Trial Outcomes & Findings for Prometa Protocol for Alcohol Dependence (NCT NCT00262639)
NCT ID: NCT00262639
Last Updated: 2019-02-15
Results Overview
percent of subjects completely abstinent during the six week medication study study
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
60 participants
Primary outcome timeframe
6 week trial
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Low CIWA Flumazenil/Gabapentin
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
|
Low CIWAar Placebo
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
|
High CIWAar Placebo
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
|
High CIWAar Flumazenil/Gabapentin
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
26
|
9
|
7
|
|
Overall Study
COMPLETED
|
18
|
26
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prometa Protocol for Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Low CIWAar Placebo
n=18 Participants
|
Low CIWAar Flumazenil/Gabapentin
n=26 Participants
|
High CIWAar Placebo
n=9 Participants
|
High CIWAar Flumazenil/Gabapentin
n=7 Participants
|
Total
n=60 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Age, Categorical
>=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
|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
46.1 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
26 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 week trialpercent of subjects completely abstinent during the six week medication study study
Outcome measures
| Measure |
Low CIWA Flumazenil/Gabapentin
n=18 Participants
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
|
Low CIWAar Placebo
n=26 Participants
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
|
High CIWAar Placebo
n=9 Participants
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
|
High CIWAar Flumazenil/Gabapentin
n=7 Participants
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
|
|---|---|---|---|---|
|
Percent Subjects Completely Abstinent
|
44 percent of participants
|
19 percent of participants
|
33 percent of participants
|
71 percent of participants
|
PRIMARY outcome
Timeframe: Weeks 1 to 6percent days abstinent during treatment
Outcome measures
| Measure |
Low CIWA Flumazenil/Gabapentin
n=18 Participants
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
|
Low CIWAar Placebo
n=26 Participants
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
|
High CIWAar Placebo
n=9 Participants
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
|
High CIWAar Flumazenil/Gabapentin
n=7 Participants
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
|
|---|---|---|---|---|
|
Percent Days Abstinent
|
70.8 percent days
Standard Deviation 24.2
|
86.1 percent days
Standard Deviation 20.7
|
75.9 percent days
Standard Deviation 27
|
95.9 percent days
Standard Deviation 9.7
|
Adverse Events
Low CIWA Flumazenil/Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low CIWAar Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High CIWAar Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High CIWAar Flumazenil/Gabapentin
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
Raymond F. Anton, M.D.
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