Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT04896489

Collaborator

(none)

Enrollment

Location

Arms

10.1

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Drinking Behavior Episodic Memory Long-term Memory	Drug: Hydrocortisone 20 MG Other: Placebo	Early Phase 1

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

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Actual Study Start Date :

May 12, 2021

Actual Primary Completion Date :

Mar 15, 2022

Actual Study Completion Date :

Mar 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Elizabeth V Goldfarb, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT04896489

Other Study ID Numbers:

2000026404

First Posted:

May 21, 2021

Last Update Posted:

Jun 2, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Alcohol Drinking

Drinking Behavior

Hydrocortisone

Study Results

No Results Posted as of Jun 2, 2022