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Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Oral
Placebo
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Stress, Dexamethasone, Immune system, Cortisol

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-treatment seeking heavy drinking men and women with AUD
  • Age range 18-55,
  • Body Mass Index (BMI) of 18-35
  • Positive ethylglucuronide (EtG) urine toxicology screen for alcohol
  • Able to provide informed written and verbal consent
  • Able to read English and complete study evaluations
  • Good health as verified by screening examination.

Exclusion Criteria:

  • Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine
  • Unable to remain abstinent for five days
  • Need for a medically assisted detoxification
  • Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs)
  • Psychotic or severely psychiatrically disabled
  • Significant underlying medical conditions which would be of potential harm
  • Pregnancy or breast feeding women;
  • Women using monophasic contraceptives
  • Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of >450 msec for men and QTc>470 msec for women).

Sites / Locations

  • The Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Guanfacine

Placebo

Arm Description

single dose of dexamethasone (1.5mg) administered orally

single dose of placebo administered orally

Outcomes

Primary Outcome Measures

Alcohol craving as assessed using subjective report following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Alcohol craving as assessed using subjective report following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Alcohol craving as assessed using subjective report following stress exposure
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Alcohol craving as assessed using subjective report following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Alcohol craving as assessed using subjective report following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Alcohol craving as assessed using subjective report following stress exposure
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by cortisol
4mls of plasma cortisol will be collected following exposure to stress
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
4mls of plasma ACTH will be collected following exposure to stress
HPA axis response to stress exposure as assessed by ACTH
4mls of plasma ACTH will be collected following exposure to stress
HPA axis response to stress exposure as assessed by ACTH
4mls of plasma ACTH will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-10 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-10 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL1-ra will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL1-ra will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma IL-6 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFa will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFa will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFR1 will be collected following exposure to stress
Immune system response to stress exposure as assessed by peripheral cytokines
4mls of plasma TNFR1 will be collected following exposure to stress

Secondary Outcome Measures

Anxiety as assessed using subjective report following stress exposure
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Anxiety as assessed using subjective report following stress exposure
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Anxiety as assessed using subjective report following stress exposure
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Negative Mood as assessed using subjective report following stress exposure
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Negative Mood as assessed using subjective report following stress exposure
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Negative Mood as assessed using subjective report following stress exposure
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely

