Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking

NCT04896489 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2000026404
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Drinking; Drinking Behavior; Episodic Memory; Long-term Memory

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Alcohol motivation

  10 minutes

• Affect - Negative

  10 minutes

• Affect - Positive

  10 minutes

• Neuroendocrine/cortisol reactivity

  Baseline to 2 hours

Study Arms (2)

hydrocortisone

EXPERIMENTAL

Participants receive hydrocortisone (20mg)

Drug: Hydrocortisone 20 MG

placebo

PLACEBO COMPARATOR

Participants receive placebo.

Other: Placebo

Interventions

Hydrocortisone 20 MG DRUG

Participants receive Hydrocortisone 20 MG

hydrocortisone

Placebo OTHER

Participants receive placebo

placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Drinking Behavior

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Elizabeth V Goldfarb, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 21, 2021
• Study Start: May 12, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)