Back to resultsNeuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
Primary Purpose
Alcohol Drinking, Drinking Behavior, Episodic Memory
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone 20 MG
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking
Eligibility Criteria
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)
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
hydrocortisone
placebo
Arm Description
Participants receive hydrocortisone (20mg)
Participants receive placebo.
Outcomes
Primary Outcome Measures
Changes fMRI signal
Changes in fMRI signal at encoding will be assessed over an hour long period.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Neuroendocrine/cortisol reactivity
Change in salivary cortisol levels following the hydrocortisone/placebo administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04896489
Brief Title
Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
Official Title
Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Drinking Behavior, Episodic Memory, Long-term Memory
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydrocortisone
Arm Type
Experimental
Arm Description
Participants receive hydrocortisone (20mg)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone 20 MG
Intervention Description
Participants receive Hydrocortisone 20 MG
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants receive placebo
Primary Outcome Measure Information:
Title
Changes fMRI signal
Description
Changes in fMRI signal at encoding will be assessed over an hour long period.
Time Frame
1 hour
Title
Item memory
Description
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.
Time Frame
Up to 90 minutes
Title
Context memory
Description
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.
Time Frame
Up to 90 minutes
Title
Affect memory
Description
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.
Time Frame
Up to 90 minutes
Secondary Outcome Measure Information:
Title
Alcohol motivation
Description
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.
Time Frame
10 minutes
Title
Affect - Negative
Description
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.
Time Frame
10 minutes
Title
Affect - Positive
Description
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.
Time Frame
10 minutes
Title
Neuroendocrine/cortisol reactivity
Description
Change in salivary cortisol levels following the hydrocortisone/placebo administration.
Time Frame
Baseline to 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth V Goldfarb, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
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