An Early Phase 1 interventional study of Hydrocortisone 20 MG and Placebo in Alcohol Drinking, Drinking Behavior and Episodic Memory, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by Yale University · Early Phase 1, Interventional, and Basic science
The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 27 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive hydrocortisone (20mg)
Drug: Hydrocortisone 20 MG
Participants receive placebo.
Other: Placebo
Participants receive Hydrocortisone 20 MG
Participants receive placebo
Changes fMRI signal
Changes in fMRI signal at encoding will be assessed over an hour long period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 10 minutes
Neuroendocrine/cortisol reactivity
Change in salivary cortisol levels following the hydrocortisone/placebo administration.
Time frame: Baseline to 2 hours
Plan to share: Yes — Individual participant data that underlie the results reported in published articles will be shared after de-identification.
Supporting information: Study protocol
Time frame: Immediately following publication with no end date.
Access criteria: Anyone who wishes to have access to the data may do so.
No publications or documents are linked to this record.
Ran from May 2021 to primary completion in Mar 2022, 10 months.
Of 32 non-industry phase 1 interventional studies under Alcohol Drinking, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 49. This study's 10 months is below that.
Counting every sponsor, half of 34 studies reached it within 37 months; a quarter within 21 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone