Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Early Phase 1

Completed

• Conditions: Alcohol Drinking; Drinking Behavior; Episodic Memory; Long-term Memory
• Interventions: Drug: Hydrocortisone 20 MG; Other: Placebo

• Registration Number: NCT04896489
• Lead Sponsor: Yale University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-12
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-21
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Able to read and write English
• BMI 18-35
• Beer drinking

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hydrocortisone	Hydrocortisone 20 MG	Participants receive hydrocortisone (20mg)
placebo	Placebo	Participants receive placebo.

Primary Outcome Measures

Name	Time	Method
Changes fMRI signal	1 hour	Changes in fMRI signal at encoding will be assessed over an hour long period.
Item memory	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Alcohol motivation	10 minutes	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.
Affect - Negative	10 minutes	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.
Affect - Positive	10 minutes	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.
Neuroendocrine/cortisol reactivity	Baseline to 2 hours	Change in salivary cortisol levels following the hydrocortisone/placebo administration.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States