Trial Outcomes & Findings for Gabapentin for Alcohol Withdrawal Syndrome (NCT NCT03012815)
NCT ID: NCT03012815
Last Updated: 2022-03-24
Results Overview
The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are \<10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores \> 8 represent more withdrawal symptoms and greater severity
COMPLETED
PHASE4
88 participants
Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.
2022-03-24
Participant Flow
Participant milestones
| Measure |
Gabapentin
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
42
|
|
Overall Study
COMPLETED
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Gabapentin
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gabapentin
n=46 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 13.51 • n=46 Participants
|
46.7 years
STANDARD_DEVIATION 11.88 • n=42 Participants
|
47.6 years
STANDARD_DEVIATION 12.72 • n=88 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=46 Participants
|
9 Participants
n=42 Participants
|
23 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=46 Participants
|
33 Participants
n=42 Participants
|
65 Participants
n=88 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
42 participants
n=42 Participants
|
88 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are \<10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores \> 8 represent more withdrawal symptoms and greater severity
Outcome measures
| Measure |
Gabapentin
n=46 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Mean Length of Hospital Stay
|
44.91 hours
Standard Deviation 12.17
|
50.50 hours
Standard Deviation 25.07
|
SECONDARY outcome
Timeframe: During hospitalization (up to 240 hours)The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge).
Outcome measures
| Measure |
Gabapentin
n=46 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Number of Participants With Delirium Tremens (DT)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 daysCIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores \> 8 represent more withdrawal symptoms and greater severity
Outcome measures
| Measure |
Gabapentin
n=46 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale
|
13.15 score on a scale
Standard Deviation 5.70
|
12.81 score on a scale
Standard Deviation 6.94
|
SECONDARY outcome
Timeframe: Baseline and 2 daysPopulation: Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later
The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness.
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=10 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Change in Sleepiness as Assessed by the Epworth Sleepiness Scale
|
-0.03 score on a scale
Standard Deviation 4.02
|
0.07 score on a scale
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg.
Outcome measures
| Measure |
Gabapentin
n=46 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Mean Total Benzodiazepine Use
|
5.2 milligrams
Standard Deviation 6.8
|
10.8 milligrams
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: During hospitalization (up to 240 hours).The number of subjects who developed seizure during their hospitalization.
Outcome measures
| Measure |
Gabapentin
n=46 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Number of Participants Experiencing Seizure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 2 daysPopulation: Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later
PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol)
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=10 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale
|
-8.12 score on a scale
Standard Deviation 9.15
|
-8.45 score on a scale
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Baseline and 2 daysPopulation: Those patients who completed baseline questionnaire and follow-up questionnaire 48 hours later
GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety.
Outcome measures
| Measure |
Gabapentin
n=19 Participants
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=10 Participants
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
|
-0.07 score on a scale
Standard Deviation 4.80
|
-3.79 score on a scale
Standard Deviation 6.08
|
Adverse Events
Gabapentin
Benzodiazepine
Serious adverse events
| Measure |
Gabapentin
n=46 participants at risk
Patients received gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Still underwent CIWA-Ar scoring but did not receive a benzodiazepine.
Gabapentin: Gabapentin administered as a taper
Divalproex Sodium: Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
|
Benzodiazepine
n=42 participants at risk
Patients received a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Benzodiazepines: Benzodiazepines administered using a symptoms triggered protocol
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
2.2%
1/46 • Number of events 1 • Adverse events were collected during the patient's hospitalization (from admission to discharge, up to 240 hours).
|
0.00%
0/42 • Adverse events were collected during the patient's hospitalization (from admission to discharge, up to 240 hours).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place