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Gabapentin for Alcohol Withdrawal Syndrome

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ClinicalTrials.gov Identifier: NCT03012815
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Ruth E Bates, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Syndrome Drug: Gabapentin Drug: Benzodiazepines Drug: Divalproex Sodium Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
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.
Drug: Gabapentin
Gabapentin administered as a taper
Other Name: Neurontin

Drug: Divalproex Sodium
Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
Other Name: Depakote

Active Comparator: Benzodiazepine
Patients will receive a benzodiazepine if scoring greater than 9 on the CIWA-Ar scale.
Drug: Benzodiazepines
Benzodiazepines administered using a symptoms triggered protocol
Other Names:
  • lorazepam
  • chlordiazepoxide




Primary Outcome Measures :
  1. Length of Stay for Alcohol Withdrawal Syndrome [ Time Frame: Time to discharge or time to CIWA score < 10 for 36 hours ]

Secondary Outcome Measures :
  1. Delirium tremens [ Time Frame: Through study completion, an average 4 days ]
  2. Alcohol withdrawal severity Per CIWA-Ar scale protocol [ Time Frame: Through study completion, an average 4 days ]
  3. Sleepiness as assessed by the Epworth Sleepiness Scale [ Time Frame: At time of enrollment and at discharge, an average of 4 days ]
  4. Total amount of benzodiazepines given [ Time Frame: During length of admission, an average of 4 days; or time to CIWA score < 10 for 36 hours ]
    Total benzodiazepines received by each patient in lorazepam equivalents

  5. Seizure [ Time Frame: Through study completion, an average 4 days ]
    The occurrence (if any) of seizure

  6. Cravings as assessed by the Penn Alcohol Craving Scale [ Time Frame: At time of enrollment and at discharge (an average of 4 days) or time to CIWA score < 10 for 36 hours ]
  7. Anxiety symptoms as measured by the GAD-7 (Generalized Anxiety Disorder-7) [ Time Frame: At time of enrollment and at discharge (an average of 4 days) or time to CIWA score < 10 for 36 hours ]
  8. Depressive symptoms as measured by the PHQ-9 (Patient Health Questionnaire-9) [ Time Frame: At time of enrollment and at discharge (an average of 4 days) or time to CIWA score < 10 for 36 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012815


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ruth E Bates, MD Mayo Clinic
Additional Information:
Publications:
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Responsible Party: Ruth E Bates, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03012815    
Other Study ID Numbers: 16-008712
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruth E Bates, Mayo Clinic:
gabapentin
Alcohol Withdrawal Syndrome
benzodiazepine
symptom-triggered
Additional relevant MeSH terms:
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Syndrome
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Chlordiazepoxide
Gabapentin
Lorazepam
Valproic Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
GABA Modulators