A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder

NCT06710431 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AFA-281-304
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.

Conditions

Alcohol Abuse; Alcohol Abuse/addiction; Anxiety; Pain Threshold; Depression Disorders; Sleep Disorder

Keywords

AFA-281; alcohol abuse; alcohol; depression; pain threshold; sleep disorder; anxiety

Outcome Measures

Primary Outcomes (5)

• Cue-induced alcohol craving

  Questionnaire measures the level of alcohol craving

  predose and weekly through Week 4

• Stress-induced alcohol craving

  Alcohol urge questionnaire after stressful stimuli

  predose and weekly through Week 4

• Subjective response to alcohol

  Biphasic alcohol effects scale and profile of negative mood states

  predose and weekly through Week 4

• Pain assessments

  Latency to first feel pain and pain intensity scoring using the McGill Pain Questionnaire

  predose and weekly through Week 4

• Safety and tolerability assessment

  Daily questions via CAROMA system

  Predose and Daily

Secondary Outcomes (1)

• Daily diary report

  predose and weekly through Week 4

Study Arms (3)

AFA-281 placebo control

PLACEBO COMPARATOR

AFA-281 placebo control group

Drug: AFA-281

Low dose of AFA-281

ACTIVE COMPARATOR

AFA-281 at 60 mg per day

Drug: AFA-281

High dose AFA-281

ACTIVE COMPARATOR

AFA-281 at 120 mg per day

Drug: AFA-281

Interventions

AFA-281 DRUG

AFA-281

AFA-281 placebo control; High dose AFA-281; Low dose of AFA-281

Eligibility Criteria

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

You may qualify if:

• Age between 21 and 65
• Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
• Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for moderate or severe AUD
• Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent.
• Must be surgically sterile (vasectomy, tubal ligation, or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm for 90 days after study drug administration.

You may not qualify if:

• Current treatment for alcohol use or a history of treatment in the 30 days before enrollment or treatment seeking
• Current (last 12 months) DSM-5 diagnosis of dependence on any psychoactive substances other than nicotine
• Current DSM-5 diagnosis of substance use disorder for any substance other than alcohol and nicotine
• Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
• Current DSM-5 major depressive disorder with suicidal ideation
• Positive urine screen for narcotics, amphetamines, or sedative hypnotics
• Clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
• Pregnancy, nursing, or refusal to use reliable method of birth control if female
• History of significant sensitivity to any drug.
• Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) \> 430 ms.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.
• Has an estimated creatinine clearance (CrCl) outside of normal range.
• History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
• History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
• Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.

Sponsors & Collaborators

• Afasci Inc: lead

Study Sites (1)

University of California

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive; Anxiety Disorders; Sleep Wake Disorders; Depression

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms

Study Officials

• Lara Ray, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Xie, MD

CONTACT

650-995-7320; simonxie@afasci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

US (1)