Trial Outcomes & Findings for Influence of n-Acetylcysteine Maintenance on Alcohol Effects (NCT NCT03216954)
NCT ID: NCT03216954
Last Updated: 2021-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
14 participants
Primary outcome timeframe
After at least four days of placebo or n-acetylcysteine maintenance
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Placebo Then 1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine
Subjects were maintained on placebo for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days.
|
2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine Then Placebo
Subjects were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on placebo for 5 days.
|
Placebo Then 2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine
Subjects were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine, then they were maintained on 1.2 g n-acetylcysteine.
|
1.2 g n-Acetylcysteine Then Placebo Then 2.4 g n-Acetylcysteine
Subjects were maintained on 1.2 g n-acetylcysteine for 5 days, then they were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days.
|
1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine Then Placebo
Subjects were maintained on 1.2 g n-acetylcysteine for 5 days then they were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo Then 1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine
Subjects were maintained on placebo for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days.
|
2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine Then Placebo
Subjects were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on placebo for 5 days.
|
Placebo Then 2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine
Subjects were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine, then they were maintained on 1.2 g n-acetylcysteine.
|
1.2 g n-Acetylcysteine Then Placebo Then 2.4 g n-Acetylcysteine
Subjects were maintained on 1.2 g n-acetylcysteine for 5 days, then they were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days.
|
1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine Then Placebo
Subjects were maintained on 1.2 g n-acetylcysteine for 5 days then they were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on placebo.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject used cocaine during participation, which is an exclusion criterion.
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Baseline characteristics by cohort
| Measure |
Crossover Study Drug Conditions
n=9 Participants
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.
|
|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After at least four days of placebo or n-acetylcysteine maintenancePopulation: Completing Subjects
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.
Outcome measures
| Measure |
Placebo
n=9 Participants
Subjects received oral placebo capsules two times daily.
Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos: Subjects will receive placebo capsules
|
Low Dose n-Acetylcysteine
n=9 Participants
Subjects received 0.6 g oral n-acetylcysteine two times daily.
Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
N-acetyl cysteine: Subjects will receive n-acetyl cysteine capsules
|
High Dose n-Acetylcysteine
n=9 Participants
Subjects received 1.2 g oral n-acetylcysteine two times daily.
Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
N-acetyl cysteine: Subjects will receive n-acetyl cysteine capsules
|
|---|---|---|---|
|
Number of Alcohol Drinks Chosen
|
3.1 Number of Alcohol Drinks Chosen
Standard Deviation 3.5
|
2.8 Number of Alcohol Drinks Chosen
Standard Deviation 3.5
|
3.8 Number of Alcohol Drinks Chosen
Standard Deviation 3.6
|
Adverse Events
Placebo Maintenance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1.2 g n-Acetylcysteine Maintenance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2.4 g n-Acetylcysteine Maintenance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Maintenance
n=14 participants at risk
Subjects received oral placebo capsules two times daily.
Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos: Subjects received placebo capsules
|
1.2 g n-Acetylcysteine Maintenance
n=14 participants at risk
Subjects received 0.6 g n-acetylcysteine capsules two times daily.
Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos: Subjects received placebo capsules n-Acetylcysteine: Subjects received 0.6 g n-acetylcysteine capsules
|
2.4 g n-Acetylcysteine Maintenance
n=14 participants at risk
Subjects received 1.2 g n-acetylcysteine capsules two times daily.
Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos: Subjects received placebo capsules n-Acetylcysteine: Subjects received 1.2 g n-acetylcysteine capsules
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
|
Eye disorders
Blurry vision
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
7.1%
1/14 • Number of events 1 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
7.1%
1/14 • Number of events 1 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
|
General disorders
Thirst
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
7.1%
1/14 • Number of events 1 • Full duration of each subject's participation, approximately 5 weeks.
|
0.00%
0/14 • Full duration of each subject's participation, approximately 5 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place