Trial Outcomes & Findings for Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability. (NCT NCT00366626)
NCT ID: NCT00366626
Last Updated: 2017-06-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
treatment days 1 - 5
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
Naltrexone
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
45
|
|
Overall Study
COMPLETED
|
38
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.
Baseline characteristics by cohort
| Measure |
Naltrexone
n=38 Participants
|
Placebo
n=45 Participants
|
Total
n=83 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
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 10 • n=5 Participants
|
26 years
STANDARD_DEVIATION 10 • n=7 Participants
|
28 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
45 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: treatment days 1 - 5Population: All subjects who were randomized.
Outcome measures
| Measure |
Naltrexone (asn40asn)
n=19 Participants
Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
|
Naltrexone (asp40)
n=19 Participants
Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
|
Placebo (asn40asn )
n=21 Participants
Subjects with asn40asn OPRM1 SNP who got Placebo during he study
|
Placebo (asp40)
n=24 Participants
Subjects with asp40 OPRM1 SNP who got Placebo during he study
|
|---|---|---|---|---|
|
"Natural" Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period
|
4.7 Drinks per day
Standard Deviation 1.8
|
5.7 Drinks per day
Standard Deviation 3.2
|
6.2 Drinks per day
Standard Deviation 3.4
|
6.3 Drinks per day
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: On day 7 of treatment during limited access alcohol consuption in the bar/laboratoryPopulation: All subjects who were randomized.
Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.
Outcome measures
| Measure |
Naltrexone (asn40asn)
n=19 Participants
Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
|
Naltrexone (asp40)
n=19 Participants
Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
|
Placebo (asn40asn )
n=21 Participants
Subjects with asn40asn OPRM1 SNP who got Placebo during he study
|
Placebo (asp40)
n=24 Participants
Subjects with asp40 OPRM1 SNP who got Placebo during he study
|
|---|---|---|---|---|
|
Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed
|
3.0 Total number of drinks consumed
Standard Deviation 2.9
|
3.8 Total number of drinks consumed
Standard Deviation 3.1
|
3.8 Total number of drinks consumed
Standard Deviation 2.8
|
3.1 Total number of drinks consumed
Standard Deviation 3.3
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Dr. Raymond F. Anton, Distinguished University Professor
Medical University of South Carolina
Phone: 843-792-1226
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place