Trial Outcomes & Findings for Understanding Treatment Response With Naltrexone Among White Alcoholics (NCT NCT00817089)
NCT ID: NCT00817089
Last Updated: 2019-11-21
Results Overview
Change from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood. Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
during 2nd alcohol challenge session
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
Group 1: Asn40 Placebo Placebo
Asn40: Placebo, Placebo
Each alcohol session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 2: Asn40 Placebo Naltrexone
Asn40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 3: Asp40 Placebo Placebo
Asp40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 4: Asp40 Placebo Naltrexone
Asp40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second challegne alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
|---|---|---|---|---|
|
First Alcohol Challenge
STARTED
|
6
|
8
|
4
|
6
|
|
First Alcohol Challenge
COMPLETED
|
6
|
8
|
4
|
5
|
|
First Alcohol Challenge
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Second Alcohol Challenge
STARTED
|
6
|
8
|
4
|
5
|
|
Second Alcohol Challenge
COMPLETED
|
6
|
7
|
4
|
5
|
|
Second Alcohol Challenge
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Asn40 Placebo Placebo
Asn40: Placebo, Placebo
Each alcohol session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 2: Asn40 Placebo Naltrexone
Asn40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 3: Asp40 Placebo Placebo
Asp40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 4: Asp40 Placebo Naltrexone
Asp40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second challegne alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
|---|---|---|---|---|
|
First Alcohol Challenge
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Second Alcohol Challenge
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Understanding Treatment Response With Naltrexone Among White Alcoholics
Baseline characteristics by cohort
| Measure |
Group 1: Asn40 Placebo Placebo
n=6 Participants
Asn40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 2: Asn40 Placebo Naltrexone
n=8 Participants
Asn40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second challegne alcohol session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 3: Asp40 Placebo Placebo
n=4 Participants
Asp40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 4: Asp40 Placebo Naltrexone
n=6 Participants
Asp40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<21 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Between 21 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Customized
>65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: during 2nd alcohol challenge sessionChange from baseline to peak cortisol response, during the 2nd alcohol challenge session, subjective response as measured by Biphasic Alcohol Effects Scale: Total Mood. Biphasic Alcohol Effects Scale: Total Mood: minimum = 0, maximum = 106, higher scores indicate better outcomes.
Outcome measures
| Measure |
Group 1: Asn40 Placebo Placebo
n=6 Participants
Asn40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 2: Asn40 Placebo Naltrexone
n=7 Participants
Asn40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 3: Asp40 Placebo Placebo
n=4 Participants
Asp40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 4: Asp40 Placebo Naltrexone
n=5 Participants
Asp40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale:Total Mood
|
6.94 units on a scale
Standard Deviation 9.53
|
3.57 units on a scale
Standard Deviation 18.46
|
6.50 units on a scale
Standard Deviation 4.04
|
3.20 units on a scale
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: during 2nd alcohol challenge sessionChange from baseline to peak cortisol response during the 2nd alcohol challenge session, objective response as measured by Adrenocorticotropic hormone (ACTH).
Outcome measures
| Measure |
Group 1: Asn40 Placebo Placebo
n=6 Participants
Asn40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 2: Asn40 Placebo Naltrexone
n=7 Participants
Asn40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 3: Asp40 Placebo Placebo
n=4 Participants
Asp40: Placebo, Placebo
Each alcohol challenge session preceded by pretreatment with placebo.
Placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
Group 4: Asp40 Placebo Naltrexone
n=5 Participants
Asp40: Placebo, Naltrexone
The first alcohol challenge session preceded by pretreatment with placebo. The second alcohol challenge session preceded by pretreatment with naltrexone 50 mg as a single dose.
Placebo: placebo pills
naltrexone: 50 mg of naltrexone prior to challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice
|
|---|---|---|---|---|
|
Adrenocorticotropic Hormone (ACTH) Levels
|
-7.83 pg/ml
Standard Deviation 14.34
|
3.86 pg/ml
Standard Deviation 7.47
|
5.25 pg/ml
Standard Deviation 8.42
|
-3.20 pg/ml
Standard Deviation 14.10
|
Adverse Events
Group 1: Asn40 Placebo Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Asn40 Placebo Naltrexone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Asp40 Placebo Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4: Asp40 Placebo Naltrexone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place