Alcohol DependencePhase 4PAVENCT03235531
Assessment of Valproate on Ethanol Withdrawal
A Phase 4 study testing Valproate and Lorazepam in people with Alcohol Dependence and Alcohol Withdrawal Syndrome, run by CAMC Health System at 2 sites in United States.
Trial summary
Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is collection of symptoms that can range from anxiety and restlessness to seizures, delirium and even death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Alcohol Withdrawal Syndrome, Trauma
- What is being tested?
- Valproate and Lorazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2017to 25 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to Trauma Services
- Heavy drinkers based on social history
- Men <65 years: > 4 drinks per day or 14 per week
- Women: > 3 drinks per day or 7 drinks per week
- All adults >65 years: > 3 drinks per day or 7 drinks per week
- Moderate or severe alcohol use disorder based on social history and DSM-5 criteria
- Moderate: Presence of 4-5 symptoms based on social history
- Severe: Presence of 6 symptoms based on social history
Who cannot join
- Intubated patients
- Glasgow Coma Score <8
- Grade IV liver laceration or greater
- Child-Pugh Class B or greater, history of cirrhosis, or cirrhosis identified by radiographic imaging upon admission
- Transaminase (AST/ALT) elevation of ≥ 2x normal
- Anticipated admission less than 72 hours
Show all 12Show fewer
- Levetiracetam administration for seizure prophylaxis secondary to a traumatic brain injury
- Patient with VPA as home medication
- Known allergy to VPA
- Patients with pre-existing blood dyscrasias, i.e. thrombocytopenia (platelet count < 50,000, etc)
- Inability to obtain social history from patient, surrogate, family member or an individual deemed to be knowledgeable about the patient's social history
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Charleston Area Medical Center, General Hospital, Level 1 Trauma Center
Charleston, West Virginia, 25301
Charleston Area Medical Center
Charleston, West Virginia, 25304
About this study
Official title: Prospective Assessment of Valproate on Ethanol Withdrawal
Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is collection of symptoms that can range from anxiety and restlessness to seizures, delirium and even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these medications have proven efficacy, they can also have negative side effects which may affect recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS symptoms, thus ameliorating or preventing the need for BZD administration. This trial will study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.
Read the detailed description
Alcohol use disorder is a common comorbidity among trauma patients. This pre-existing condition is associated with Alcohol Withdrawal Syndrome (AWS) and frequently complicates the management of this patient population. Current treatment and/or prevention of AWS includes the administration of sedatives (benzodiazepines [BZD]) in response to the manifestation AWS symptoms. This manifestation is indicated by monitoring patients using the Clinical Institute Withdrawal Assessment (CIWA) tool. Benzodiazepines elicit an effect on AWS via mediation of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Benzodiazepines, however, have the potential to promote multiple negative effects in the acute care setting, including increased incidence of delirium, hospital stay, mortality, and the potential for decreased long-term cognitive function. The antiepileptic medication valproate (VPA) also has GABA activity in the brain, but may be less likely to promote the negative effects associated with BZDs. Currently, previous experience with this agent for the prevention of AWS is limited to two small studies. In these studies VPA was shown to decrease symptoms of AWS as indicated by patients' CIWA scores. Therefore, VPA could serve as an efficacious adjuvant therapy for the prevention of AWS. The aim of this study is to determine whether VPA will decrease the use of BZD in patients who are receiving symptom-based preventative therapy via CIWA monitoring. The hypothesis is that VPA will decrease the utilization of symptom-based lorazepam administration in patients who are determined to be at risk of alcohol withdrawal due to routine consumption of alcohol.
The purpose of this study is to determine if prophylactic VPA for the prevention of alcohol withdrawal syndrome can decrease symptom-triggered use of benzodiazepines in patients monitored for alcohol withdrawal syndrome with the CIWA.
The Primary objective of this study is to determine if prophylactic VPA acid is associated with decreased lorazepam use in patients monitored for alcohol withdrawal syndrome with the CIWA.
