Ignite Creation Date:
2024-05-05 @ 10:55 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01212185
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2010-09-28
Brief Title:
Oxytocin Treatment of Alcohol Withdrawal
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Oxytocin Treatment of Alcohol Withdrawal
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose Test whether intranasal administration of the neuropeptide oxytocin is effective in decreasing alcohol withdrawal symptoms the number of bouts of withdrawal requiring standard medication treatment lorazepam and the amount of lorazepam required to control withdrawal bouts in individuals undergoing medical detoxification Also determine rates of subject recruitment and retention in the inpatient setting
Participants 80 alcohol dependent patients 18-65 years of age admitted for medical detoxification
Procedures methods Subjects will be inpatients undergoing medical detoxification from alcohol Oxytocin or placebo will be administered in a nasal spray twice daily in a randomized double blind manner for three days Withdrawal symptoms will be measured routinely at q4 hours and prn for length of hospital stay Lorazepam will be given whenever withdrawal symptoms increase above specific parameters
Participants 80 alcohol dependent patients 18-65 years of age admitted for medical detoxification
Procedures methods Subjects will be inpatients undergoing medical detoxification from alcohol Oxytocin or placebo will be administered in a nasal spray twice daily in a randomized double blind manner for three days Withdrawal symptoms will be measured routinely at q4 hours and prn for length of hospital stay Lorazepam will be given whenever withdrawal symptoms increase above specific parameters
Detailed Description:
Study Design This will be a double-blind placebo controlled comparison of the efficacy of twice daily intranasal administration of oxytocin and placebo saline in reducing alcohol withdrawal symptoms the number of bouts of withdrawal during which symptoms are of sufficient magnitude requiring prn lorazepam treatment see definitions below and the amount of lorazepam required to resolve withdrawal bouts Treatment group assignment will be random within each sex Subjects will be patients admitted to University of North Carolina UNC Hospitals or the Dix Clinical Research Unit CRU for medical detoxification Each treatment group will be composed of up to 40 subjects Dr Hamer the study statistician will construct a randomization plan to randomize 80 subjects to 2 groups of 40 subjects each with a blocksize of 4 This will be a permuted blocksize as this is a blind study
Procedures Most patients who are admitted to the UNC Neuroscience Hospital Crisis Stabilization Unit UNC Hospitals Family Practice or Hospitalist Services or the Dix CRU for medical detoxification from alcohol will come in through the UNC Hospitals Emergency Department or Dorothea Dix Screening and Admissions during the late evening or early morning Physical examination medical and psychiatric history and lab tests including complete blood count CBC magnesium sodium potassium blood urea nitrogen BUN creatinine glucose albumin liver functions tests ALT AST LDH GGT throid-stimulating hormone TSH B12 folate urinalysis urine toxicology screen and pregnancy test are routinely obtained by the emergency department ED Dorothea Dix Screening and Admissions andor inpatient unit during the admission process Possibly in the UNC Hospitals ED Dorothea Dix Screening and Admissions and definitely after admission to these units patients will have their vital signs VSs measured and their withdrawal symptoms quantified using the revised Clinical Institute Withdrawal Assessment for Alcohol scale CIWA-Ar scale Sullivan et al 1989 on the schedule in the standard alcohol detoxification order set in the UNC Hospital electronic medical records system CPOE system The CRU at Dorothea Dix will use a hard copy version of the CIWA used in the CPOE at UNC Hospitals
After consent is obtained subjects will be randomly assigned to a treatment group oxytocin or placebo Prior to receiving their first intranasal treatment an ECG will be obtained and blood drawn to obtain serum for assay of cytokine and allopregnanolone concentrations Subjects also will rate their symptoms using the Alcohol Withdrawal Symptom Checklist AWSC Pittman et al 2007 prior to receiving their first test dose These procedures will be doneoverseen by research nurses or physicians Subjects will usually receive their first intranasal test dose between 1000 and 1200 hours and will consist of 6 insufflations of Syntocinon Spray approximately 24 IU or placebo with each insufflation given 30 seconds apart and alternating between nostrils Test doses will be taken again at 1700 hr later that day Admission Day 1 and at 0900 and 1700 hr on Admission Days 2 and 3 Oxytocin test treatments will be administered from 5 ml intranasal spray vials designed to deliver 01 ml metered volume per insufflation The placebo treatments will be administered from 60 ml intranasal spray vials each containing 30ml of solution also designed to deliver 01ml metered volume per insufflation Vials containing oxytocin and placebo spray will be blind labeled by the UNC Investigational Drug Service or the Dorothea Dix Hospital pharmacy Research nurses or physicians will oversee subject self-administration of all intranasal test doses After enrollment on admission day 1 and in the morning on admission days 2 and 3 subjects will be given multiple copies of the AWSC questionnaire and requested to complete one each time the unit nurses do CIWA ratings These questionnaires will be retrieved by research staff the following morning Shortly after