Trial Outcomes & Findings for Endophenotype for Alcohol Misuse in Healthy Minority Populations (NCT NCT00256451)
NCT ID: NCT00256451
Last Updated: 2019-08-21
Results Overview
Change from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
During challenge sessions
Results posted on
2019-08-21
Participant Flow
Participants were only randomized to 4 sequences and not to all 12 possible sequences.
Participant milestones
| Measure |
Ntx-Alc; Placebo-Sham; Ntx-Sham; Placebo-Alc
Session1: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
Session2:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session3: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session4: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Ntx-Sham; Ntx-Alc; Placebo-Alc; Placebo-Sham
Session1: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session2: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
Session3: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
Session4: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol
|
Placebo-Alc; Ntx-Sham; Placebo-Sham; Ntx-Alc
Session1: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
Session2: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol Session3:placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session4: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo-Sham; Placebo-Alc; Ntx-Alc; Ntx-Sham
Session1: placebo naltrexone and placebo (non-alcoholic) alcohol placebo: placebo pills Sham alcohol: non-alcoholic placebo alcohol Session2: placebo naltrexone and alcohol placebo: placebo pills alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
Session3: alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
Session4: "sham" alcohol and active naltrexone Naltrexone: 50 mg/day for two days prior to the alcohol challenge session Sham alcohol: non-alcoholic placebo alcohol
|
|---|---|---|---|---|
|
Session1
STARTED
|
10
|
11
|
11
|
11
|
|
Session1
COMPLETED
|
10
|
11
|
11
|
11
|
|
Session1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Session2
STARTED
|
9
|
11
|
10
|
10
|
|
Session2
COMPLETED
|
9
|
11
|
10
|
10
|
|
Session2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Session3
STARTED
|
9
|
9
|
10
|
9
|
|
Session3
COMPLETED
|
9
|
9
|
10
|
9
|
|
Session3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Session4
STARTED
|
9
|
8
|
10
|
8
|
|
Session4
COMPLETED
|
9
|
8
|
10
|
8
|
|
Session4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endophenotype for Alcohol Misuse in Healthy Minority Populations
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=43 Participants
all participants in the cross over study
|
|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Alcohol use
|
3.2 total number of drinks in the week prior
STANDARD_DEVIATION 4.9 • n=93 Participants
|
PRIMARY outcome
Timeframe: During challenge sessionsChange from baseline to peak for the feeling of stimulation after alcohol ingestion Biphasic Alcohol Effects Scale - Stimulation: sum of 7 items each rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, higher scores=worse outcome.
Outcome measures
| Measure |
ALC and NAL
n=40 Participants
alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo ALC and NAL
n=38 Participants
"sham" alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
Sham alcohol: non-alcoholic placebo alcohol
|
Placebo Pill and ALC
n=39 Participants
placebo naltrexone and alcohol
placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo Pill and Placebo ALC
n=38 Participants
placebo naltrexone and placebo (non-alcoholic) alcohol
placebo: placebo pills
Sham alcohol: non-alcoholic placebo alcohol
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale - Stimulation
|
11.3 units on a scale
Standard Deviation 10.1
|
3.9 units on a scale
Standard Deviation 5.1
|
8.7 units on a scale
Standard Deviation 7.6
|
3.2 units on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: during the challenge sessionChange from baseline to peak for the amount of Vigor experienced after alcohol ingestion Profile of Mood States - Vigor: sum of 6 items each rated on 5 point Likert scale (0: not at all, 4: extremely). Minimum=0, maximum=20, higher scores = better outcome
Outcome measures
| Measure |
ALC and NAL
n=40 Participants
alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo ALC and NAL
