 positive urine drug screens during the Screening Period (including morphine and metabolites, diacetylmorphine [heroin], codeine, oxycodone, hydrocodone, hydromorphone, fentanyl and metabolites, meperidine, propoxyphene, tramadol, oxymorphone and methadone)
  • Is not currently receiving MAT for OUD, and has not received MAT (consistently for > 48 hours) within 60 days prior to screening, and is: willing to initiate buprenorphine/naloxone therapy; considered to be a good candidate for buprenorphine/naloxone treatment based on medical and psychosocial history; able to tolerate buprenorphine/naloxone at the required maintenance dose of 16 mg/4 mg during the 7 days prior to randomization; has a positive urine drug screen at the initial screening visit (Visit 1) (including morphine and metabolites, diacetylmorphine (heroin), codeine, oxycodone, hydrocodone, hydromorphone, fentanyl and metabolites, meperidine, propoxyphene, tramadol, oxymorphone and methadone).
  • Participant does not have on-going opioid withdrawal symptoms (a score of < 11 on the Clinical Opioid Withdrawal Scale (COWS)) at the time of randomization (Day 1).
  • Participant has a body mass index range of 18.5 to 45.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
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  • Participant has stable living conditions.
  • Participant agrees not to make significant changes to current non-medication therapy interventions (e.g., counseling, psychotherapy) in place at the time of Screening throughout the duration of the study.
  • Participant agrees not to participate in another interventional study while participating in the present study; defined as from the time of informed consent form (ICF) signature until completion of the last study visit.
  • Female participant is not pregnant and at least one of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP)
  • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final investigational product (IP) administration.
  • Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
  • Female participant must not donate ova starting at screening and throughout the study period and for 30 days after final IP administration.
  • Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 90 days after final IP administration.
  • Male participant must not donate sperm starting at screening and throughout the study period and for 90 days after final IP administration.
  • Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 90 days after final IP administration.

