Trial Outcomes & Findings for N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence (NCT NCT01214083)
NCT ID: NCT01214083
Last Updated: 2020-04-08
Results Overview
"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
week 1 and week 13
Results posted on
2020-04-08
Participant Flow
A total of 111 subjects signed consent. Of 111 subjects, 95 subjects were qualified for the trial.
Participant milestones
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
31
|
|
Overall Study
COMPLETED
|
19
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Baseline characteristics by cohort
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 1 and week 13"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).
Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Percentage of Heavy Drinking Days
Percentage of heavy drinking days at week 1
|
45.0 percentage of heavy drinking days
Standard Error 4.5
|
50.6 percentage of heavy drinking days
Standard Error 4.3
|
44.0 percentage of heavy drinking days
Standard Error 4.5
|
|
Percentage of Heavy Drinking Days
Percentage of heavy drinking days at week 13
|
5.2 percentage of heavy drinking days
Standard Error 5.6
|
3.4 percentage of heavy drinking days
Standard Error 5.1
|
3.3 percentage of heavy drinking days
Standard Error 5.3
|
SECONDARY outcome
Timeframe: week 0 and week 13Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Liver Function Tests (AST)
Liver function tests (AST) at week 0
|
34.7 units/liter
Standard Error 6.6
|
29.0 units/liter
Standard Error 6.4
|
30.0 units/liter
Standard Error 6.6
|
|
Liver Function Tests (AST)
Liver function tests (AST) at week 13
|
27.3 units/liter
Standard Error 7.9
|
32.1 units/liter
Standard Error 7.4
|
22.2 units/liter
Standard Error 7.5
|
SECONDARY outcome
Timeframe: week 1 and week 13The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving).
Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Penn Alcohol Craving Scale (PACS)
Penn Alcohol Craving Scale at week 1
|
18.0 units on a scale
Standard Error 1.1
|
18.4 units on a scale
Standard Error 1.1
|
16.1 units on a scale
Standard Error 1.1
|
|
Penn Alcohol Craving Scale (PACS)
Penn Alcohol Craving Scale at week 13
|
7.2 units on a scale
Standard Error 1.4
|
8.3 units on a scale
Standard Error 1.3
|
6.3 units on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: week 1 and week 13The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems).
Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Obsessive Compulsive Drinking Scale (OCDS)
Obsessive Compulsive Drinking Scale at week 1
|
28.2 units on a scale
Standard Error 1.8
|
29.0 units on a scale
Standard Error 1.7
|
24.5 units on a scale
Standard Error 1.8
|
|
Obsessive Compulsive Drinking Scale (OCDS)
Obsessive Compulsive Drinking Scale at week 13
|
9.1 units on a scale
Standard Error 2.1
|
14.0 units on a scale
Standard Error 1.9
|
9.0 units on a scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: week 1 and week 13The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness).
Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Clinical Global Impression (CGI)
Clinical Global Impression at week 1
|
3.7 units on a scale
Standard Error 0.1
|
3.7 units on a scale
Standard Error 0.1
|
3.6 units on a scale
Standard Error 0.1
|
|
Clinical Global Impression (CGI)
Clinical Global Impression at week 13
|
1.5 units on a scale
Standard Error 0.2
|
1.7 units on a scale
Standard Error 0.2
|
1.4 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: week 1 and week 13The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life).
Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q at week 1
|
53.2 units on a scale
Standard Error 1.9
|
53.8 units on a scale
Standard Error 1.8
|
55.1 units on a scale
Standard Error 1.9
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q at week 13
|
61.6 units on a scale
Standard Error 2.1
|
59.6 units on a scale
Standard Error 2.0
|
63.9 units on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: week 1 and week 13"Percentage of drinking days" was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days).
Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Percentage of Drinking Days
percentage of drinking days at week 1
|
64.6 percentage of drinking days
Standard Error 6.3
|
63.8 percentage of drinking days
Standard Error 6.1
|
55.3 percentage of drinking days
Standard Error 6.3
|
|
Percentage of Drinking Days
percentage of drinking days at week 13
|
21.1 percentage of drinking days
Standard Error 7.6
|
24.5 percentage of drinking days
Standard Error 7.0
|
18.2 percentage of drinking days
Standard Error 7.3
|
SECONDARY outcome
Timeframe: week 1 and week 13Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Drinks Per Drinking Days
drinks per drinking days at week 1
|
7.3 drinks/drinking day
Standard Error 0.6
|
5.9 drinks/drinking day
Standard Error 0.6
|
7.3 drinks/drinking day
Standard Error 0.6
|
|
Drinks Per Drinking Days
drinks per drinking days at week 13
|
1.1 drinks/drinking day
Standard Error 0.6
|
1.2 drinks/drinking day
Standard Error 0.6
|
1.0 drinks/drinking day
Standard Error 0.6
|
SECONDARY outcome
Timeframe: week 0 and week 13Outcome measures
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 Participants
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 Participants
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 Participants
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Liver Function Tests (ALT)
Liver Function Tests (ALT) at week 0
|
49.4 units/liter
Standard Error 12.0
|
36.5 units/liter
Standard Error 11.6
|
34.7 units/liter
Standard Error 12.0
|
|
Liver Function Tests (ALT)
Liver Function Tests (ALT) at week 13
|
27.6 units/liter
Standard Error 13.9
|
40.1 units/liter
Standard Error 13.0
|
31.3 units/liter
Standard Error 13.2
|
Adverse Events
N-acetylcysteine + High-dose Naltrexone (150 mg)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
High-dose Naltrexone (150 mg) Alone
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Low-dose Naltrexone (50 mg) Alone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetylcysteine + High-dose Naltrexone (150 mg)
n=31 participants at risk
N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
|
High-dose Naltrexone (150 mg) Alone
n=33 participants at risk
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
Low-dose Naltrexone (50 mg) Alone
n=31 participants at risk
Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
29.0%
9/31
|
27.3%
9/33
|
16.1%
5/31
|
|
General disorders
Drowsiness
|
3.2%
1/31
|
12.1%
4/33
|
0.00%
0/31
|
|
General disorders
Headache
|
9.7%
3/31
|
3.0%
1/33
|
6.5%
2/31
|
|
General disorders
Decreased appetite
|
6.5%
2/31
|
3.0%
1/33
|
6.5%
2/31
|
|
General disorders
Dry mouth
|
6.5%
2/31
|
6.1%
2/33
|
0.00%
0/31
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/31
|
6.1%
2/33
|
6.5%
2/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place