Trial Outcomes & Findings for Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism (NCT NCT00920829)
NCT ID: NCT00920829
Last Updated: 2018-07-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
358 participants
Primary outcome timeframe
Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)
Results posted on
2018-07-10
Participant Flow
358 Subjects were recruited via media advertisements and clinical referrals and 355 provided a blood sample for A118G genotyping.
A118G genotyping was performed for 355 of these, 259 were A/A (Asn40) allele and 96 were any G (asp). Of the 259 Asn40 subjects, 89 were selected to participate 5 met exclusion criteria and 7 were lost or declined. Of the 96 Asp subjects, 9 met exclusion; 12 were lost or declined.
Participant milestones
| Measure |
A118G A/A With Naltrexone
Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule
|
A118G A/A With Placebo
Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks
Placebo: placebo
|
A118G Any G With Naltrexone
Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule
|
A118G Any G With Placebo
Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Placebo: placebo
|
|---|---|---|---|---|
|
Allocation
STARTED
|
38
|
39
|
38
|
37
|
|
Allocation
COMPLETED
|
35
|
38
|
38
|
35
|
|
Allocation
NOT COMPLETED
|
3
|
1
|
0
|
2
|
|
Available for Analysis
STARTED
|
35
|
38
|
38
|
35
|
|
Available for Analysis
COMPLETED
|
27
|
27
|
28
|
24
|
|
Available for Analysis
NOT COMPLETED
|
8
|
11
|
10
|
11
|
Reasons for withdrawal
| Measure |
A118G A/A With Naltrexone
Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule
|
A118G A/A With Placebo
Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks
Placebo: placebo
|
A118G Any G With Naltrexone
Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone Hydrochloride 50 MG: Naltrexone 25 or 50 mg per tiration schedule
|
A118G Any G With Placebo
Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Placebo: placebo
|
|---|---|---|---|---|
|
Allocation
No post randomization data
|
3
|
1
|
0
|
2
|
|
Available for Analysis
Withdrawal by Subject
|
6
|
6
|
6
|
10
|
|
Available for Analysis
Required Medical Treatment
|
0
|
1
|
2
|
0
|
|
Available for Analysis
Adverse Event
|
1
|
2
|
1
|
0
|
|
Available for Analysis
Death
|
1
|
0
|
0
|
0
|
|
Available for Analysis
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Available for Analysis
Required more treatment
|
0
|
2
|
0
|
1
|
Baseline Characteristics
Genetic and Brain Mechanisms of Naltrexone's Treatment Efficacy for Alcoholism
Baseline characteristics by cohort
| Measure |
A118G A/A With Naltrexone
n=35 Participants
Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule
|
A118G A/A With Placebo
n=38 Participants
Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks
Placebo: placebo
|
A118G Any G With Naltrexone
n=38 Participants
Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule
|
A118G Any G With Placebo
n=35 Participants
Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Placebo: placebo
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
46.3 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
50.3 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
49.7 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 10.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
101 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
144 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)Outcome measures
| Measure |
A118G A/A With Naltrexone
n=35 Participants
Individuals with the OPRM1 genotype Asn40 are given naltrexone 50 mg after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule
|
A118G A/A With Placebo
n=38 Participants
Individuals with the OPRM1 genotype Asn40 are given Placebo for 16 weeks with Medication Management in 16 weeks
Placebo: placebo
|
A118G Any G With Naltrexone
n=38 Participants
Individuals with the OPRM1 genotype Any G (Asp) are given naltrexone 50 mg after 2 days of naltrexone 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Naltrexone 50 MG: Naltrexone 25 or 50 mg per titration schedule
|
A118G Any G With Placebo
n=35 Participants
Individuals with the OPRM1 genotype Any G (Asp) are given 50 mg naltrexone after 2 days at 25 mg for 16 weeks with Medication Management 9 visits in 16 weeks
Placebo: placebo
|
|---|---|---|---|---|
|
Percent Heavy Drinking Days by mu Opioid Receptor Gene
Month 1
|
11.0 percentage of days
Standard Error 3.5
|
18.0 percentage of days
Standard Error 3.4
|
11.8 percentage of days
Standard Error 3.4
|
18.7 percentage of days
Standard Error 3.6
|
|
Percent Heavy Drinking Days by mu Opioid Receptor Gene
Month 2
|
11.7 percentage of days
Standard Error 4.5
|
25.8 percentage of days
Standard Error 4.4
|
15.5 percentage of days
Standard Error 4.4
|
19.7 percentage of days
Standard Error 4.5
|
|
Percent Heavy Drinking Days by mu Opioid Receptor Gene
Month 3
|
10.4 percentage of days
Standard Error 4.4
|
23.0 percentage of days
Standard Error 4.3
|
16.9 percentage of days
Standard Error 4.3
|
25.0 percentage of days
Standard Error 4.4
|
|
Percent Heavy Drinking Days by mu Opioid Receptor Gene
Month 4
|
11.4 percentage of days
Standard Error 4.7
|
18.1 percentage of days
Standard Error 4.5
|
18.3 percentage of days
Standard Error 4.5
|
28.7 percentage of days
Standard Error 4.6
|
Adverse Events
Placebo/ASN
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo/ASP
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Naltrexone/ASN
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Naltrexone/ASP
Serious events: 0 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo/ASN
n=38 participants at risk
ASN subjects given placebo
|
Placebo/ASP
n=35 participants at risk
ASP subjects given placebo
|
Naltrexone/ASN
n=35 participants at risk
ASN subjects given naltrexone
|
Naltrexone/ASP
n=38 participants at risk
ASP subjects given naltrexone
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.7%
9/38 • Number of events 9
Number of subjects responding positively to queries in the SAFTEE instrument.
|
25.7%
9/35 • Number of events 14
Number of subjects responding positively to queries in the SAFTEE instrument.
|
62.9%
22/35 • Number of events 27
Number of subjects responding positively to queries in the SAFTEE instrument.
|
34.2%
13/38 • Number of events 26
Number of subjects responding positively to queries in the SAFTEE instrument.
|
|
Gastrointestinal disorders
Diarrhea
|
15.8%
6/38 • Number of events 8
Number of subjects responding positively to queries in the SAFTEE instrument.
|
25.7%
9/35 • Number of events 19
Number of subjects responding positively to queries in the SAFTEE instrument.
|
51.4%
18/35 • Number of events 28
Number of subjects responding positively to queries in the SAFTEE instrument.
|
42.1%
16/38 • Number of events 35
Number of subjects responding positively to queries in the SAFTEE instrument.
|
|
Gastrointestinal disorders
abdominal pain
|
10.5%
4/38 • Number of events 6
Number of subjects responding positively to queries in the SAFTEE instrument.
|
14.3%
5/35 • Number of events 17
Number of subjects responding positively to queries in the SAFTEE instrument.
|
31.4%
11/35 • Number of events 22
Number of subjects responding positively to queries in the SAFTEE instrument.
|
42.1%
16/38 • Number of events 32
Number of subjects responding positively to queries in the SAFTEE instrument.
|
|
General disorders
dizziness
|
15.8%
6/38 • Number of events 7
Number of subjects responding positively to queries in the SAFTEE instrument.
|
25.7%
9/35 • Number of events 21
Number of subjects responding positively to queries in the SAFTEE instrument.
|
40.0%
14/35 • Number of events 26
Number of subjects responding positively to queries in the SAFTEE instrument.
|
36.8%
14/38 • Number of events 24
Number of subjects responding positively to queries in the SAFTEE instrument.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place