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Completed

NCT Number: NCT04896489

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Episodic Memory Long-term Memory

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydrocortisone 20 MG

Drug

Participants receive Hydrocortisone 20 MG

Placebo

Other

Participants receive placebo

Primary outcomes

  1. Changes fMRI signal

    Time frame: 1 hour

    Changes in fMRI signal at encoding will be assessed over an hour long period.

  2. Item memory

    Time frame: 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.

  3. Context memory

    Time frame: 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.

  4. Affect memory

    Time frame: 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 outcomes

  1. Alcohol motivation

    Time frame: 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.

  2. Affect - Negative

    Time frame: 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.

  3. Affect - Positive

    Time frame: 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.

  4. Neuroendocrine/cortisol reactivity

    Time frame: Baseline to 2 hours

    Change in salivary cortisol levels following the hydrocortisone/placebo administration.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 21, 2021
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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