Back to resultsInfluence of n-Acetylcysteine Maintenance on Alcohol Effects
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Placebos
N-acetyl cysteine
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- able to speak/read English
- not seeking treatment at the time of the study
- one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
- recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
- ECG within normal limits
- otherwise healthy
- body mass index of 19-35
- females using an effective form of birth control and not pregnant or breast feeding
- judged by the medical staff to be psychiatrically and physically healthy
- able to abstain from alcohol for 12 hours prior to session
- no contraindications/allergies to n-acetylcysteine
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Low Dose n-Acetylcysteine
High Dose n-Acetylcysteine
Arm Description
Subjects will receive oral placebo capsules two times daily.
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Outcomes
Primary Outcome Measures
Number of Alcohol Drinks Chosen
The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine.
Secondary Outcome Measures
Full Information
NCT ID
NCT03216954
First Posted
July 7, 2017
Last Updated
January 5, 2021
Sponsor
William Stoops
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03216954
Brief Title
Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Official Title
A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
April 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William Stoops
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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
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
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive oral placebo capsules two times daily.
Arm Title
Low Dose n-Acetylcysteine
Arm Type
Experimental
Arm Description
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
Arm Title
High Dose n-Acetylcysteine
Arm Type
Experimental
Arm Description
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Subjects will receive placebo capsules
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Description
Subjects will receive n-acetyl cysteine capsules
Primary Outcome Measure Information:
Title
Number of Alcohol Drinks Chosen
Description
The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine.
Time Frame
After at least four days of placebo or n-acetylcysteine maintenance
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
able to speak/read English
not seeking treatment at the time of the study
one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
ECG within normal limits
otherwise healthy
body mass index of 19-35
females using an effective form of birth control and not pregnant or breast feeding
judged by the medical staff to be psychiatrically and physically healthy
able to abstain from alcohol for 12 hours prior to session
no contraindications/allergies to n-acetylcysteine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William W Stoops, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40507
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of n-Acetylcysteine Maintenance on Alcohol Effects
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