the morning test dose on admission days 2 and 3 subjects will complete the Alcohol Craving Visual Analog Scales ACVAS the Penn Alcohol Craving Scale and the Profile of Mood States McNair et al 1971 On these same admission days research nurses will also draw and subsequently process blood serum samples to assay cytokine and allopregnanolone concentrations shortly after the morning test dose Additional blood will be drawn after the morning test dose on admission day 2 to obtain serum for tests to be run in McLendon Laboratories magnesium chloride calcium sodium potassium BUN creatinine and liver function tests Another electrocardiogram ECG will also be obtained shortly after the morning test treatment on admission day 2 Research staff will retrieve on a daily basis CIWA ratings and vital sign measurements obtained on each subject from their electronic medical record
In all subjects PRN lorazepam doses will be administered by mouth PO or intravenously IV if subjects cannot take medication PO whenever CIWA ratings are 14 per the protocol in the standard alcohol detoxification order set in the UNC Hospital CPOE system Lorazepam doses 1 - 4 mg and frequency q 2 -6 h will be adjusted based on the severity of withdrawal symptoms This same order set will be employed at the Dorothea Dix CRU
Procedures Most patients who are admitted to the UNC Neuroscience Hospital Crisis Stabilization Unit UNC Hospitals Family Practice or Hospitalist Services or the Dix CRU for medical detoxification from alcohol will come in through the UNC Hospitals Emergency Department or Dorothea Dix Screening and Admissions during the late evening or early morning Physical examination medical and psychiatric history and lab tests including complete blood count CBC magnesium sodium potassium blood urea nitrogen BUN creatinine glucose albumin liver functions tests ALT AST LDH GGT throid-stimulating hormone TSH B12 folate urinalysis urine toxicology screen and pregnancy test are routinely obtained by the emergency department ED Dorothea Dix Screening and Admissions andor inpatient unit during the admission process Possibly in the UNC Hospitals ED Dorothea Dix Screening and Admissions and definitely after admission to these units patients will have their vital signs VSs measured and their withdrawal symptoms quantified using the revised Clinical Institute Withdrawal Assessment for Alcohol scale CIWA-Ar scale Sullivan et al 1989 on the schedule in the standard alcohol detoxification order set in the UNC Hospital electronic medical records system CPOE system The CRU at Dorothea Dix will use a hard copy version of the CIWA used in the CPOE at UNC Hospitals
After consent is obtained subjects will be randomly assigned to a treatment group oxytocin or placebo Prior to receiving their first intranasal treatment an ECG will be obtained and blood drawn to obtain serum for assay of cytokine and allopregnanolone concentrations Subjects also will rate their symptoms using the Alcohol Withdrawal Symptom Checklist AWSC Pittman et al 2007 prior to receiving their first test dose These procedures will be doneoverseen by research nurses or physicians Subjects will usually receive their first intranasal test dose between 1000 and 1200 hours and will consist of 6 insufflations of Syntocinon Spray approximately 24 IU or placebo with each insufflation given 30 seconds apart and alternating between nostrils Test doses will be taken again at 1700 hr later that day Admission Day 1 and at 0900 and 1700 hr on Admission Days 2 and 3 Oxytocin test treatments will be administered from 5 ml intranasal spray vials designed to deliver 01 ml metered volume per insufflation The placebo treatments will be administered from 60 ml intranasal spray vials each containing 30ml of solution also designed to deliver 01ml metered volume per insufflation Vials containing oxytocin and placebo spray will be blind labeled by the UNC Investigational Drug Service or the Dorothea Dix Hospital pharmacy Research nurses or physicians will oversee subject self-administration of all intranasal test doses After enrollment on admission day 1 and in the morning on admission days 2 and 3 subjects will be given multiple copies of the AWSC questionnaire and requested to complete one each time the unit nurses do CIWA ratings These questionnaires will be retrieved by research staff the following morning Shortly after the morning test dose on admission days 2 and 3 subjects will complete the Alcohol Craving Visual Analog Scales ACVAS the Penn Alcohol Craving Scale and the Profile of Mood States McNair et al 1971 On these same admission days research nurses will also draw and subsequently process blood serum samples to assay cytokine and allopregnanolone concentrations shortly after the morning test dose Additional blood will be drawn after the morning test dose on admission day 2 to obtain serum for tests to be run in McLendon Laboratories magnesium chloride calcium sodium potassium BUN creatinine and liver function tests Another electrocardiogram ECG will also be obtained shortly after the morning test treatment on admission day 2 Research staff will retrieve on a daily basis CIWA ratings and vital sign measurements obtained on each subject from their electronic medical record
In all subjects PRN lorazepam doses will be administered by mouth PO or intravenously IV if subjects cannot take medication PO whenever CIWA ratings are 14 per the protocol in the standard alcohol detoxification order set in the UNC Hospital CPOE system Lorazepam doses 1 - 4 mg and frequency q 2 -6 h will be adjusted based on the severity of withdrawal symptoms This same order set will be employed at the Dorothea Dix CRU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None