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Effect of Allopregnanolone on Stress-induced Craving

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Allopregnanolone
Placebos
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use Disorder

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-treatment seeking individuals with current DSM-5 AUD
  • No current substance use disorder (except tobacco, alcohol, and marijuana)
  • No current medical problems and normal ECG
  • For women, not pregnant as determined by pregnancy screening, not breast feeding.

Exclusion Criteria:

  • Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
  • History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
  • Liver function tests (ALT or AST) greater than 3 times normal
  • weight >120kg
  • renal impairment
  • patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals

Sites / Locations

  • VA Connecticut Healtcase System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

allopregnanolone

placebo

Arm Description

allopregnanolone

placebo

Outcomes

Primary Outcome Measures

Alcohol Urge Questionnaire (AUQ)
The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point Likert scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Scores range from 8-56
The State-Trait Anxiety Inventory (STAI-6)
The State Trait Anxiety Inventory (STAI-6) is a psychological inventory based on a 4-point likert scale with 6 questions and is self-report. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. Scores range from 20-80.

Secondary Outcome Measures

Biphasic Alcohol Effects scale (BAES)
The Biphasic Alcohol Effects Scale (BAES) is a 14-item self-report adjective rating scale that will be used to measure the stimulant and sedative effects of alcohol. Scores range from 0-140

Full Information

First Posted
April 11, 2019
Last Updated
October 19, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04015869
Brief Title
Effect of Allopregnanolone on Stress-induced Craving
Official Title
Effect of Allopregnanolone on Stress-induced Craving
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.
Detailed Description
This is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk" drinkers to 2 groups: targeted dose of targeted dose of 100 nM of ALLO (N=30) or placebo (N=30). Participants will receive a continuous infusion of ALLO (or placebo) for 175 min. Sixty min. after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Participants will be presented with a stress cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5 min. scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 min after (recovery).The study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind, placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
allopregnanolone
Arm Type
Active Comparator
Arm Description
allopregnanolone
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Allopregnanolone
Intervention Description
neurosteroid
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Alcohol Urge Questionnaire (AUQ)
Description
The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point Likert scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Scores range from 8-56
Time Frame
15 minutes
Title
The State-Trait Anxiety Inventory (STAI-6)
Description
The State Trait Anxiety Inventory (STAI-6) is a psychological inventory based on a 4-point likert scale with 6 questions and is self-report. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. Scores range from 20-80.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Biphasic Alcohol Effects scale (BAES)
Description
The Biphasic Alcohol Effects Scale (BAES) is a 14-item self-report adjective rating scale that will be used to measure the stimulant and sedative effects of alcohol. Scores range from 0-140
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-treatment seeking individuals with current DSM-5 AUD No current substance use disorder (except tobacco, alcohol, and marijuana) No current medical problems and normal ECG For women, not pregnant as determined by pregnancy screening, not breast feeding. Exclusion Criteria: Current major psychiatric illnesses including mood, psychotic, or anxiety disorders History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study Liver function tests (ALT or AST) greater than 3 times normal weight >120kg renal impairment patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ralevski, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healtcase System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Allopregnanolone on Stress-induced Craving

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