Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Drinking Behavior; Episodic Memory; Long-term Memory
• Intervention / Treatment: Drug: Hydrocortisone 20 MG; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydrocortisone; Participants receive hydrocortisone (20mg)	Drug: Hydrocortisone 20 MG; Participants receive Hydrocortisone 20 MG
Placebo Comparator: placebo; Participants receive placebo.	Other: Placebo; Participants receive placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes fMRI signal	Changes in fMRI signal at encoding will be assessed over an hour long period.	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.	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.	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.	Up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	10 minutes
Neuroendocrine/cortisol reactivity	Change in salivary cortisol levels following the hydrocortisone/placebo administration.	Baseline to 2 hours

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Elizabeth V Goldfarb, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Alcohol Drinking; Drinking Behavior; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 2000026404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in published articles will be shared after de-identification.
• IPD Sharing Time Frame: Immediately following publication with no end date.
• IPD Sharing Access Criteria: Anyone who wishes to have access to the data may do so.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes