Opioid-use DisorderPhase 2SEARCHNCT04169360
Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder
A Phase 2 study testing ANS-6637 in people with Opioid-use Disorder, run by University of Maryland, Baltimore.
Trial 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. 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?
- ANS-6637
- 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
- Jan 2021to 12 Jan 2021
- 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
- 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.
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- 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.
Who cannot join
- 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
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- 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
- Have any unresolved legal issues that could jeopardize continuation or completion of the study, at the discretion of the principal investigator
- Have any serious or active medical, surgical, or psychiatric conditions which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
- Are unable to comply with study requirements
About this study
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.
Read the detailed description
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. At screening, after providing consent, participants will be evaluated to ensure criteria for opioid use disorder by DSM V criteria is met, and whether the subject is receiving opioid agonist therapy will be determined. Participants will undergo a medical evaluation (including medical history, laboratory tests and EKG evaluation) to establish baseline medical and psychiatric diagnosis in order to ensure safety of participation. Once enrollment criteria are met, patients will be randomized in a blinded fashion to ANS-6637 or placebo, stratified by site and form of opioid agonist therapy. On Day 0, patients will be initiated on ANS-6637 vs. placebo according to randomization group. Subjects will be seen twice per week for two weeks, followed by weekly for two weeks, and then monthly for two months.
- Conditions
- Opioid-use Disorder
- Being tested
- ANS-6637, Placebo oral tablet
- 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.
ANS-6637Drug
White, oblong 300 mg tablet
Placebo oral tabletDrug
White, oblong 300 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| ANS-6637 | Experimental | ANS-6637 600mg once daily for 12 weeks Receives: Drug: ANS-6637 |
| Placebo arm | Placebo comparator | Placebo 600 mg once daily for 12 weeks Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (4)
Urine Drug Screen
Percentage opioid free period by urine drug screen
Measured: 16 weeks
Opioid Craving
Opioid craving will be assessed using the Opioid Craving scale questionnaire. The questionnaire consists of three questions and each of these questions has a minimum value of 0 and a maximum value 10. A score of 0 on each question is the best outcome; a score of 10 on each question is the worst outcome.
Measured: 16 weeks
Opioid Agonist Therapy (OAT) concentration
Serum concentration of buprenorphine or methadone
Measured: 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)
Self-reported frequency/quantity/mode of opioid use as well as self-reported use of other drugs will be gathered using the Drug Use Survey. Subjects will indicate frequency of opioid use by documenting the number of times they used an opioid during a given day. The quantity of opioids used will be determined by the dollar amount of opioids the subject reports they have consumed during that day. Subjects will also report mode of opioid use by indicating whether they are using opioids via injection, skin popping, snorting or oral. The Drug Use Survey will also ask subjects to report incidence of use of non-opioid substances. Incidence of overdose will be captured with the Naloxone questionnaire which asks, "since you last visit, have you experienced an overdose?". Incidence of overdose death will measured by the number of medical examiner confirmed deaths of study participants with cause of death listed as "overdose related to an opioid".
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study startJan 2021 (estimated)
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Why it stopped: The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences, the product company of ANS-6637, is no longer pursuing research with this compound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Kattakuzhy, University of Maryland, Baltimore
- Investigators
- Sarah Kattakuzhy, MD, Principal investigator, Institute of Human Virology at the University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169360
- Sponsor's protocol ID
- HP-00088649
- Acronym
- SEARCH
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator will share de-identified data with approved outside collaborators under appropriate agreements, at the time of publication or shortly thereafter.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of ANS-6637 to Reduce Drug Craving and Harm in People With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04169360
- Acronym / sponsor ID
- SEARCH / HP-00088649
- Conditions
- Opioid-use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The FDA determined that there is not adequate safety information to continue clinical investigations using ANS-6637 and Amygdala Neurosciences, the product company of ANS-6637, is no longer pursuing research with this compound.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. At screening, after providing consent, participants will be evaluated to ensure criteria for opioid use disorder by DSM V criteria is met, and whether the subject is receiving opioid agonist therapy will be determined. Participants will undergo a medical evaluation (including medical history, laboratory tests and EKG evaluation) to establish baseline medical and psychiatric diagnosis in order to ensure safety of participation. Once enrollment criteria are met, patients will be randomized in a blinded fashion to ANS-6637 or placebo, stratified by site and form of opioid agonist therapy. On Day 0, patients will be initiated on ANS-6637 vs. placebo according to randomization group. Subjects will be seen twice per week for two weeks, followed by weekly for two weeks, and then monthly for two months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANS-6637 | Experimental | Drug: ANS-6637ANS-6637 600mg once daily for 12 weeks |
| Placebo arm | Placebo comparator | Drug: Placebo oral tabletPlacebo 600 mg once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS-6637White, oblong 300 mg tablet | Drug | ANS-6637 |
| Placebo oral tabletWhite, oblong 300 mg tablet | Drug | Placebo arm |
Primary outcome
Number of Grade 3-4 events, Grade 2 Significant event
Time frame: 16 weeks
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
4 secondary outcomes
Urine Drug Screen
Time frame: 16 weeks
Opioid Craving
Time frame: 16 weeks
Opioid Agonist Therapy (OAT) concentration
Time frame: 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)
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Yes. The investigator will share de-identified data with approved outside collaborators under appropriate agreements, at the time of publication or shortly thereafter.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Kattakuzhy, MD principal investigator
Institute of Human Virology at the University of Maryland
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANS-6637 in people with Opioid-use Disorder, run by University of Maryland, Baltimore.
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 12 inclusion and 18 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 28 Jan 2021. 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?
Number of Grade 3-4 events, Grade 2 Significant event (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.