HLAB-002 of ANS-6637 for Alcohol Use Disorder

• Status: Terminated
• Trial end date: 2020-07-02
• Target enrollment: 0
• Participant gender: All

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™).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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.