Alcohol Use Disorder
Conditions
Brief summary
This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
Interventions
DRUGAlcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
DRUGPlacebos
Subjects will receive placebo capsules
DRUGN-acetyl cysteine
Subjects will receive n-acetyl cysteine capsules
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
William Stoops
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Alcohol Drinks Chosen | After at least four days of placebo or n-acetylcysteine maintenance | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crossover Study Drug Conditions Subjects received oral placebo, 0.6 g n-acetylcysteine or 1.2 g n-acetylcysteine capsules two times daily. Dose condition was assigned in random order and all completing subjects received all dose conditions.
Alcohol: During each condition, subjects received doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos: Subjects received placebo capsules. n-Acetylcysteine: Subjects received n-acetylcysteine capsules. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Subject used cocaine during participation, which is an exclusion criterion. | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Crossover Study Drug Conditions |
|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 1 / 14 | 1 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
Primary
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.
Time frame: After at least four days of placebo or n-acetylcysteine maintenance
Population: Completing Subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Alcohol Drinks Chosen | 3.1 Number of Alcohol Drinks Chosen | Standard Deviation 3.5 |
| Low Dose n-Acetylcysteine | Number of Alcohol Drinks Chosen | 2.8 Number of Alcohol Drinks Chosen | Standard Deviation 3.5 |
| High Dose n-Acetylcysteine | Number of Alcohol Drinks Chosen | 3.8 Number of Alcohol Drinks Chosen | Standard Deviation 3.6 |