Trial Outcomes & Findings for Treating Alcohol Withdrawal With Oral Baclofen (NCT NCT00597701)

Last Updated: 2011-07-27

Results Overview

In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.

Results posted on

2011-07-27

Participant Flow

Seventy-nine subjects met study inclusion criteria, and provided informed consent for participation in the study.

Of 79 enrolled subjects, 44 developed signs of Alcohol Withdrawal Syndrome (AWS) sufficient to meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for AWS. These 44 were randomized to receive baclofen or placebo, in addition to benzodiazepine therapy. Of the 44 subjects randomized, 31 completed 72 hours of observation.

Participant milestones

Participant milestones
Measure	Baclofen Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.	Placebo Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
Overall Study STARTED	25	21
Overall Study COMPLETED	18	13
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Baclofen Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.	Placebo Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
Overall Study Withdrawal by Subject	5	5
Overall Study Death	0	1
Overall Study Physician Decision	2	0
Overall Study Did not start intervention (pharmacy er)	0	2

Baseline Characteristics

Treating Alcohol Withdrawal With Oral Baclofen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baclofen n=25 Participants Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.	Placebo n=19 Participants Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	47.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	46.1 years STANDARD_DEVIATION 11.9 • n=7 Participants	46.9 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	19 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.

Outcome measures

Outcome measures
Measure	Baclofen n=25 Participants Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.	Placebo n=21 Participants Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups	14.1 mg of benzodiazepine per 8 hours Standard Deviation 8.9	124.4 mg of benzodiazepine per 8 hours Standard Deviation 290.3

Adverse Events

Baclofen

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baclofen n=25 participants at risk Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.	Placebo n=19 participants at risk Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
General disorders Rapid progression of complications of alcoholism	8.0% 2/25 • Number of events 2	5.3% 1/19 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Charles E Gessert, MD, MPH

Essentia Health

Phone: 218-786-8176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place