Secondary objectives are:
To evaluate the difference between comparator arms with respect to:
- CIWA scores between patients with and without VPA prophylaxis
- Hospital and Intensive Care Unit (ICU) length of stay
- In-hospital mortality
- VPA acid associated side effects (e.g. thrombocytopenia, transaminitis, pancreatitis)
This will be single-center prospective, randomized study, enrolling trauma patients with a history of alcohol consumption admitted to a Level 1 trauma center. Patients included in this study will receive standard therapies for AWS practiced at study institution which include monitoring of withdrawal symptoms and the administration of BZDs (lorazepam) based on CIWA monitoring.
Following informed consent, patients will be randomized to receive CIWA protocol monitoring/BZD or CIWA protocol monitoring/BZD and VPA. Therefore, patients that meet the inclusion criteria will be separated into two study groups to compare outcomes:
- Treatment Group: Patients treated with CIWA protocol/BZD and VPA
- Control Group: Patients treated with CIWA protocol/BZD only.
- Conditions
- Alcohol Dependence, Alcohol Withdrawal Syndrome, Trauma, Heavy Drinking, Alcohol Use Disorder
- Being tested
- Valproate, Lorazepam
- Keywords
- alcohol withdrawal syndrome, trauma, alcohol use disorder, alcohol, lorazepam, benzodiazepine, valproate
- Medical subject headings
- Alcoholism, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValproateDrug
Valproate is an anti-epileptic medication that can influence the chemical changes in the brain that result from alcohol withdrawal syndrome (AWS) via three mechanisms of action: (1) an increase in GABA activity, (2) inhibition of glutamate binding to NMDA, and (3) restoration of the balance between dopamine and acetylcholine activity. VPA may be effective in the prevention of AWS, and could serve as efficacious adjuvant to traditional benzodiazepine (BZD) therapy for AWS, both decreasing symptoms of AWS and decreasing the use of BZDs.
LorazepamDrug
Lorazepam is a benzodiazepine used to treat symptoms of AWS. Standard of care at CAMC is monitoring by CIWA tool and administration of lorazepam according to CIWA score.
| Study group | Role | What they receive |
|---|---|---|
| CIWA Protocol/BZD and Valproate | Experimental | 1. Interventions to decrease symptoms of AWS will be made based on the CIWA tool.
* CIWA Score 9-14: 1 mg IV push lorazepam
* CIWA Score >15: 2 mg IV push lorazepam
2. Patients who have a known history of alcohol withdrawal seizures or who have received greater than 4 mg IV lorazepam per CIWA protocol will be placed on a scheduled lorazepam regimen, 1 mg every 6 hours. The primary managing service may increase the scheduled lorazepam regimen above 1mg every 6 hours if needed to control withdrawal symptoms. Scheduled lorazepam will be discontinued or de-escalated following a 24-hour period in which no additional lorazepam was received per CIWA protocol.
3. The treatment group will also receive scheduled valproate (VPA), 15 mg/kg divided over 4 doses, rounded up to the nearest increment of 50mg (i.e. a 70 kg person would be administered 300 mg IV VPA every 6 hours) for 96 hours. Receives: Drug: Valproate; Drug: Lorazepam |
| CIWA Protocol Only | Active comparator | 1. Interventions to decrease symptoms of AWS will be made based on the CIWA tool
* CIWA Score 9-14: 1 mg IV push lorazepam
* CIWA Score >15: 2 mg IV push lorazepam
2. Patients who have a known history of alcohol withdrawal seizures or who have received greater than 4 mg IV lorazepam per CIWA protocol will be placed on a scheduled lorazepam regimen, 1 mg every 6 hours. The primary managing service may increase the scheduled lorazepam regimen above 1mg every 6 hours if needed to control withdrawal symptoms. Scheduled lorazepam will be discontinued or de-escalated following a 24-hour period in which no additional lorazepam was received per CIWA protocol. Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lorazepam use in patient monitored with CIWA
Amount of lorazepam administration in response to CIWA score
Measured: Time between CIWA initiation and discontinuation for up to 3 weeks
Secondary outcomes (5)
CIWA score
CIWA is a ten item scale used in the assessment and management of alcohol withdrawal.
