Gabapentin for Alcohol Withdrawal Syndrome

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Chlordiazepoxide; Ethanol; Gabapentin; gamma-Aminobutyric Acid; Lorazepam; Valproic Acid

Criteria

Inclusion criteria

1. Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score >4.

2. Adults age 18 or older.

3. Sufficient understanding of English.

4. Hospitalized on Hospital Internal Medicine or Generose.

Exclusion criteria

1. Severe renal impairment (estimated CrCl < 30).

2. Intensive Care Unit (ICU) level of care.

3. Not responsive due to alcohol intoxication or withdrawal.

4. Already taking gabapentin more than 300 mg three times a day.

5. Prescribed pregabalin.

6. Primary seizure disorder.

7. Acute benzodiazepine withdrawal.

8. 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.

9. Concurrent anticonvulsant medications for psychiatric indications (e.g. bipolar disorder) will be allowed.

10. Pregnancy.

11. Involuntary legal status (e.g., on court commitment).

12. Patients admitted greater than 12 hours prior to potential enrollment.

13. Patients receiving therapeutic dose of gabapentin (rather than continuation of home dose) prior to enrollment.