Who cannot join

  • Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant has a history of respiratory depression while on buprenorphine-based or other MAT for OUD.
  • Participant has human immunodeficiency virus (HIV) per screening serology test.
  • Participant has a positive hepatitis B surface antigen (HbsAg) or detectable hepatitis B DNA. Participants with negative HbsAg, positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antibody (anti-HBs) are eligible if hepatitis B DNA is undetectable.
  • Current diagnosis of chronic pain and currently treated with opioids other than buprenorphine or buprenorphine/naloxone.
  • Current DSM-5 diagnosis of moderate to severe substance use disorder on any other psychoactive substances other than opioids, caffeine or nicotine (e.g., alcohol, sedatives) and the non-opioid substance use disorder(s) are considered primary or coprimary, causing current (last 30 days) significant impairment and/or would interfere with the efficacy and safety assessments.
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  • Participant has 2 or more positive urine drug screen (UDS) results for barbiturates or benzodiazepines during screening. (Day 1 eligibility will be based on a quick urine test conducted on-site, and not a sample sent to the central lab.)
  • Participant has a known or suspected hypersensitivity to ASP8062, buprenorphine, naloxone or any components of the formulations used.
  • Participant has previous exposure to ASP8062.
  • Participant has a history of suicide attempt or suicidal behavior within 12 months prior to screening or has any suicidal ideation that meets criteria at a level of 4 or 5 by using the Columbia-Suicide Severity Rating Scale (C-SSRS) within 12 months prior to screening or who is at significant risk to commit suicide, as assessed at screening or at Day 1.
  • Participant's prescription for buprenorphine/naloxone is unable to be filled at the pharmacy during Screening because they are already receiving an opioid based MAT.
  • Participant has any clinically significant liver chemistry test result including aspartate aminotransferase [AST] or alanine aminotransferase [ALT] result > 3 times above the upper limit of normal (ULN), and total bilirubin [TBL] result > 1.5 times above the ULN at screening. These assessments may be repeated once, after a reasonable time period (but within the Screening Period).
  • Participant has a mean pulse < 45 or > 110 beats per minute (unless above the upper bound of the range [> 110 beats per minute] deemed to be secondary to opioid withdrawal); resting systolic blood pressure > 140 mmHg or < 90 mmHg, and/or a resting diastolic blood pressure > 90 mmHg at screening (unless out of range blood pressure is deemed to be secondary to opioid withdrawal). These assessments may be repeated once after a reasonable time period (but within the Screening Period).
  • Participant has a clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening or at randomization (Day 1). If the ECG is abnormal an additional ECG can be carried out. If this also gives a clinically significant abnormal result the participant must be excluded.
  • Participant has a history of chest pain or palpitation with either exertion or drug use, myocardial infarction, endocarditis (within 12 months of screening), unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease or a family history of Long QT Syndrome.
  • Participant has a clinically significant abnormality (e.g., severe respiratory insufficiency) in past medical history or at the screening visit that may place the participant at risk or interfere with the treatment outcomes.
  • Participant has a mean corrected QT interval using Fridericia's formula (QTcF) > 450 msec (for male participants) and > 470 msec (for female participants) at screening or at randomization. If the mean QTcF exceeds the limits above, one additional triplicate ECG can be taken on Day 1.
  • Participant has known kidney disease and a glomerular filtration rate (GFR) < 60 mL/min per meter squared at screening.
  • Participant has evidence of any clinically significant, uncontrolled cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary (including obstructive sleep apnea not controlled by a continuous positive airway pressure device), neurologic, dermatologic, psychiatric (other than moderate to severe OUD or other mild substance use disorders), renal and/or other major disease. Participants with mild, moderate or severe cocaine use disorder are not eligible.
  • Participant has planned surgery during the study participation.
  • Participant has an active malignancy or a history of malignancy (except for treated non melanoma skin cancer) within 5 years of screening.
  • Participant's treatment for OUD was required by a court order, or participant's current incarceration or pending incarceration/legal action that could prohibit participation or compliance in the study.
  • Participant is homeless or living in a shelter.
  • Participant has manic-depressive illness or Major Depressive Disorder with psychotic features.
  • Participant has clinically significant anemia or low hemoglobin (levels < 9 g/dL) at screening or donation of > 250 mL of blood or plasma within 30 days prior to providing informed consent.
  • Participant is currently using protocol-specified prohibited medications and is unable to wash out or adjust their dosage.
  • Participant has used any cytochrome P450 (CYP) 3A4 inhibitor (including most azole antifungals, macrolide antibiotics, protease inhibitors and antidepressants) or inducer (including phenobarbital, arbamazepine, phenytoin and rifampin) within 4 weeks prior to randomization.
  • Participant has a negative lab test for buprenorphine and norbuprenorphine during screening (at any time prior to Day 1) for participants currently receiving treatment with buprenorphine/naloxone, or during the Run-in Period for participants newly initiating buprenorphine/naloxone treatment. The Day 1 collection will not be included in the eligibility assessment for either participant group.
  • Participant has any condition which makes the participant unsuitable for study participation.
  • Participant is an employee of the Astellas Group, the clinical research organization (CRO) involved or the investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child or sibling, whether biological or legally adopted).
  • Participants with a positive urine drug screen for cocaine during Screening and/or a current diagnosis of mild, moderate or severe cocaine use disorder.

About this study

Official title: 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

The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.

Read the detailed description

The study will consist of the following periods: Screening Period (up to 56 days); Double-blind treatment period (12 weeks/ 85 days); a Buprenorphine/naloxone down-titration period (as determined by the participant in collaboration with the investigator) (14 days); and a Follow-up period (30 days post last dose ASP8062 or placebo ASP8062 for ASP8062 End of Treatment [EOT]).

