Alcohol DrinkingEarly Phase 1NCT04896489
Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
A Early Phase 1 study testing Hydrocortisone 20 MG in people with Alcohol Drinking and Drinking Behavior, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Drinking Behavior, Episodic Memory
- What is being tested?
- Hydrocortisone 20 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 15 Mar 2022
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read and write English
- BMI 18-35
- Beer drinking
Who cannot join
- Meet current criteria for any substance use disorder, excluding caffeine
- Current significant medical conditions or psychiatric symptoms requiring medication
- Current use of medications/drugs that interfere with the HPA axis response
- Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
- Metal in body (for MRI safety)
- Systemic fungal infections (contraindication for hydrocortisone)
- Known hypersensitivity to components of hydrocortisone tablets (hydrocortisone, calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.
Read the detailed description
This study aims to 1) Characterize the effect of elevated glucocorticoids during encoding on long-term memory for alcohol-related information; 2) Identify the neural mechanisms by which glucocorticoids influence encoding of alcohol-related experiences; and 3) Determine how glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving alcohol-related memories.
- Conditions
- Alcohol Drinking, Drinking Behavior, Episodic Memory, Long-term Memory
- Being tested
- Hydrocortisone 20 MG, Placebo
- Medical subject headings
- Alcohol Drinking, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone 20 MGDrug
Participants receive Hydrocortisone 20 MG
PlaceboOther
Participants receive placebo
| Study group | Role | What they receive |
|---|---|---|
| hydrocortisone | Experimental | Participants receive hydrocortisone (20mg) Receives: Drug: Hydrocortisone 20 MG |
| placebo | Placebo comparator | Participants receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes fMRI signal
Changes in fMRI signal at encoding will be assessed over an hour long period.
Measured: 1 hour
Item memory
Item memory will be assessed through performance on delayed memory assessments. Item memory is determined by the accuracy of memory for individual items and will be expressed as dprime.
Measured: Up to 90 minutes
Context memory
Context memory will be assessed through performance on delayed memory assessments. Context memory is determined by the accuracy of memory for associated contexts and will be expressed as % correct.
Measured: Up to 90 minutes
Affect memory
Affect memory will be assessed through performance on delayed memory assessments. Affect memory is determined by subjective ratings of vividness (1-4), change in ratings from encoding to retrieval of memory (0-3). The score is averaged where a higher score indicates greater affect.
Measured: Up to 90 minutes
Secondary outcomes (4)
Alcohol motivation
Performance on alcohol taste test following memory retrieval will be assessed using the Alcohol Taste Test (ATT). The test asks participants to taste the alcohol in each two containers to identify whether the alcohol was the same or different. The % correct is used to assess this outcome.
Measured: 10 minutes
Affect - Negative
Self-reported measures of emotional state following drug administration and memory retrieval using the PANAS. The negative subscale of the PANAS will be used and has a range of 10-50. Higher scores indicate higher negative affect.
Measured: 10 minutes
Affect - Positive
Self-reported measures of emotional state following drug administration and memory retrieval using the PANAS. The negative subscale of the PANAS will be used and has a range of 10-50. Higher scores indicate higher positive affect.
Measured: 10 minutes
Neuroendocrine/cortisol reactivity
Change in salivary cortisol levels following the hydrocortisone/placebo administration.
Measured: Baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start12 May 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth V Goldfarb, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896489
- Sponsor's protocol ID
- 2000026404
- Status last verified
- Jun 2022
- First submitted
- 17 May 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in published articles will be shared after de-identification.
Publications
Huang Y, O'Connor D, Harris BB, Sinha R, Constable RT, Goldfarb EV. Dynamic brain mechanisms supporting salient memories under cortisol. Sci Adv. 2025 Dec 12;11(50):eadz4143. doi: 10.1126/sciadv.adz4143. Epub 2025 Dec 10.
PubMed 41370392
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
- ClinicalTrials.gov ID
- NCT04896489
- Acronym / sponsor ID
- 2000026404
- Conditions
- Alcohol Drinking, Drinking Behavior, Episodic Memory, Long-term Memory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 21 May 2021 (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.
The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.
Detailed description
This study aims to 1) Characterize the effect of elevated glucocorticoids during encoding on long-term memory for alcohol-related information; 2) Identify the neural mechanisms by which glucocorticoids influence encoding of alcohol-related experiences; and 3) Determine how glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving alcohol-related memories.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrocortisone | Experimental | Drug: Hydrocortisone 20 MGParticipants receive hydrocortisone (20mg) |
| placebo | Placebo comparator | Other: PlaceboParticipants receive placebo. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to read and write English
- BMI 18-35
- Beer drinking
Key exclusion criteria (7 listed)
- Meet current criteria for any substance use disorder, excluding caffeine
- Current significant medical conditions or psychiatric symptoms requiring medication
- Current use of medications/drugs that interfere with the HPA axis response
- Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
- Metal in body (for MRI safety)
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 |
|---|---|---|
| Hydrocortisone 20 MGParticipants receive Hydrocortisone 20 MG | Drug | hydrocortisone |
| PlaceboParticipants receive placebo | Other | placebo |
Primary outcome
Changes fMRI signal
Time frame: 1 hour
Changes in fMRI signal at encoding will be assessed over an hour long period.
Item memory
Time frame: Up to 90 minutes
Item memory will be assessed through performance on delayed memory assessments. Item memory is determined by the accuracy of memory for individual items and will be expressed as dprime.
Context memory
Time frame: Up to 90 minutes
Context memory will be assessed through performance on delayed memory assessments. Context memory is determined by the accuracy of memory for associated contexts and will be expressed as % correct.
Affect memory
Time frame: Up to 90 minutes
Affect memory will be assessed through performance on delayed memory assessments. Affect memory is determined by subjective ratings of vividness (1-4), change in ratings from encoding to retrieval of memory (0-3). The score is averaged where a higher score indicates greater affect.
4 secondary outcomes
Alcohol motivation
Time frame: 10 minutes
Affect - Negative
Time frame: 10 minutes
Affect - Positive
Time frame: 10 minutes
Neuroendocrine/cortisol reactivity
Time frame: Baseline to 2 hours
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 Jun 2022.
- Derived from this study: PubMed 41370392Huang Y, O'Connor D, Harris BB, Sinha R, Constable RT, Goldfarb EV. Dynamic brain mechanisms supporting salient memories under cortisol. Sci Adv. 2025 Dec 12;11(50):eadz4143. doi: 10.1126/sciadv.adz4143. Epub 2025 Dec 10.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in published articles will be shared after de-identification.
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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. This study is not recruiting at the moment.
Elizabeth V Goldfarb, PhD principal investigator
Yale University
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 Hydrocortisone 20 MG in people with Alcohol Drinking and Drinking Behavior, run by Yale 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 3 inclusion and 7 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 Jun 2022. 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?
Changes fMRI signal (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896489, which also lists 1 linked publication.
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 Jun 2022.