HLAB-002 of ANS-6637 for Alcohol Use Disorder

NCT03970109 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HLAB-002
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief Summary

Primary: The primary objective of this study was to evaluate the effects of 2 different doses of ANS-6637, 200 mg (given as 2 x 100 mg tablets) and 600 mg (given as 2 x 300 mg tablets) once a day, and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 1 week of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary: Secondary objectives included evaluation of ANS-6637 200 mg, ANS-6637 600 mg, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Conditions

Alcohol Use Disorder

Keywords

pharmacotherapy; human laboratory study; novel medication

Outcome Measures

Primary Outcomes (1)

• Craving - "How Strong is Your Craving to Drink Alcohol" Visual Analog Scale (VAS) Item

  The primary efficacy endpoint is the change in the "strength" of alcohol craving Visual Analog Scale (VAS) score for the question, "How strong is your craving to drink alcohol," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).

  Week 2

Secondary Outcomes (16)

• Number of Subjects With no Heavy Drinking Days

  Last 4 weeks of treatment, from Week 2 to Week 5

• Number of Subjects Abstinent From Alcohol

  Last 4 weeks of treatment, from Week 2 to Week 5

• WHO 1-level Decrease in Alcohol Consumption

  Last 4 weeks of treatment, from Week 2 to Week 5

• WHO 2-level Decrease in Alcohol Consumption

  Last 4 weeks of treatment, from Week 2 to Week 5

• Percentage of Days Abstinent

  Last 4 weeks of treatment, from Week 2 to Week 5

Study Arms (3)

ANS-6637 - 200mg

ACTIVE COMPARATOR

200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day

Drug: ANS-6637

ANS-6637 - 600mg

ACTIVE COMPARATOR

600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day

Drug: ANS-6637

Matched Placebo

PLACEBO COMPARATOR

2 placebo tablets once a day

Drug: Placebo oral tablet

Interventions

ANS-6637 DRUG

200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day

ANS-6637 - 200mg; ANS-6637 - 600mg

Placebo oral tablet DRUG

Placebo oral tablet

Matched Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 21 years of age.
• Meet the DSM-5 criteria for alcohol use disorder of at least moderate severity.
• If male, report drinking a weekly average of at least 35 drinks per week or if female report drinking a weekly average of at least 28 drinks per week for the 28-day period prior to consent.
• Have at least 1 heavy drinking day (4 or more drinks for women/5 or more drinks for men) during the 7-day period prior to randomization.
• Be seeking treatment for AUD and desire a reduction or cessation of drinking.
• Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
• Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control to at least 7 days post the last dose of study drug, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal (one year):
• oral contraceptives,
• contraceptive sponge,
• patch,
• double barrier (diaphragm/spermicidal or condom/spermicidal),
• intrauterine contraceptive system,
• etonogestrel implant,
• medroxyprogesterone acetate contraceptive injection,
• complete abstinence from sexual intercourse, and/or hormonal vaginal contraceptive ring.

You may not qualify if:

• Current (past 12 months) substance use disorder of at least moderate severity (4 or more criteria) for any psychoactive substance other than alcohol and nicotine, including sedatives and hypnotics, as defined by DSM-5 criteria.
• Urine drug test positive performed during screening or baseline for any of the following substances:
• benzodiazepines,
• cocaine,
• opioids,
• amphetamines,
• methamphetamine,
• buprenorphine,
• methadone,
• barbiturates,
• oxycodone,
• and/or MDMA. Note: Testing for THC was included in the urine drug test; however, subjects who tested positive for THC were still eligible to participate in the study unless they had moderate or greater severity for cannabis use disorder as indicated by DSM-5 criteria. The results for THC were recorded for information only. If positive for opioids or oxycodone but recent opiate use for acute pain was reported by the subject, then the subject could be included at the discretion of the investigator.
• VAS craving rating ("How strong is your craving to drink alcohol") during first presentation of alcohol cue \<5 during the screening cue reactivity session.
• Have been hospitalized for alcohol intoxication delirium, alcohol withdrawal delirium, alcohol-induced persisting dementia or amnestic disorder, or have had an alcohol withdrawal seizure, alcohol-induced psychotic disorder with a primary diagnosis of AUD or a history of any seizure disorder.
• Have participated in any behavioral and/or pharmacological intervention research study for the treatment of alcoholism where the last intervention was within 3 years prior to signing the informed consent.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (3)

Yale

New Haven, Connecticut, 06519, United States

Location

Brown University

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

ANS-6637

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Daniel Falk
• Organization: National Institutes of Health

falkde@mail.nih.gov

301-443-0788

Study Officials

• Raye Litten, PhD

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: This study is a 3-arm, double-blind, randomized, placebo-controlled, parallel group, 3-site study designed to assess the effects of ANS-6637 as compared with placebo on responses to in vivo alcohol cue exposure in the human laboratory setting.

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: October 8, 2019
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: October 29, 2024
• Results First Posted: March 10, 2022

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)