Alcohol Use DisorderPhase 2NCT04311294

Development of a Selective ALDH2 Inhibitor to Treat AUD

A Phase 2 study testing ANS-6637 Low Dose and ANS-6637 High Dose in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Alcohol Use Disorder
What is being tested?: ANS-6637 Low Dose and ANS-6637 High Dose
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: 1 siteUnited States
Study dates: Apr 2020to Mar 2022
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

21 years and older (adult, older adult);
meeet DSM-5 diagnostic criteria for alcohol use disorder (moderate or severe);
report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment.

Who cannot join

current treatment for alcohol problems;
a history of treatment for alcohol problems in the 30 days before enrollment;
currently seeking treatment for alcohol problems;
current DSM-5 diagnosis of dependence on any psychoactive substances other than alcohol or nicotine;
lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
positive urine screen for narcotics, amphetamines, or sedative hypnotics;

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serious alcohol withdrawal symptoms as indicated by a score of ≥10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
pregnant, nursing, or refusal to use reliable birth control method (if female);
medical condition that may interfere with safe study participation (e.g. unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
AST, ALT, or GGT ≥ 3 times upper limit of normal;
attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year;
currently on prescription medication that contraindicates use of ANS-6637;
other circumstances that, in the opinion of the investigators, compromises participant safety

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Addictions Lab
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Development of a Selective ALDH2 Inhibitor for the Treatment of Alcohol Use Disorder

Alcohol use disorder (AUD) represents a highly prevalent, costly, and often untreated condition in the United States. Pharmacotherapy offers a promising avenue for treating AUD and for improving clinical outcomes for this debilitating disorder. While developing novel medications to treat AUD remains a high priority research area, there are major opportunities to refine the process of screening novel compounds.

A promising novel pharmacology for AUD consists of the ANS-6637 compound which provides novel aldehyde dehydrogenase 2 (ALDH2) inhibition. Unlike disulfiram, a non-selective and irreversible ALDH2 and ALDH1 inhibitor, which produces an aversive flushing response, the oral ANS-6637 compound is a selective and reversible inhibitor of ALDH2 that attenuates the surge in dopamine (DA). Specifically, a preclinical study found that ANS-6637 blunted the surge of DA in ventral tegmental neurons without affecting the basal levels of DA in vivo in a rodent model of alcohol seeking behavior. In rodent models, selective and reversible ALDH2 inhibitors decrease alcohol seeking and taking, prevent operant self-administration, and block cue-induced reinstatement. These results suggest that ANS-6637 may be an effective treatment to reduce heavy drinking and suppress relapse in individuals with AUD.

This is a randomized, double-blind, placebo-controlled, dose response study of ANS-6637. A total of 75 men and women with current AUD will be randomly assigned to receive (a) ANS-6637 (200 mg), (b) ANS-6637 (600 mg), or (c) matched placebo for 7 days. On Day 4, participants will complete an fMRI task before and 45-minutes after a priming dose of alcohol (target Breath Alcohol Concentration (BrAC) of 0.03 g/dl). On Day 7 participants will return to the laboratory to complete an oral alcohol administration paradigm. The successful completion of this study will advance medications development for AUD by advancing the development of ANS-6637, a novel and promising compound for AUD.

Conditions: Alcohol Use Disorder
Being tested: ANS-6637 Low Dose, ANS-6637 High Dose, Matched Placebo
Keywords: Alcohol Use Disorder, Medications Development
Medical subject headings: Alcoholism

What participants receive

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

ANS-6637 Low DoseDrug
ANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.
ANS-6637 High DoseDrug
ANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.
Matched PlaceboDrug
ANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.

Study groups in NCT04311294
Study group	Role	What they receive
ANS-6637 Low Dose	Active comparator	200mg ANS-6637 (2 tablets) Receives: Drug: ANS-6637 Low Dose
ANS-6637 High Dose	Active comparator	600mg ANS-6637 (2 tablets) Receives: Drug: ANS-6637 High Dose
Placebo	Placebo comparator	0mg matched placebo (2 tablets) Receives: Drug: Matched Placebo

What is being measured

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

Change in Subjective Response to Alcohol
Participants will complete an oral alcohol challenge and will rate their subjective responses to alcohol at baseline (BrAC = 0.00 g/dl) and at 30, 45, 60, 120, and 180 minutes post alcohol. The primary outcome variables will be (a) alcohol craving, (b) stimulant/reward, and (c) sedative/aversive effects of alcohol.
Measured: Baseline, 30-, 45-, 60-, 120-, and 180-minutes post alcohol
Change in Neural Alcohol Cue Reactivity
Participants will complete a neuroimaging paradigm in which they view alcoholic and non-alcoholic beverage cues and will rate their subjective craving for alcohol. The primary outcome variable will be BOLD activation to alcohol cues in mesocorticolimbic reward circuitry.
Measured: Assessed on Day 4. Scan duration 1 hour.

