Phase 4
N=88
Gabapentin for Alcohol Withdrawal Syndrome
Alcohol Withdrawal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03012815 ↗Enrolled (actual)
88
Serious AEs
1.1%
Results posted
Mar 2022
Primary outcome: Primary: Mean Length of Hospital Stay — 44.91; 50.50 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin (Drug); Benzodiazepines (Drug); Divalproex Sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Length of Hospital Stay |
44.91; 50.50 | — |
| SECONDARY Number of Participants With Delirium Tremens (DT) |
0; 0 | — |
| SECONDARY Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale |
13.15; 12.81 | — |
| SECONDARY Change in Sleepiness as Assessed by the Epworth Sleepiness Scale |
-0.03; 0.07 | — |
| SECONDARY Mean Total Benzodiazepine Use |
5.2; 10.8 | — |
| SECONDARY Number of Participants Experiencing Seizure |
0; 0 | — |
| SECONDARY Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale |
-8.12; -8.45 | — |
| SECONDARY Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale |
-0.07; -3.79 | — |
Summary
The current "gold-standard" for the management of alcohol withdrawal syndrome (AWS) is symptom-triggered administration of benzodiazepines. This method of treatment has several drawbacks that have been described in the literature. Thus benzodiazepine sparing agents have been evaluated for use in AWS. One of these agents that has not only shown benefit for AWS but also benefits on complete abstinence, reducing a return to heavy drinking, and cravings is gabapentin. In clinical practice at Mayo Clinic gabapentin is used for this purpose. Due to the limited reports of the safety and efficacy of a protocol involving gabapentin for AWS, a study to compare gabapentin to symptom-triggered lorazepam will be completed.
Eligibility Criteria
Inclusion criteria
- Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score >4.
- Adults age 18 or older.
- Sufficient understanding of English.
- Hospitalized on Hospital Internal Medicine or Generose.
Exclusion criteria
- Severe renal impairment (estimated CrCl < 30).
- Intensive Care Unit (ICU) level of care.
- Not responsive due to alcohol intoxication or withdrawal.
- Already taking gabapentin more than 300 mg three times a day.
- Prescribed pregabalin.
- Primary seizure disorder.
- Acute benzodiazepine withdrawal.
- Concurrent substance use disorders (such as opioid use disorder, stimulant use disorder) if the disorder is assessed to be clinically significant. Cannabis use disorder will be allowed.
- Concurrent anticonvulsant medications for psychiatric indications (e.g. bipolar disorder) will be allowed.
- Pregnancy.
- Involuntary legal status (e.g., on court commitment).
- Patients admitted greater than 12 hours prior to potential enrollment.
- Patients receiving therapeutic dose of gabapentin (rather than continuation of home dose) prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT03012815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.