Measured: During patient hospital stay for up to 6 months
Hospital Length of Stay
Date of admission to date of discharge from the hospital
Measured: During patient hospital stay for up to 6 months
Intensive Care Unit Length of Stay
Date of admission to date of discharge from the Intensive Care Unit
Measured: During patient Intensive Care Unit stay for up to 6 months
In-hospital Mortality
Number of deaths
Measured: During patient hospital stay for up to 6 months
Valproate associated side effects
Known side effects associated with valproate use, such as thrombocytopenia, transaminitis, pancreatitis, and hyperammonemia
Measured: During patient hospital stay for up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start11 Jul 2017
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Why it stopped: PI left site without transferring study to another PI. Study expired and was not renewed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audis Bethea, PharmD, BCPS, Principal investigator, Charleston Area Medical Center Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235531
- Sponsor's protocol ID
- 17-336
- Acronym
- PAVE
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2017
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eastes LE. Alcohol withdrawal syndrome in trauma patients: a review. J Emerg Nurs. 2010 Sep;36(5):507-9. doi: 10.1016/j.jen.2010.05.011. Epub 2010 Aug 5. No abstract available.
PubMed 20837230Craft PP, Foil MB, Cunningham PR, Patselas PC, Long-Snyder BM, Collier MS. Intravenous ethanol for alcohol detoxification in trauma patients. South Med J. 1994 Jan;87(1):47-54. doi: 10.1097/00007611-199401000-00011.
PubMed 8284718Makic MB. Alcohol Withdrawal Syndrome. J Perianesth Nurs. 2017 Apr;32(2):140-141. doi: 10.1016/j.jopan.2017.01.007. No abstract available.
PubMed 28343640Foy A, Kay J. The incidence of alcohol-related problems and the risk of alcohol withdrawal in a general hospital population. Drug Alcohol Rev. 1995;14(1):49-54. doi: 10.1080/09595239500185051.
PubMed 16203295Spies C, Tonnesen H, Andreasson S, Helander A, Conigrave K. Perioperative morbidity and mortality in chronic alcoholic patients. Alcohol Clin Exp Res. 2001 May;25(5 Suppl ISBRA):164S-170S. doi: 10.1097/00000374-200105051-00028.
PubMed 11391067Tsai G, Gastfriend DR, Coyle JT. The glutamatergic basis of human alcoholism. Am J Psychiatry. 1995 Mar;152(3):332-40. doi: 10.1176/ajp.152.3.332.
PubMed 7864257Tsai G, Coyle JT. The role of glutamatergic neurotransmission in the pathophysiology of alcoholism. Annu Rev Med. 1998;49:173-84. doi: 10.1146/annurev.med.49.1.173.
PubMed 9509257McKeon A, Frye MA, Delanty N. The alcohol withdrawal syndrome. J Neurol Neurosurg Psychiatry. 2008 Aug;79(8):854-62. doi: 10.1136/jnnp.2007.128322. Epub 2007 Nov 6.
PubMed 17986499Amato L, Minozzi S, Davoli M. Efficacy and safety of pharmacological interventions for the treatment of the Alcohol Withdrawal Syndrome. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD008537. doi: 10.1002/14651858.CD008537.pub2.
PubMed 21678378Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. doi: 10.1056/NEJMra020617. No abstract available.
PubMed 12724485Maldonado JR. Delirium in the acute care setting: characteristics, diagnosis and treatment. Crit Care Clin. 2008 Oct;24(4):657-722, vii. doi: 10.1016/j.ccc.2008.05.008.