n=38 Participants
"sham" alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
Sham alcohol: non-alcoholic placebo alcohol
|
Placebo Pill and ALC
n=39 Participants
placebo naltrexone and alcohol
placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo Pill and Placebo ALC
n=38 Participants
placebo naltrexone and placebo (non-alcoholic) alcohol
placebo: placebo pills
Sham alcohol: non-alcoholic placebo alcohol
|
|---|---|---|---|---|
|
Profile of Mood States - Vigor
|
2.1 units on a scale
Standard Deviation 2.5
|
1.1 units on a scale
Standard Deviation 1.2
|
1.8 units on a scale
Standard Deviation 1.4
|
1.2 units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: during the alcohol ingestionChange from baseline to peak for the self reported feeling of being high after drinking Subjective High from Alcohol Scale: sum of 15 items rated on a 8 point Likert scale (0-7). Minimum=0, maximum=105, higher scores=worse outcomes
Outcome measures
| Measure |
ALC and NAL
n=40 Participants
alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo ALC and NAL
n=38 Participants
"sham" alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
Sham alcohol: non-alcoholic placebo alcohol
|
Placebo Pill and ALC
n=39 Participants
placebo naltrexone and alcohol
placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo Pill and Placebo ALC
n=38 Participants
placebo naltrexone and placebo (non-alcoholic) alcohol
placebo: placebo pills
Sham alcohol: non-alcoholic placebo alcohol
|
|---|---|---|---|---|
|
Subjective High From Alcohol Scale
|
17.9 units on a scale
Standard Deviation 17.2
|
4.5 units on a scale
Standard Deviation 5.4
|
14.7 units on a scale
Standard Deviation 13.1
|
2.7 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: During the challenge sessionChange from baseline to peak of the amount of sedation post ingestion of alcohol Biphasic alcohol effects scale - Sedation: sum of 7 items rated on 11 point Likert scale (0=not at all, 10=extremely). Minimum=0, maximum=70, lower scores=worse outcomes
Outcome measures
| Measure |
ALC and NAL
n=40 Participants
alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo ALC and NAL
n=38 Participants
"sham" alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
Sham alcohol: non-alcoholic placebo alcohol
|
Placebo Pill and ALC
n=39 Participants
placebo naltrexone and alcohol
placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo Pill and Placebo ALC
n=38 Participants
placebo naltrexone and placebo (non-alcoholic) alcohol
placebo: placebo pills
Sham alcohol: non-alcoholic placebo alcohol
|
|---|---|---|---|---|
|
Biphasic Alcohol Effects Scale - Sedation
|
14.8 units on a scale
Standard Deviation 13.7
|
13.4 units on a scale
Standard Deviation 16.1
|
15.9 units on a scale
Standard Deviation 15.8
|
15.4 units on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: During the challenge sessionChange from baseline to peak of the degree of fatigue experienced after alcohol ingestion Profile of Mood States - Fatigue scale: sum of 5 items rated on 5-point Likert scale (0=not at all, 4=extremely). Minimum=0, maximum=20, higher score=worse outcome
Outcome measures
| Measure |
ALC and NAL
n=40 Participants
alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo ALC and NAL
n=38 Participants
"sham" alcohol and active naltrexone
Naltrexone: 50 mg/day for two days prior to the alcohol challenge session
Sham alcohol: non-alcoholic placebo alcohol
|
Placebo Pill and ALC
n=39 Participants
placebo naltrexone and alcohol
placebo: placebo pills
alcohol: 190 proof alcohol prepared to 11% volume mixed with fruit juice.
|
Placebo Pill and Placebo ALC
n=38 Participants
placebo naltrexone and placebo (non-alcoholic) alcohol
placebo: placebo pills
Sham alcohol: non-alcoholic placebo alcohol
|
|---|---|---|---|---|
|
Profile of Mood States - Fatigue Scale
|
2.2 units on a scale
Standard Deviation 2.1
|
1.6 units on a scale
Standard Deviation 1.4
|
2.0 units on a scale
Standard Deviation 1.6
|
1.5 units on a scale
Standard Deviation 1.4
|
Adverse Events
ALC and NAL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo ALC and NAL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill and ALC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill and Placebo ALC
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