Phenobarbital for Acute Alcohol Withdrawal

• Sponsor: Jonathan Rosenson (Other)
• Overall Status: Completed
• CT.gov ID: NCT01184417
• Collaborator: Alameda County Medical Center (Other)
• Enrollment: 102
• Location: 1
• Arms: 2
• Duration (Months): 13.9
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Withdrawal	Drug: 10 mg/kg IV phenobarbital in 100 ml saline; Drug: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phenobarbital group 10 mg/kg IV phenobarbital in 100 ml saline	Drug: 10 mg/kg IV phenobarbital in 100 ml saline; 10 mg/kg IV phenobarbital in 100 ml saline
Placebo Comparator: Placebo group 100 ml saline	Drug: placebo; 100 m l saline

Outcome Measures

Primary Outcome Measures

1. Number of Patients Requiring Continuous Lorazepam Infusion [1 year]

   All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).

2. Percentage of Patients Requiring ICU Admission [1 year]

   admission to intensive care unit

3. Total Lorazepam Required Per Patient Per Admission [1 year]

   How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.

Secondary Outcome Measures

1. Length of Stay [1 year]

   hospital LOS, per patient, in hours from admission to discharge

2. Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability [1 year]

   The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.

3. Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability [1 year]

   Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.

4. Number of Study Patients With Seizure as a Measure of Safety and Tolerability [1 year]

   Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).

5. Number of Study Patients With Mortality as a Measure of Safety and Tolerability [1 year]

   mortality in study patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

• allergy to phenobarbital, lorazepam, age<18 or >65

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alameda County Medical Center	Oakland	California	United States	94608

Sponsors and Collaborators

• Jonathan Rosenson
• Alameda County Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan Rosenson, Jonathan Rosenson MD, Alameda County Medical Center
• ClinicalTrials.gov Identifier: NCT01184417
• Other Study ID Numbers: AlamedaCountyMC
• First Posted: Aug 19, 2010
• Last Update Posted: Mar 9, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Phenobarbital

Study Results

Participant Flow

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Period Title: Overall Study
STARTED	51	51
COMPLETED	51	51
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Phenobarbital Group	Placebo Group	Total
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline	Total of all reporting groups
Overall Participants	51	51	102
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	51 100%	51 100%	102 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (12)	48 (17)	47 (14)
Sex: Female, Male (Count of Participants)
Female	46 90.2%	45 88.2%	91 89.2%
Male	5 9.8%	6 11.8%	11 10.8%
Region of Enrollment (participants) [Number]
United States	51 100%	51 100%	102 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Requiring Continuous Lorazepam Infusion
Description	All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Number [participants]	2 3.9%	16 31.4%

2. Primary Outcome

Title	Percentage of Patients Requiring ICU Admission
Description	admission to intensive care unit
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Number [percentage of participants]	8 15.7%	25 49%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phenobarbital Group, Placebo Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	17
	Confidence Interval	(2-Sided) 95%; 4 to 32
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Total Lorazepam Required Per Patient Per Admission
Description	How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Mean (Standard Deviation) [milligrams]	26 (45)	49 (37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phenobarbital Group, Placebo Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23
	Confidence Interval	(2-Sided) 95%; 4 to 49
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Length of Stay
Description	hospital LOS, per patient, in hours from admission to discharge
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Median (Inter-Quartile Range) [hours]	76	118

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phenobarbital Group, Placebo Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	42
	Confidence Interval	(2-Sided) 95%; -4 to 82
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability
Description	The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Number [participants]	0 0%	0 0%

6. Secondary Outcome

Title	Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability
Description	Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Number [percentage of participants]	28 54.9%	22 43.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Phenobarbital Group, Placebo Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6
	Confidence Interval	(2-Sided) 95%; -11 to 23
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Study Patients With Seizure as a Measure of Safety and Tolerability
Description	Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Number [participants]	1 2%	2 3.9%

8. Secondary Outcome

Title	Number of Study Patients With Mortality as a Measure of Safety and Tolerability
Description	mortality in study patients
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phenobarbital Group	Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline	100 ml saline
Measure Participants	51	51
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Phenobarbital Group		Placebo Group
Arm/Group Description	10 mg/kg IV phenobarbital in 100 ml saline		100 ml saline
All Cause Mortality
	Phenobarbital Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Phenobarbital Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Phenobarbital Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.