Timeline

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

Apr 2020Mar 2022

First posted17 Mar 2020
Study startApr 2020 (estimated)
Primary completionJan 2022 (estimated)
Study completionMar 2022 (estimated)

Why it stopped: Project was not funded.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe 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
Model description: Randomized, triple-blind, placebo-controlled, parallel-group study of ANS-6637 (200mg, 600mg, 0mg \[palcebo\])
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04311294
Sponsor's protocol ID: 1R21AA028444
Status last verified: May 2021
First submitted: 11 Mar 2020
Last updated: 25 May 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: All data collected in this project will be shared (after appropriate de-identification) with the scientific community in a timely manner, in accordance with NIH Policy. Specifically, the dataset will be made available to the scientific community upon request and a data application will be required. These procedures are consistent with the recent NIAAA announcement: NOT-AA-18-010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Selective ALDH2 Inhibitor for the Treatment of Alcohol Use Disorder
ClinicalTrials.gov ID: NCT04311294
Acronym / sponsor ID: 1R21AA028444
Conditions: Alcohol Use Disorder
Keywords: Alcohol Use Disorder, Medications Development
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Project was not funded.
Enrolment: 0 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: Amygdala Neurosciences, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Apr 2020 (estimated)
Primary completion: Jan 2022 (estimated)
Study completion: Mar 2022 (estimated)
First posted: 17 Mar 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3
Model description: Randomized, triple-blind, placebo-controlled, parallel-group study of ANS-6637 (200mg, 600mg, 0mg [palcebo])

Arm	Type	Receives
ANS-6637 Low Dose	Active comparator	Drug: ANS-6637 Low Dose200mg ANS-6637 (2 tablets)
ANS-6637 High Dose	Active comparator	Drug: ANS-6637 High Dose600mg ANS-6637 (2 tablets)
Placebo	Placebo comparator	Drug: Matched Placebo0mg matched placebo (2 tablets)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

21 years and older (adult, older adult);
meeet DSM-5 diagnostic criteria for alcohol use disorder (moderate or severe);
report drinking at least 48 standard drinks in a 30-day period, during the 90 days before enrollment.

Key exclusion criteria (13 listed)

current treatment for alcohol problems;
a history of treatment for alcohol problems in the 30 days before enrollment;
currently seeking treatment for alcohol problems;
current DSM-5 diagnosis of dependence on any psychoactive substances other than alcohol or nicotine;
lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;

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-6637 Low DoseANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.	Drug	ANS-6637 Low Dose
ANS-6637 High DoseANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.	Drug	ANS-6637 High Dose
Matched PlaceboANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.	Drug	Placebo

Primary outcome

Change in Subjective Response to Alcohol
Time frame: Baseline, 30-, 45-, 60-, 120-, and 180-minutes post alcohol
Participants will complete an oral alcohol challenge and will rate their subjective responses to alcohol at baseline (BrAC = 0.00 g/dl) and at 30, 45, 60, 120, and 180 minutes post alcohol. The primary outcome variables will be (a) alcohol craving, (b) stimulant/reward, and (c) sedative/aversive effects of alcohol.
Change in Neural Alcohol Cue Reactivity
Time frame: Assessed on Day 4. Scan duration 1 hour.
Participants will complete a neuroimaging paradigm in which they view alcoholic and non-alcoholic beverage cues and will rate their subjective craving for alcohol. The primary outcome variable will be BOLD activation to alcohol cues in mesocorticolimbic reward circuitry.

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 25 May 2021.
Individual participant dataSharing planned: No. All data collected in this project will be shared (after appropriate de-identification) with the scientific community in a timely manner, in accordance with NIH Policy. Specifically, the dataset will be made available to the scientific community upon request and a data application will be required. These procedures are consistent with the recent NIAAA announcement: NOT-AA-18-010

Related trials for Alcohol Use Disorder

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SMART-r: Substance Monitoring and Active Relapse Tracking Repository
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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.

Lara Ray, PhD principal investigator

University of California, Los Angeles

Erica Grodin, PhD principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ANS-6637 Low Dose and ANS-6637 High Dose in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site 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 3 inclusion and 13 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Change in Subjective Response to Alcohol (time frame: Baseline, 30-, 45-, 60-, 120-, and 180-minutes post alcohol). 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 NCT04311294.

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 25 May 2021.