PubMed 18929939Clegg A, Young JB. Which medications to avoid in people at risk of delirium: a systematic review. Age Ageing. 2011 Jan;40(1):23-9. doi: 10.1093/ageing/afq140. Epub 2010 Nov 9.
PubMed 21068014Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
PubMed 18495054Saitz R, Mayo-Smith MF, Roberts MS, Redmond HA, Bernard DR, Calkins DR. Individualized treatment for alcohol withdrawal. A randomized double-blind controlled trial. JAMA. 1994 Aug 17;272(7):519-23.
PubMed 8046805Eyer F, Schreckenberg M, Hecht D, Adorjan K, Schuster T, Felgenhauer N, Pfab R, Strubel T, Zilker T. Carbamazepine and valproate as adjuncts in the treatment of alcohol withdrawal syndrome: a retrospective cohort study. Alcohol Alcohol. 2011 Mar-Apr;46(2):177-84. doi: 10.1093/alcalc/agr005.
PubMed 21339186
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Valproate on Ethanol Withdrawal
- ClinicalTrials.gov ID
- NCT03235531
- Acronym / sponsor ID
- PAVE / 17-336
- Conditions
- Alcohol Dependence, Alcohol Withdrawal Syndrome, Trauma, Heavy Drinking, Alcohol Use Disorder
- Keywords
- alcohol withdrawal syndrome, trauma, alcohol use disorder, alcohol, lorazepam, benzodiazepine, valproate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left site without transferring study to another PI. Study expired and was not renewed.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is collection of symptoms that can range from anxiety and restlessness to seizures, delirium and even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these medications have proven efficacy, they can also have negative side effects which may affect recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS symptoms, thus ameliorating or preventing the need for BZD administration. This trial will study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.
Detailed description
Alcohol use disorder is a common comorbidity among trauma patients. This pre-existing condition is associated with Alcohol Withdrawal Syndrome (AWS) and frequently complicates the management of this patient population. Current treatment and/or prevention of AWS includes the administration of sedatives (benzodiazepines [BZD]) in response to the manifestation AWS symptoms. This manifestation is indicated by monitoring patients using the Clinical Institute Withdrawal Assessment (CIWA) tool. Benzodiazepines elicit an effect on AWS via mediation of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Benzodiazepines, however, have the potential to promote multiple negative effects in the acute care setting, including increased incidence of delirium, hospital stay, mortality, and the potential for decreased long-term cognitive function. The antiepileptic medication valproate (VPA) also has GABA activity in the brain, but may be less likely to promote the negative effects associated with BZDs. Currently, previous experience with this agent for the prevention of AWS is limited to two small studies. In these studies VPA was shown to decrease symptoms of AWS as indicated by patients' CIWA scores. Therefore, VPA could serve as an efficacious adjuvant therapy for the prevention of AWS. The aim of this study is to determine whether VPA will decrease the use of BZD in patients who are receiving symptom-based preventative therapy via CIWA monitoring. The hypothesis is that VPA will decrease the utilization of symptom-based lorazepam administration in patients who are determined to be at risk of alcohol withdrawal due to routine consumption of alcohol.
The purpose of this study is to determine if prophylactic VPA for the prevention of alcohol withdrawal syndrome can decrease symptom-triggered use of benzodiazepines in patients monitored for alcohol withdrawal syndrome with the CIWA.
The Primary objective of this study is to determine if prophylactic VPA acid is associated with decreased lorazepam use in patients monitored for alcohol withdrawal syndrome with the CIWA.
Secondary objectives are:
To evaluate the difference between comparator arms with respect to:
- CIWA scores between patients with and without VPA prophylaxis
- Hospital and Intensive Care Unit (ICU) length of stay
- In-hospital mortality
- VPA acid associated side effects (e.g. thrombocytopenia, transaminitis, pancreatitis)
This will be single-center prospective, randomized study, enrolling trauma patients with a history of alcohol consumption admitted to a Level 1 trauma center. Patients included in this study will receive standard therapies for AWS practiced at study institution which include monitoring of withdrawal symptoms and the administration of BZDs (lorazepam) based on CIWA monitoring.
