Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Alcohol Drinking Clinical Trial

Official title:

Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896489
• Other study ID #: 2000026404
• Status: Completed
• Phase: Early Phase 1
• Start date: May 12, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: June 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Drinking Behavior
• Episodic Memory

Intervention

Drug:
• Hydrocortisone 20 MG
Participants receive Hydrocortisone 20 MG

Other:
• Placebo
Participants receive placebo

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes fMRI signal	Changes in fMRI signal at encoding will be assessed over an hour long period.	1 hour
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Neuroendocrine/cortisol reactivity	Change in salivary cortisol levels following the hydrocortisone/placebo administration.	Baseline to 2 hours