Full Information

First Posted
March 22, 2022
Last Updated
July 25, 2022
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT05305404
Brief Title
Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving
Official Title
Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
June 23, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook 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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double-blind, placebo-controlled, proof of concept laboratory study to recruit N=70 (35 Males / 35 Females) non-treatment seeking, heavy drinkers with alcohol use disorder (AUD). It is hypothesized that randomization to 1.5mgs dexamethasone versus placebo will decrease alcohol craving during stress by decreasing basal cortisol, increasing anti-inflammatory cytokine levels and potentially normalizing the immune response to stress.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Stress, Dexamethasone, Immune system, Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a two arm assignment where participants are randomized to a single dose dexamethasone (1.5mg) or placebo
Masking
ParticipantInvestigator
Masking Description
Study is double blind, where participants and investigators are blind to the medication assignment
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine
Arm Type
Active Comparator
Arm Description
single dose of dexamethasone (1.5mg) administered orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
single dose of placebo administered orally
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral
Other Intervention Name(s)
Decadron, Dexamethasone Intensol, Dexasone, Solurex, and Baycadron.
Intervention Description
1.5mg oral dexamethasone to be administered once at 11:00PM
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral placebo to be administered once at 11:00PM
Primary Outcome Measure Information:
Title
Alcohol craving as assessed using subjective report following stress exposure
Description
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Alcohol craving as assessed using subjective report following stress exposure
Description
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Alcohol craving as assessed using subjective report following stress exposure
Description
The 8-item Alcohol Urges Questionnaire (AUQ) will be used to measure alcohol craving. There are 8 items, each with a Likert scale response from 1 to 7 (1: Strongly Disagree, 7: Strongly Agree). Total possible score of 56. The higher the score the higher the alcohol craving
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Alcohol craving as assessed using subjective report following stress exposure
Description
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Alcohol craving as assessed using subjective report following stress exposure
Description
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Alcohol craving as assessed using subjective report following stress exposure
Description
A visual analog scale will be used to measure alcohol craving. Participants will be required to rate "how much they are craving alcohol right at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Hypothalamic-Pituitary-Adrenal (HPA)-axis response to stress exposure as assessed by cortisol
Description
4mls of plasma cortisol will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
HPA axis response to stress exposure as assessed by cortisol
Description
4mls of plasma cortisol will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
HPA axis response to stress exposure as assessed by cortisol
Description
4mls of plasma cortisol will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
HPA axis response to stress exposure as assessed by Adrenocorticotropic Hormone (ACTH)
Description
4mls of plasma ACTH will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
HPA axis response to stress exposure as assessed by ACTH
Description
4mls of plasma ACTH will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
HPA axis response to stress exposure as assessed by ACTH
Description
4mls of plasma ACTH will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma Interleukin (IL)-10 will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL-10 will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL-10 will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma Interleukin 1 receptor antagonist (IL1-ra) will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL1-ra will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL1-ra will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL-6 will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL-6 will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma IL-6 will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma Tumor Necrosis Factor alpha (TNFa) will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma TNFa will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma TNFa will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma Tumor Necrosis Factor Receptor 1 (TNFR1) will be collected following exposure to stress
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma TNFR1 will be collected following exposure to stress
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Immune system response to stress exposure as assessed by peripheral cytokines
Description
4mls of plasma TNFR1 will be collected following exposure to stress
Time Frame
Change from baseline to +30 minutes following stress exposure
Secondary Outcome Measure Information:
Title
Anxiety as assessed using subjective report following stress exposure
Description
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Anxiety as assessed using subjective report following stress exposure
Description
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Anxiety as assessed using subjective report following stress exposure
Description
A visual analog scale will be used to measure anxiety. Participants will be required to rate "how nervous, anxious or jittery they are feeling at this moment". The scale will be anchored from 1 to 10 (1: Not at all, 10: Extremely)
Time Frame
Change from baseline to +30 minutes following stress exposure
Title
Negative Mood as assessed using subjective report following stress exposure
Description
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Time Frame
Change from baseline to +5 minutes following stress exposure
Title
Negative Mood as assessed using subjective report following stress exposure
Description
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Time Frame
Change from baseline to +15 minutes following stress exposure
Title
Negative Mood as assessed using subjective report following stress exposure
Description
The Differential Emotion Scale will be used to measure negative mood. Participants will be required to rate on a 5-point scale the extent to which an emotional word describes the way they feel at the current time. 1: not at all, 5: Extremely
Time Frame
Change from baseline to +30 minutes following stress exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-treatment seeking heavy drinking men and women with AUD Age range 18-55, Body Mass Index (BMI) of 18-35 Positive ethylglucuronide (EtG) urine toxicology screen for alcohol Able to provide informed written and verbal consent Able to read English and complete study evaluations Good health as verified by screening examination. Exclusion Criteria: Meet criteria for Substance Use Disorder (SUD) or other psychoactive substances, excluding nicotine Unable to remain abstinent for five days Need for a medically assisted detoxification Regular use of steroids, anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of stabilization on Selective Serotonin Re-uptake Inhibitors (SSRIs) Psychotic or severely psychiatrically disabled Significant underlying medical conditions which would be of potential harm Pregnancy or breast feeding women; Women using monophasic contraceptives Electrocardiogram (EKG) evidence of clinically significant conduction abnormalities, (Bazlett's corrected QT (QTc) interval of >450 msec for men and QTc>470 msec for women).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen C Fox, PhD
Phone
631 638 0057
Email
helen.fox@stonybrookmedicine.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin C Vacey
Phone
631 638 1545
Email
erin.vacey@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen C Fox, PhD
Organizational Affiliation
Stony Brook Renaissance School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Health Sciences Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Fox, PhD
Phone
631-638-0057
Email
helen.fox@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Erin Vacey
Phone
631 638 1545
Email
erin.vacey@stonybrookmedicine.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexamethasone to Target Stress and Immune System Mechanisms Underlying Alcohol Craving

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