Following informed consent, patients will be randomized to receive CIWA protocol monitoring/BZD or CIWA protocol monitoring/BZD and VPA. Therefore, patients that meet the inclusion criteria will be separated into two study groups to compare outcomes:
- Treatment Group: Patients treated with CIWA protocol/BZD and VPA
- Control Group: Patients treated with CIWA protocol/BZD only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIWA Protocol/BZD and Valproate | Experimental | Drug: Valproate, Drug: Lorazepam1. Interventions to decrease symptoms of AWS will be made based on the CIWA tool. * CIWA Score 9-14: 1 mg IV push lorazepam * CIWA Score >15: 2 mg IV push lorazepam 2. Patients who have a known history of alcohol withdrawal seizures or who have received greater than 4 mg IV lorazepam per CIWA protocol will be placed on a scheduled lorazepam regimen, 1 mg every 6 hours. The primary managing service may increase the scheduled lorazepam regimen above 1mg every 6 hours if needed to control withdrawal symptoms. Scheduled lorazepam will be discontinued or de-escalated following a 24-hour period in which no additional lorazepam was received per CIWA protocol. 3. The treatment group will also receive scheduled valproate (VPA), 15 mg/kg divided over 4 doses, rounded up to the nearest increment of 50mg (i.e. a 70 kg person would be administered 300 mg IV VPA every 6 hours) for 96 hours. |
| CIWA Protocol Only | Active comparator | Drug: Lorazepam1. Interventions to decrease symptoms of AWS will be made based on the CIWA tool * CIWA Score 9-14: 1 mg IV push lorazepam * CIWA Score >15: 2 mg IV push lorazepam 2. Patients who have a known history of alcohol withdrawal seizures or who have received greater than 4 mg IV lorazepam per CIWA protocol will be placed on a scheduled lorazepam regimen, 1 mg every 6 hours. The primary managing service may increase the scheduled lorazepam regimen above 1mg every 6 hours if needed to control withdrawal symptoms. Scheduled lorazepam will be discontinued or de-escalated following a 24-hour period in which no additional lorazepam was received per CIWA protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Admission to Trauma Services
- Heavy drinkers based on social history
- Moderate or severe alcohol use disorder based on social history and DSM-5 criteria
Key exclusion criteria (12 listed)
- Intubated patients
- Glasgow Coma Score <8
- Grade IV liver laceration or greater
- Child-Pugh Class B or greater, history of cirrhosis, or cirrhosis identified by radiographic imaging upon admission
- Transaminase (AST/ALT) elevation of ≥ 2x normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValproateValproate is an anti-epileptic medication that can influence the chemical changes in the brain that result from alcohol withdrawal syndrome (AWS) via three mechanisms of action: (1) an increase in GABA activity, (2) inhibition of glutamate binding to NMDA, and (3) restoration of the balance between dopamine and acetylcholine activity. VPA may be effective in the prevention of AWS, and could serve as efficacious adjuvant to traditional benzodiazepine (BZD) therapy for AWS, both decreasing symptoms of AWS and decreasing the use of BZDs. | Drug | CIWA Protocol/BZD and Valproate |
| LorazepamLorazepam is a benzodiazepine used to treat symptoms of AWS. Standard of care at CAMC is monitoring by CIWA tool and administration of lorazepam according to CIWA score. | Drug | CIWA Protocol Only, CIWA Protocol/BZD and Valproate |
Primary outcome
Lorazepam use in patient monitored with CIWA
Time frame: Time between CIWA initiation and discontinuation for up to 3 weeks
Amount of lorazepam administration in response to CIWA score
5 secondary outcomes
CIWA score
Time frame: During patient hospital stay for up to 6 months
Hospital Length of Stay
Time frame: During patient hospital stay for up to 6 months
Intensive Care Unit Length of Stay
Time frame: During patient Intensive Care Unit stay for up to 6 months
In-hospital Mortality
Time frame: During patient hospital stay for up to 6 months
Valproate associated side effects
Time frame: During patient hospital stay for up to 6 months
Results and safety
The study was stopped early (reason given: PI left site without transferring study to another PI. Study expired and was not renewed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 20837230Eastes LE. Alcohol withdrawal syndrome in trauma patients: a review. J Emerg Nurs. 2010 Sep;36(5):507-9. doi: 10.1016/j.jen.2010.05.011. Epub 2010 Aug 5. No abstract available.
- Background: PubMed 8284718Craft PP, Foil MB, Cunningham PR, Patselas PC, Long-Snyder BM, Collier MS. Intravenous ethanol for alcohol detoxification in trauma patients. South Med J. 1994 Jan;87(1):47-54. doi: 10.1097/00007611-199401000-00011.
- Background: PubMed 28343640Makic MB. Alcohol Withdrawal Syndrome. J Perianesth Nurs. 2017 Apr;32(2):140-141. doi: 10.1016/j.jopan.2017.01.007. No abstract available.
- Background: PubMed 16203295Foy A, Kay J. The incidence of alcohol-related problems and the risk of alcohol withdrawal in a general hospital population. Drug Alcohol Rev. 1995;14(1):49-54. doi: 10.1080/09595239500185051.
- Background: PubMed 11391067Spies C, Tonnesen H, Andreasson S, Helander A, Conigrave K. Perioperative morbidity and mortality in chronic alcoholic patients. Alcohol Clin Exp Res. 2001 May;25(5 Suppl ISBRA):164S-170S. doi: 10.1097/00000374-200105051-00028.
- Background: PubMed 7864257Tsai G, Gastfriend DR, Coyle JT. The glutamatergic basis of human alcoholism. Am J Psychiatry. 1995 Mar;152(3):332-40. doi: 10.1176/ajp.152.3.332.
- Background: PubMed 9509257Tsai G, Coyle JT. The role of glutamatergic neurotransmission in the pathophysiology of alcoholism. Annu Rev Med. 1998;49:173-84. doi: 10.1146/annurev.med.49.1.173.
- Background: PubMed 17986499McKeon A, Frye MA, Delanty N. The alcohol withdrawal syndrome. J Neurol Neurosurg Psychiatry. 2008 Aug;79(8):854-62. doi: 10.1136/jnnp.2007.128322. Epub 2007 Nov 6.
- Background: PubMed 21678378Amato L, Minozzi S, Davoli M. Efficacy and safety of pharmacological interventions for the treatment of the Alcohol Withdrawal Syndrome. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD008537. doi: 10.1002/14651858.CD008537.pub2.
- Background: PubMed 12724485Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. doi: 10.1056/NEJMra020617. No abstract available.
- Background: PubMed 18929939Maldonado JR. Delirium in the acute care setting: characteristics, diagnosis and treatment. Crit Care Clin. 2008 Oct;24(4):657-722, vii. doi: 10.1016/j.ccc.2008.05.008.
- Background: PubMed 21068014Clegg A, Young JB. Which medications to avoid in people at risk of delirium: a systematic review. Age Ageing. 2011 Jan;40(1):23-9. doi: 10.1093/ageing/afq140. Epub 2010 Nov 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audis Bethea, PharmD, BCPS principal investigator
Charleston Area Medical Center Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valproate and Lorazepam in people with Alcohol Dependence and Alcohol Withdrawal Syndrome, run by CAMC Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left site without transferring study to another PI. Study expired and was not renewed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lorazepam use in patient monitored with CIWA (time frame: Time between CIWA initiation and discontinuation for up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235531, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.