Being tested
ASP8062, Placebo ASP8062, buprenorphine/naloxone
Keywords
ASP8062,, Opioid Use Disorder,, OUD,, Buprenorphine/Naloxone
Medical subject headings
Opioid-Related Disorders

What participants receive

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

  • ASP8062Drug

    oral

  • Placebo ASP8062Drug

    oral

  • buprenorphine/naloxoneDrug

    sublingual

Study groups in NCT05062577
Study groupRoleWhat they receive
ASP8062 in combination with buprenorphine/naloxoneExperimentalParticipants will receive ASP8062 once daily at bedtime (QHS) and buprenorphine/naloxone once daily every morning (QAM) for 12 weeks.
Receives: Drug: ASP8062; Drug: buprenorphine/naloxone
Placebo ASP8062 in combination with buprenorphine/naloxonePlacebo comparatorParticipants will receive matching placebo once daily at bedtime (QHS) and buprenorphine/naloxone once daily every morning (QAM) for 12 weeks.
Receives: Drug: Placebo ASP8062; Drug: buprenorphine/naloxone

What is being measured

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

  1. Percentage of participants with >= 80% of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use

    Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse.

    Percentage of participants with >= 80% of urine samples negative for misuse of opioid drugs combined with self reports negative for opioid use will be reported.

    Measured: Up to 12 weeks

  2. Number of participants with Adverse Events (AEs)

    Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study Investigational Product (IP) and other study treatments, whether or not considered related to the study IP and other study treatments. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study IP and other study treatments. This includes events related to the comparator and events related to the (study) procedures.

    An AE is considered "serious" if, the event: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important event.

    Measured: Up to 16 weeks

Secondary outcomes (9)

  1. The cumulative distribution function (CDF) of the percentage of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use

    Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse.

    The cumulative distribution function (CDF) of the percentage of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use will be reported.

    Measured: Up to 12 weeks

  2. Percentage of participants continuously abstinent from misuse of opioid drugs as assessed by urine samples and self-reports negative for opioid use

    Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse.

    Percentage of participants continuously abstinent from misuse of opioid drugs as assessed by urine samples and self-reports negative for opioid use will be reported.

    Measured: Up to 12 weeks

  3. Total number of visits of abstinence from misuse of opioid drugs as assessed by urine samples and self-reports negative for opioid use

    Participants will undergo weekly assessments for misuse of opioid drugs through urine drug screening in combination with self-reports of opioid drug misuse.

    Total number of visits of abstinence from misuse of opioid drugs will be reported.

    Measured: Up to 12 weeks

  4. Number of participants with vital sign abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values.

    Measured: Up to 16 weeks

  5. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values.

    Measured: Up to 16 weeks

  6. Change from baseline in blood oxygen saturation (SpO2)

    The blood oxygen saturation (SpO2) will be measured using a pulse oximeter placed on the participant's fingertip.

    Number of participants with low SpO2 levels will be reported.

    Measured: Baseline and up to 16 weeks

  7. Number of participants with Routine 12-lead electrocardiogram (ECG) abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant Routine 12-lead ECG values.

    Measured: Up to 16 weeks

  8. Number of participants with suicidal ideation and/or suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior.

    Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported.

    Measured: Up to 16 weeks

  9. Overall mortality (including opioid overdose mortality)

    The number of participants for overall mortality and mortality due to opioid overdose will be summarized by treatment group.

    Measured: Up to 16 weeks

Timeline

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

  1. First posted30 Sep 2021
  2. Study start8 Nov 2021
  3. Primary completion28 Feb 2023 (estimated)
  4. Study completion28 Feb 2023 (estimated)

Why it stopped: Due to corporate strategic considerations

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05062577
Sponsor's protocol ID
8062-CL-2221
Status last verified
Oct 2024
First submitted
21 Sep 2021
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP8062 and buprenorphine/naloxone in people with Opioid Use Disorder, run by Astellas Pharma Global Development, Inc..

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 17 inclusion and 31 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: withdrawn, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Percentage of participants with >= 80% of urine samples negative for misuse of opioid drugs combined with self-reports negative for opioid use (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05062577.

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 6 Nov 2024.

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