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HLAB-002 of ANS-6637 for Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970109
Recruitment Status : Suspended (Clinical Hold for Safety)
First Posted : May 31, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
The primary objective of this study is to evaluate the effects of two different doses of ANS-6637, 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) 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™).

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: ANS-6637 Drug: Placebo oral tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Human Laboratory Study of ANS-6637 for Alcohol Use Disorder
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: ANS-6637 - 200mg
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
Drug: ANS-6637
200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day

Active Comparator: ANS-6637 - 600mg
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
Drug: ANS-6637
200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day

Placebo Comparator: Matched Placebo
2 placebo tablets once a day
Drug: Placebo oral tablet
Placebo oral tablet




Primary Outcome Measures :
  1. Craving [ Time Frame: Week 2 ]
    The primary efficacy endpoint is the change in the "strength" of alcohol craving Visual Analog Scale (VAS) score in response to an alcohol cue minus the alcohol craving VAS score in response to a water cue during the alcohol cue reactivity session 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.


Secondary Outcome Measures :
  1. Percentage of subjects with no heavy drinking days [ Time Frame: Last 4 weeks of treatment ]
    Percent of subjects that have no heavy drinking days during the last 4 weeks of treatment. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.

  2. Percentage of subjects abstinent from alcohol [ Time Frame: Last 4 weeks of treatment ]
    Percent of subjects that have not drank alcohol during the last 4 weeks of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 21 years of age.
  • Meet the DSM-5 criteria for alcohol use disorder of a least moderate severity.
  • Be seeking treatment for AUD and desire a reduction or cessation of drinking.
  • 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):

    1. oral contraceptives,
    2. contraceptive sponge,
    3. patch,
    4. double barrier (diaphragm/spermicidal or condom/spermicidal),
    5. intrauterine contraceptive system,
    6. etonogestrel implant,
    7. medroxyprogesterone acetate contraceptive injection,
    8. 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:

    1. Surgical sterilization (vasectomy);
    2. 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)
    3. 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);
    4. The participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year);
    5. The participant's female partner has undergone placement of an intrauterine device or intrauterine system;
    6. True abstinence: when this is in line with the preferred and usual lifestyle of the participant.

Please contact clinical site for additional inclusion criteria.

Exclusion Criteria:

  • 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:

    1. benzodiazepines,
    2. cocaine,
    3. opioids,
    4. amphetamines,
    5. methamphetamine,
    6. buprenorphine,
    7. methadone,
    8. barbiturates,
    9. oxycodone,
    10. and/or 3,4-methylenedioxy-methamphetamine (MDMA).

Have any of the following, based on DSM-5 criteria as assessed using the MINI:

  1. Current or lifetime diagnosis of psychotic disorders,
  2. Current bipolar disorder,
  3. Current major depressive episode,
  4. Current (past 3 months) eating disorder (anorexia or bulimia), or
  5. Within past year diagnosis of panic disorder with or without agoraphobia.

    • Have moderate or serious dementia as assessed by clinical exam.
    • Be pregnant or breast-feeding or have plans to become pregnant at any time during the study or within 7 days after the last dose of investigational product.
    • Have clinically significant abnormal laboratory values, including elevation of liver enzymes (AST or ALT > 80 IU/mL).
    • Have abnormal calculated creatinine clearance defined as < 80 mL/min for subjects ≤ 55 years of age and < 65 mL/min for subjects > 55 years of age.
    • Have a serious or unstable medical illness or any potentially life-threatening or progressive medical condition other than addiction that may compromise subject safety or study conduct.
    • Have data suggesting cirrhosis of the liver (albumin < 3.2 g/dL, or ascites by physical exam).
    • Have been previously treated with ANS-6637 for any reason.
    • Have had gastric bypass surgery.
    • Have had a severe reaction to disulfiram while drinking alcohol requiring medical attention.

Please contact the clinical site for additional exclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970109


Locations
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United States, Connecticut
Yale
New Haven, Connecticut, United States, 06519
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Study Director: Raye Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT03970109    
Other Study ID Numbers: HLAB-002
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be shared under a clinical trials agreement with Amygdala Neurosciences.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders