HLAB-002 of ANS-6637 for Alcohol Use Disorder

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT03970109

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

43

Starts

2019-10-08

Expected to finish

2020-05-22

Last updated by the study team

2024-10-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Agree (if male) to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of the first administration of the study drug until 7 days following the final administration of the study drug. One of the following acceptable methods of contraception must be utilized:
• Surgical sterilization (vasectomy);
• The participant's female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or sub dermal implants (commenced at least 14 days prior to study drug administration to the male participant)
• The participant's female partner uses a medically prescribed topically applied transdermal contraceptive patch (commenced at least 14 days prior to study drug administration to the male participant);
• The participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year);
• The participant's female partner has undergone placement of an intrauterine device or intrauterine system;
• True abstinence: when this is in line with the preferred and usual lifestyle of the participant.
• Agree (if male) to refrain from sperm donation from the randomization visit to at least 7 days after the last dose of study drug.
• Be able to take oral medication and be willing to adhere to the medication regimen.
• Complete all assessments required at screening and baseline.

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.
• Be mandated by the court to obtain treatment for alcohol-dependence, or has probation or parole requirements that might interfere with study participation.
• Be anyone who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification.
• Have undergone medical detoxification (e.g., reports using a benzodiazepine) during the screening phase (prior to randomization).
• Have been treated with a pharmacotherapy for alcohol use disorder within 6 months prior to randomization.
• Have any of the following, based on DSM-5 criteria as assessed using theMINI:
• Current or lifetime diagnosis of psychotic disorders,
• Current bipolar disorder,
• Current major depressive episode,
• Current (past 3 months) eating disorder (anorexia or bulimia), or
• Within past year diagnosis of panic disorder with or without agoraphobia. Note: Subjects diagnosed with psychiatric disorders not specifically excluded above could be included at the discretion of the PI as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity.

Where it is running

• Yale — New Haven, Connecticut, United States
• Brown University — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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