Trial Outcomes & Findings for An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence (NCT NCT00667875)
NCT ID: NCT00667875
Last Updated: 2017-09-29
Results Overview
Standard drinks per drinking day
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
16-week treatment period
Results posted on
2017-09-29
Participant Flow
Subjects were recruited from the community in response to advertising in local papers, and radio
Subjects were to remain abstinent for 4 days prior to starting treatment with the randomly assigned study drug.
Participant milestones
| Measure |
1 Placebo
Placebo : placebo
|
2 Naltrexone
Naltrexone
Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)
|
3 Naltrexone Plus Aripiprazole
Naltrexone + Aripiprazole
Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
21
|
|
Overall Study
Subjects Included in Analysisd
|
20
|
21
|
19
|
|
Overall Study
COMPLETED
|
13
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
13
|
Reasons for withdrawal
| Measure |
1 Placebo
Placebo : placebo
|
2 Naltrexone
Naltrexone
Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)
|
3 Naltrexone Plus Aripiprazole
Naltrexone + Aripiprazole
Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
10
|
9
|
7
|
Baseline Characteristics
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
Baseline characteristics by cohort
| Measure |
1 Placebo
n=23 Participants
Placebo : placebo
|
2 Naltrexone
n=21 Participants
Naltrexone
Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)
|
3 Naltrexone Plus Aripiprazole
n=21 Participants
Naltrexone + Aripiprazole
Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16-week treatment periodStandard drinks per drinking day
Outcome measures
| Measure |
Inactive Placebo
n=20 Participants
Inactive placebo naltrexone + inactive placebo Aripiprazole
|
Naltrexone and Inactive Placebo Aripiprazole
n=21 Participants
Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
|
Naltrexone + Aripiprazole
n=19 Participants
Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
Drinks Per Drinking Day
|
7.2 drinks per drinking day
Standard Deviation 7.3
|
7.8 drinks per drinking day
Standard Deviation 6.6
|
5.2 drinks per drinking day
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: 16 weekspercent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)
Outcome measures
| Measure |
Inactive Placebo
n=20 Participants
Inactive placebo naltrexone + inactive placebo Aripiprazole
|
Naltrexone and Inactive Placebo Aripiprazole
n=21 Participants
Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
|
Naltrexone + Aripiprazole
n=19 Participants
Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
Percent Heavy Drinking Days
|
10.54 percent of days
Standard Deviation 20.0
|
16.7 percent of days
Standard Deviation 19.9
|
7.34 percent of days
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: 16-weekCompliance with medication as determined by pill counts
Outcome measures
| Measure |
Inactive Placebo
n=20 Participants
Inactive placebo naltrexone + inactive placebo Aripiprazole
|
Naltrexone and Inactive Placebo Aripiprazole
n=21 Participants
Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
|
Naltrexone + Aripiprazole
n=19 Participants
Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
Pill Counts During Treatment
Percent aripiprazole or aripiprazole placebo taken
|
96.4 Percent of pills taken
Standard Deviation 6.5
|
97.0 Percent of pills taken
Standard Deviation 4.7
|
84.2 Percent of pills taken
Standard Deviation 25.2
|
|
Pill Counts During Treatment
Percent naltrexone or naltrexone placebo taken
|
96.8 Percent of pills taken
Standard Deviation 5.9
|
96.9 Percent of pills taken
Standard Deviation 4.2
|
86.4 Percent of pills taken
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: 16 weeks treatment trialRiboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime
Outcome measures
| Measure |
Inactive Placebo
n=20 Participants
Inactive placebo naltrexone + inactive placebo Aripiprazole
|
Naltrexone and Inactive Placebo Aripiprazole
n=21 Participants
Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
|
Naltrexone + Aripiprazole
n=19 Participants
Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance
|
74.9 Percent of riboflavin positive samples
Standard Deviation 33.7
|
85.1 Percent of riboflavin positive samples
Standard Deviation 18.5
|
62.1 Percent of riboflavin positive samples
Standard Deviation 30.9
|
Adverse Events
Inactive Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Naltrexone and Inactive Placebo Aripiprazole
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Naltrexone + Aripiprazole
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inactive Placebo
n=23 participants at risk
Inactive placebo naltrexone + inactive placebo Aripiprazole
|
Naltrexone and Inactive Placebo Aripiprazole
n=21 participants at risk
Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
|
Naltrexone + Aripiprazole
n=21 participants at risk
Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
|
|---|---|---|---|
|
General disorders
Dizziness
|
26.1%
6/23 • Number of events 11 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
42.9%
9/21 • Number of events 17 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
47.6%
10/21 • Number of events 21 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
26.1%
6/23 • Number of events 6 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
57.1%
12/21 • Number of events 20 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
47.6%
10/21 • Number of events 14 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
General disorders
Headache
|
60.9%
14/23 • Number of events 34 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
47.6%
10/21 • Number of events 15 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
42.9%
9/21 • Number of events 20 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
General disorders
Fatigue or tiredness
|
43.5%
10/23 • Number of events 37 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
76.2%
16/21 • Number of events 39 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
57.1%
12/21 • Number of events 20 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
Gastrointestinal disorders
Diarrhea
|
17.4%
4/23 • Number of events 7 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
38.1%
8/21 • Number of events 15 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
14.3%
3/21 • Number of events 5 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
Nervous system disorders
Nervousness/anxiety
|
52.2%
12/23 • Number of events 45 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
61.9%
13/21 • Number of events 34 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
52.4%
11/21 • Number of events 27 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
General disorders
Insomnia
|
39.1%
9/23 • Number of events 40 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
57.1%
12/21 • Number of events 33 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
42.9%
9/21 • Number of events 28 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
|
General disorders
Somnolence
|
30.4%
7/23 • Number of events 9 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
42.9%
9/21 • Number of events 17 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
23.8%
5/21 • Number of events 8 • Adverse event data were collected over 16 weeks following randomization visit.
The SAFTEE was used to collect this data. Psychopharmacol Bull. 1986;22(2):343-81
|
Additional Information
Raymond F. Anton, MD
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