Trial Outcomes & Findings for Gabapentin for Abstinence Initiation in Alcohol Dependence (NCT NCT01141049)
NCT ID: NCT01141049
Last Updated: 2019-04-24
Results Overview
percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
40 participants
Primary outcome timeframe
assesed over 8 weeks, presented for week 8 of trial
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
Gabapentin
Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
|
Placebo
Placebo capsules will be administered TID.
Placebo: Placebo, TID
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin for Abstinence Initiation in Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Gabapentin
n=19 Participants
Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
|
Placebo
n=21 Participants
Placebo capsules will be administered TID.
Placebo: Placebo, TID
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assesed over 8 weeks, presented for week 8 of trialpercent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
|
Placebo
n=21 Participants
Placebo capsules will be administered TID.
Placebo: Placebo, TID
|
|---|---|---|
|
Percent of Heavy Drinking Days Per Week
|
22.5 percent of heavy drinking days
Standard Deviation 34.0
|
53.9 percent of heavy drinking days
Standard Deviation 44.0
|
SECONDARY outcome
Timeframe: assessed for up to 8 weeks, presented at week 8 of trialDuring the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
|
Placebo
n=21 Participants
Placebo capsules will be administered TID.
Placebo: Placebo, TID
|
|---|---|---|
|
Percent Days of Abstinence From Alcohol
|
50 percent of days abstinent
Standard Deviation 37
|
27.5 percent of days abstinent
Standard Deviation 38
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=19 participants at risk
Gabapentin will be titrated over a 7-day period to the dose target or the maximum tolerated dose. The maximum dose will be 1200mg TID. Participants must be able to tolerate and comply with at least 400 mg daily.
Gabapentin: During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
|
Placebo
n=21 participants at risk
Placebo capsules will be administered TID.
Placebo: Placebo, TID
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
5.3%
1/19 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
anxiety
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
Gastrointestinal disorders
appetite change
|
5.3%
1/19 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
0.00%
0/21 • during 8 weeks of trial or participant's length of participation
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
Gastrointestinal disorders
diarrhea
|
5.3%
1/19 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
0.00%
0/21 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
dizziness
|
10.5%
2/19 • Number of events 2 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
dry mouth
|
15.8%
3/19 • Number of events 3 • during 8 weeks of trial or participant's length of participation
|
19.0%
4/21 • Number of events 4 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
headache
|
10.5%
2/19 • Number of events 2 • during 8 weeks of trial or participant's length of participation
|
9.5%
2/21 • Number of events 2 • during 8 weeks of trial or participant's length of participation
|
|
Gastrointestinal disorders
gi upset
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
insomnia
|
5.3%
1/19 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
0.00%
0/21 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
libido changes
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
muscle pain/weakness
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/19 • during 8 weeks of trial or participant's length of participation
|
9.5%
2/21 • Number of events 2 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
somnolence
|
10.5%
2/19 • Number of events 2 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
|
General disorders
fatigue
|
10.5%
2/19 • Number of events 2 • during 8 weeks of trial or participant's length of participation
|
23.8%
5/21 • Number of events 5 • during 8 weeks of trial or participant's length of participation
|
|
Gastrointestinal disorders
vomiting
|
5.3%
1/19 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
4.8%
1/21 • Number of events 1 • during 8 weeks of trial or participant's length of participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place