Alcohol Use DisorderEarly Phase 1NCT05305404
Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving
A Early Phase 1 study testing Dexamethasone Oral in people with Alcohol Use Disorder, run by Stony Brook University at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 30 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-treatment seeking heavy drinking men and women with AUD
- Age range 18-55,
- Body Mass Index (BMI) of 18-35
- Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
- Able to provide informed written and verbal consent
- Able to read English and complete study evaluations
- Good health as verified by screening examination.
Who cannot join
- Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
- Unable to remain abstinent for five days
- Need for a medically assisted detoxification
- Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
- Psychotic or severely psychiatrically disabled
- Significant underlying medical conditions which would be of potential harm
Show all 9Show fewer
- Pregnancy or breast feeding women;
- Women using monophasic contraceptives
- Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of >450 msec for men and QTc>470 msec for women).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Health Sciences Center
Stony Brook, New York, 11794
About this study
Official title: Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)
This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.
- Conditions
- Alcohol Use Disorder
- Being tested
- Dexamethasone Oral, Placebo
- Keywords
- Stress, Dexamethasone, Immune system, Cortisol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
Also called Decadron, Dexamethasone Intensol, Dexasone, Solurex, and Baycadron.
1.5mg oral dexamethasone to be administered once at 11:00PM
PlaceboDrug
oral placebo to be administered once at 11:00PM
| Study group | Role | What they receive |
|---|---|---|
| Guanfacine | Active comparator | single dose of dexamethasone (1.5mg) administered orally Receives: Drug: Dexamethasone Oral |
| Placebo | Placebo comparator | single dose of placebo administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol craving as assessed using subjective report following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Measured: Change from baseline to +5 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Measured: Change from baseline to +15 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Measured: Change from baseline to +30 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Measured: Change from baseline to +5 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Measured: Change from baseline to +15 minutes following stress exposure
Alcohol craving as assessed using subjective report following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Measured: Change from baseline to +30 minutes following stress exposure
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
4mls of plasma ACTH will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
4mls of plasma ACTH will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
HPA axis response to stress exposure as assessed by ACTH
4mls of plasma ACTH will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-10 will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-10 will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL1-ra will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL1-ra will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFa will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFa will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress
Measured: Change from baseline to +5 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFR1 will be collected following exposure to stress
Measured: Change from baseline to +15 minutes following stress exposure
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFR1 will be collected following exposure to stress
Measured: Change from baseline to +30 minutes following stress exposure
Secondary outcomes (6)
Anxiety as assessed using subjective report following stress exposure
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Measured: Change from baseline to +5 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Measured: Change from baseline to +15 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Measured: Change from baseline to +30 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Measured: Change from baseline to +5 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Measured: Change from baseline to +15 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Measured: Change from baseline to +30 minutes following stress exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Mar 2022
- Primary completion23 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Fox, Stony Brook University
- Investigators
- Helen C Fox, PhD, Principal investigator, Indiana University School of Medicine, Dept. of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305404
- Sponsor's protocol ID
- R21AA029735
- Status last verified
- Sep 2026
- First submitted
- 22 Mar 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT05305404
- Acronym / sponsor ID
- R21AA029735
- Conditions
- Alcohol Use Disorder
- Keywords
- Stress, Dexamethasone, Immune system, Cortisol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 31 Mar 2022 (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 is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo
| Arm | Type | Receives |
|---|---|---|
| Guanfacine | Active comparator | Drug: Dexamethasone Oralsingle dose of dexamethasone (1.5mg) administered orally |
| Placebo | Placebo comparator | Drug: Placebosingle dose of placebo administered orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-treatment seeking heavy drinking men and women with AUD
- Age range 18-55,
- Body Mass Index (BMI) of 18-35
- Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
- Able to provide informed written and verbal consent
Key exclusion criteria (9 listed)
- Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
- Unable to remain abstinent for five days
- Need for a medically assisted detoxification
- Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
- Psychotic or severely psychiatrically disabled
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 |
|---|---|---|
| Dexamethasone OralAlso: Decadron, Dexamethasone Intensol, Dexasone, Solurex, and Baycadron.1.5mg oral dexamethasone to be administered once at 11:00PM | Drug | Guanfacine |
| Placebooral placebo to be administered once at 11:00PM | Drug | Placebo |
Primary outcome
Alcohol craving as assessed using subjective report following stress exposure
Time frame: Change from baseline to +5 minutes following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Alcohol craving as assessed using subjective report following stress exposure
Time frame: Change from baseline to +15 minutes following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Alcohol craving as assessed using subjective report following stress exposure
Time frame: Change from baseline to +30 minutes following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Alcohol craving as assessed using subjective report following stress exposure
Time frame: Change from baseline to +5 minutes following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Alcohol craving as assessed using subjective report following stress exposure
Time frame: Change from baseline to +15 minutes following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Alcohol craving as assessed using subjective report following stress exposure
Time frame: Change from baseline to +30 minutes following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by cortisol
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by cortisol
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma ACTH will be collected following exposure to stress
HPA axis response to stress exposure as assessed by ACTH
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma ACTH will be collected following exposure to stress
HPA axis response to stress exposure as assessed by ACTH
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma ACTH will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma IL-10 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma IL-10 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma IL1-ra will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma IL1-ra will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma IL-6 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma IL-6 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma IL-6 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma TNFa will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma TNFa will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +5 minutes following stress exposure
4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +15 minutes following stress exposure
4mls of plasma TNFR1 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
Time frame: Change from baseline to +30 minutes following stress exposure
4mls of plasma TNFR1 will be collected following exposure to stress
6 secondary outcomes
Anxiety as assessed using subjective report following stress exposure
Time frame: Change from baseline to +5 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
Time frame: Change from baseline to +15 minutes following stress exposure
Anxiety as assessed using subjective report following stress exposure
Time frame: Change from baseline to +30 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Time frame: Change from baseline to +5 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Time frame: Change from baseline to +15 minutes following stress exposure
Negative Mood as assessed using subjective report following stress exposure
Time frame: Change from baseline to +30 minutes following stress exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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. This study is not recruiting at the moment.
Helen C Fox, PhD principal investigator
Indiana University School of Medicine, Dept. of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone Oral in people with Alcohol Use Disorder, run by Stony Brook University 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 2 Oct 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol craving as assessed using subjective report following stress exposure (time frame: Change from baseline to +5 minutes following stress exposure). The study lists 27 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 2 Oct 2026.