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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)

Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
Craving [ Time Frame: Week 1 ]
The primary efficacy endpoint is the change in the "strength" of alcohol craving Visual Analog Scale (VAS) score minus the water craving VAS score during the alcohol cue reactivity session at Week 2 - after one week of investigational product treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HLAB-002 of ANS-6637 for Alcohol Use Disorder
Official Title  ICMJE Human Laboratory Study of ANS-6637 for Alcohol Use Disorder
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™).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • 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
  • Drug: Placebo oral tablet
    Placebo oral tablet
Study Arms  ICMJE
  • Active Comparator: ANS-6637 - 200mg
    200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
    Intervention: Drug: ANS-6637
  • Active Comparator: ANS-6637 - 600mg
    600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
    Intervention: Drug: ANS-6637
  • Placebo Comparator: Matched Placebo
    2 placebo tablets once a day
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970109
Other Study ID Numbers  ICMJE HLAB-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will be shared under a clinical trials agreement with Amygdala Neurosciences.
Responsible Party National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Raye Litten, PhD National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP