Alcohol AbusePhase 2NCT06710431
A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder
A Phase 2 study testing AFA-281 in people with Alcohol Abuse and Alcohol Abuse/addiction, run by Afasci Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Abuse, Alcohol Abuse/addiction, Anxiety
- What is being tested?
- AFA-281
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
- Liver enzymes AST, ALT, or GGT ≥ 3 times upper normal limit.
- Positive urine drug screen for drugs of abuse at Screening or Day -1.
- Receipt of any drug by injection within 30 days prior to study drug administration.
- A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
- Pregnant or nursing women.
- Receipt of any investigational products within 6 weeks prior to study drug administration.
- Current enrollment in another clinical study.
- Previous enrollment in this study.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to participate in the AFA-281 Phase I1a Study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California
Los Angeles, California, 90095
Lara Ray, MD, 310-319-4700, lararay@psych.ucla.edu
About this study
Official title: A Double-blind, Placebo-controlled, Phase IIA Human Laboratory Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder
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.
Read the detailed description
This study will determine the safety, tolerability, and exploratory efficacy of AFA-281. This study is a randomized, double-blind, placebo-controlled, human laboratory study of 36 community-based, non-treatment-seeking male and female individuals with current (i.e., past month) moderate-to-severe AUD (DSM-5). This study will be conducted by Dr. Lara Ray at UCLA. The total study duration is approximately 42 days including a 2-week screening period. Eligible participants will be randomized into one of three cohorts: 60 mg AFA-281, 120 mg AFA-281, or Placebo. Participants will start at a lower dose and increase the dose over 2 weeks then continue to maintain the dose for an additional 2 weeks. In week 4, participants will complete 7 daily visits to complete assessments and questionnaires.
- Conditions
- Alcohol Abuse, Alcohol Abuse/addiction, Anxiety, Pain Threshold, Depression Disorders, Sleep Disorder
- Being tested
- AFA-281
- Keywords
- AFA-281, alcohol abuse, alcohol, depression, pain threshold, sleep disorder, anxiety
- Medical subject headings
- Alcoholism, Behavior, Addictive, Anxiety Disorders, Sleep Wake Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFA-281Drug
AFA-281
| Study group | Role | What they receive |
|---|---|---|
| AFA-281 placebo control | Placebo comparator | AFA-281 placebo control group Receives: Drug: AFA-281 |
| Low dose of AFA-281 | Active comparator | AFA-281 at 60 mg per day Receives: Drug: AFA-281 |
| High dose AFA-281 | Active comparator | AFA-281 at 120 mg per day Receives: Drug: AFA-281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-induced alcohol craving
Questionnaire measures the level of alcohol craving
Measured: predose and weekly through Week 4
Stress-induced alcohol craving
Alcohol urge questionnaire after stressful stimuli
Measured: predose and weekly through Week 4
Subjective response to alcohol
Biphasic alcohol effects scale and profile of negative mood states
Measured: predose and weekly through Week 4
Pain assessments
Latency to first feel pain and pain intensity scoring using the McGill Pain Questionnaire
Measured: predose and weekly through Week 4
Safety and tolerability assessment
Daily questions via CAROMA system
Measured: Predose and Daily
Secondary outcomes (1)
Daily diary report
Examination of clinically relevant phenotypes by daily diary reports of alcohol use, alcohol craving, anxiety, depression, subjective pain and sleep
Measured: predose and weekly through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afasci Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lara Ray, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710431
- Sponsor's protocol ID
- AFA-281-304
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Phase IIA Human Laboratory Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06710431
- Acronym / sponsor ID
- AFA-281-304
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Afasci IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will determine the safety, tolerability, and exploratory efficacy of AFA-281. This study is a randomized, double-blind, placebo-controlled, human laboratory study of 36 community-based, non-treatment-seeking male and female individuals with current (i.e., past month) moderate-to-severe AUD (DSM-5). This study will be conducted by Dr. Lara Ray at UCLA. The total study duration is approximately 42 days including a 2-week screening period. Eligible participants will be randomized into one of three cohorts: 60 mg AFA-281, 120 mg AFA-281, or Placebo. Participants will start at a lower dose and increase the dose over 2 weeks then continue to maintain the dose for an additional 2 weeks. In week 4, participants will complete 7 daily visits to complete assessments and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AFA-281 placebo control | Placebo comparator | Drug: AFA-281AFA-281 placebo control group |
| Low dose of AFA-281 | Active comparator | Drug: AFA-281AFA-281 at 60 mg per day |
| High dose AFA-281 | Active comparator | Drug: AFA-281AFA-281 at 120 mg per day |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFA-281AFA-281 | Drug | AFA-281 placebo control, High dose AFA-281, Low dose of AFA-281 |
Primary outcome
Cue-induced alcohol craving
Time frame: predose and weekly through Week 4
Questionnaire measures the level of alcohol craving
Stress-induced alcohol craving
Time frame: predose and weekly through Week 4
Alcohol urge questionnaire after stressful stimuli
Subjective response to alcohol
Time frame: predose and weekly through Week 4
Biphasic alcohol effects scale and profile of negative mood states
Pain assessments
Time frame: predose and weekly through Week 4
Latency to first feel pain and pain intensity scoring using the McGill Pain Questionnaire
Safety and tolerability assessment
Time frame: Predose and Daily
Daily questions via CAROMA system
1 secondary outcome
Daily diary report
Time frame: predose and weekly through Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lara Ray, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFA-281 in people with Alcohol Abuse and Alcohol Abuse/addiction, run by Afasci Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Xie, MD (650-995-7320, simonxie@afasci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cue-induced alcohol craving (time frame: predose and weekly through Week 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.