Gabapentin for Alcohol Withdrawal Syndrome

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Alcohol Withdrawal Syndrome

Treatments: Drug: Benzodiazepines; Drug: Gabapentin; Drug: Divalproex Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03012815

16-008712

Details and patient eligibility

About

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.

Full description

The current "gold-standard" for the management of alcohol withdrawal syndrome is symptom-triggered administration of benzodiazepines. Benzodiazepines and use of a symptom-triggered approach has several drawbacks such as over administration of medication due to many subjective patient reported symptoms. Benzodiazepines may contribute to a drug-induced delirium or high dosage may necessitate transfer to an ICU setting. Abrupt withdrawal of benzodiazepines also contribute to cravings, rebound insomnia, and anxiety that have been shown to increase the risk of a return drinking.

Clinical use of gabapentin for alcohol withdrawal has been presented by Maldonado at Stanford University Hospitals. (Academy of Psychosomatic Medicine Annual Meeting, 2013-2015) At Mayo Clinic, the Psychiatry Consultation-Liaison hospital service has been recommending the use of a modified gabapentin protocol since January 2015, which has been clinically accepted on medical, surgical, and psychiatric hospital services. The purpose of this research is to investigate the reactive benzodiazepine versus proactive gabapentin approaches to AWS in a prospective, randomized, open-label study.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Gabapentin

Experimental group

Description:

Patients will receive gabapentin taper over 9 days with the option to add divalproex for patients who have a history of seizures or severe withdrawal. Will still undergo CIWA-Ar scoring but will not be administered a benzodiazepine.

Treatment:

Drug: Divalproex Sodium

Drug: Gabapentin

Benzodiazepine

Active Comparator group

Description:

Patients will receive a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.

Treatment:

Drug: Benzodiazepines