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Completed

NCT Number: NCT03012815

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.

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Key information

Conditions

Alcohol Withdrawal Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Gabapentin administered as a taper

Other names: Neurontin

Benzodiazepines

Drug

Benzodiazepines administered using a symptoms triggered protocol

Other names: lorazepam, chlordiazepoxide

Divalproex Sodium

Drug

Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)

Other names: Depakote

Primary outcomes

  1. Mean Length of Hospital Stay

    Time frame: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.

    The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are <10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity

Secondary outcomes

  1. Number of Participants With Delirium Tremens (DT)

    Time frame: During hospitalization (up to 240 hours)

    The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge).

  2. Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale

    Time frame: 4 days

    CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity

  3. Change in Sleepiness as Assessed by the Epworth Sleepiness Scale

    Time frame: Baseline and 2 days

    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness.

  4. Mean Total Benzodiazepine Use

    Time frame: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.

    The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg.

  5. Number of Participants Experiencing Seizure

    Time frame: During hospitalization (up to 240 hours).

    The number of subjects who developed seizure during their hospitalization.

  6. Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale

    Time frame: Baseline and 2 days

    PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol)

  7. Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale

    Time frame: Baseline and 2 days

    GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2017
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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