Gabapentin for Alcohol Withdrawal Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | February 1, 2017 |
| End Date: | December 1, 2021 |
A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome
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.
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.
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.
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.
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.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-255-8716
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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