Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder

NCT04169360 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HP-00088649
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a double blind, placebo controlled, randomized trial to evaluate the safety and preliminary efficacy of ANS-6637 in adults with opioid use disorder with and without opioid agonist therapy. Patients will be randomized to two arms: (1) ANS-6637 for three months vs (2) Placebo for three months. Subjects will subsequently be followed for an additional one month post treatment.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Grade 3-4 events, Grade 2 Significant event

  The number of Grade 3-4 adverse events, as defined by the Division of AIDS (DAIDS) Toxicity Table Version 2.1, July, 2017 as well as the number of Grade 2 events requiring medication interruption or deemed clinically significant by a study investigator

  16 weeks

Secondary Outcomes (4)

• Urine Drug Screen

  16 weeks

• Opioid Craving

  16 weeks

• Opioid Agonist Therapy (OAT) concentration

  16 weeks

• Self reported description of drug use (Self-reported frequency/quantity/mode of opioid use, self-reported use of other drugs, overdose and overdose death)

  16 weeks

Other Outcomes (4)

• Change in Darke HIV Risk Taking Behavior Survey Score

  16 weeks

• Change in HIV Test Result

  16 weeks

• Change in Hepatitis C (HCV) RNA result

  16 weeks

Study Arms (2)

ANS-6637

EXPERIMENTAL

ANS-6637 600mg once daily for 12 weeks

Drug: ANS-6637

Placebo arm

PLACEBO COMPARATOR

Placebo 600 mg once daily for 12 weeks

Drug: Placebo oral tablet

Interventions

ANS-6637 DRUG

White, oblong 300 mg tablet

ANS-6637

Placebo oral tablet DRUG

White, oblong 300 mg tablet

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have the ability to understand and must personally sign a written informed consent form, which must be obtained prior to initiation of study procedures.
• Must be between 18 and 65 years of age, inclusive.
• Must have the diagnosis of opioid use disorder by DSM (Diagnostic and Statistical Manual of Mental Disorders) V criteria of at least mild severity
• Must have a total score of 9 or greater (out of a total of 30) on the Opioid Craving Scale at screening
• If on opioid agonist therapy, must be on Opioid Agonist Therapy (OAT) medication for a minimum of six months prior to screening.
• If on medication for depression or anxiety, must be on a stable dose for a minimum of two months prior to screening.
• Must be able to take oral medication and be willing to adhere to the medication regimen
• Must agree to utilize the "AI Cure" platform, either on their personal phone or on a supplied device, for both daily video adherence monitoring as well as daily questionnaires for the entire study duration.
• Male subjects must refrain from sperm donation throughout the study period, and continuing for at least 90 days following the last dose of study drug.
• Subjects must refrain from blood donation throughout the study period, and continuing for at least 30 days following the last dose of study drug.
• Must be willing to comply with contraception guidelines: The fetal risks associated with ANS-6637 are not known, but pre-clinical animal data demonstrate some risk. Subjects must agree not to become pregnant or impregnate a female. Females of childbearing potential must have a pregnancy test at screening and baseline (Day 0). If pregnancy occurs or is suspected to occur, study staff must be notified immediately. For the duration of the study, subjects or female partners of childbearing potential must use one of the following, unless she is surgically sterile, post-menopausal, or partner is surgically sterile: oral contraceptives (OCP), contraceptive sponge, patch double barrier (diaphragm + spermicide or condom + spermicide), intrauterine device (IUD), etonogestrel implant, injection, hormonal vaginal contraceptive ring or complete abstinence
• Must be willing and able to comply with all study requirements and plan to attend all clinic visits.

You may not qualify if:

• A subject will be ineligible for this study if 1 or more of the following criteria are met:
• Clinically significant AND grade 2 or higher abnormal laboratory values at screening, as determined by principal investigator
• Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 2.5 x upper limit of normal or total bilirubin \> 1.6 x the upper limit of normal
• Creatinine clearance \< 60 mL/min/1.73m2 by Chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) Score.
• Personal or family history of Parkinson's Disease
• Diagnosed major depression AND with current self-reported depression episode
• Diagnosed generalized anxiety disorder AND with current self-reported uncontrolled anxiety
• Current self-reported suicidal ideation
• Diagnosed liver disease, including untreated chronic Hepatitis C (defined as detectable Hepatitis C RNA), Hepatitis B (defined as positive HBsAg), and/or cirrhosis (defined as Fibrosis (FIB)-4 \> 3.25 AND confirmed by Fibroscan or Fibrosure)
• Diagnosed Human Immunodeficiency Virus (HIV) AND detectable viral load \> 40 copies/mL
• Diagnosed moderate or serious dementia Taking any of the following medications in the last 6 months: dopamine agonist, dopamine antagonist, anti-psychotic, anti-convulsant (except for benzodiazepines and gabapentin) or barbiturate
• Inability to obtain venous access for sample collection.
• Had a prior history of any severe adverse reactions to ethanol \[e.g., flushing (noticeable redness of the neck or throat) and/or increased heart rate (subject reports sensation of increased heart rate or palpitations) after drinking alcohol\].
• Known hypersensitivity to formulation excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.
• Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to screening

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

ANS-6637

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sarah Kattakuzhy, MD

  Institute of Human Virology at the University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 19, 2019
• Study Start: January 1, 2021
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available at the time of publication or shortly thereafter, and will be kept indefinitely.
• Access Criteria: Will be determined by Principal Investigator