Trial Outcomes & Findings for Preventing Alcohol Withdrawal With Oral Baclofen (NCT NCT01937364)

NCT ID: NCT01937364

Last Updated: 2017-05-05

Results Overview

Moderate or severe AWS was defined as a CIWA-AR score of at least 11.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2017-05-05

Participant Flow

Participant milestones

Measure	Placebo Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Overall Study STARTED	9	8
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Placebo Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Overall Study Adverse Event	2	1

Baseline Characteristics

Preventing Alcohol Withdrawal With Oral Baclofen

Baseline characteristics by cohort

Measure	Placebo n=9 Participants Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours	Baclofen n=8 Participants Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours	Total n=17 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 11.37 • n=5 Participants	48.9 years STANDARD_DEVIATION 11.97 • n=7 Participants	51.5 years STANDARD_DEVIATION 11.58 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants
Baseline Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)	4.4 units on a scale STANDARD_DEVIATION 2.01 • n=5 Participants	3.9 units on a scale STANDARD_DEVIATION 2.42 • n=7 Participants	4.2 units on a scale STANDARD_DEVIATION 2.16 • n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Subjects who either had AWS prior to the collection of the 72-hour CIWA-Ar score or had a CIWA-Ar score either recorded as the 72-hour CIWA-Ar score or occurring within the one-hour window for the 72-hour CIWA-Ar score are evaluable for this endpoint.

Moderate or severe AWS was defined as a CIWA-AR score of at least 11.

Outcome measures

Measure	Placebo n=5 Participants Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen n=7 Participants Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Moderate or Severe Alcohol Withdrawal Syndrome	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 72 hours

Population: All CIWA-Ar scores collected at and after the baseline measurement.

Range: 0 to 67; larger values indicate greater severity

Outcome measures

Measure	Placebo n=9 Participants Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen n=8 Participants Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment 24 hours	3.1325 units on a scale Standard Error 0.5283	2.4418 units on a scale Standard Error 0.5572
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment 48 hours	1.7913 units on a scale Standard Error 0.4666	1.9878 units on a scale Standard Error 0.4430
Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment 72 hours	0.4501 units on a scale Standard Error 0.5646	1.5339 units on a scale Standard Error 0.4179

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Placebo n=9 Participants Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.	Baclofen n=8 Participants Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Peak and Total Benzodiazepine Dose Required Peak Ativan 1mg PO equivalent dose	1.0 Doses Interval 0.0 to 2.0	0.5 Doses Interval 0.0 to 1.0
Peak and Total Benzodiazepine Dose Required Total Ativan 1mg PO equivalent dose	1.0 Doses Interval 0.0 to 3.0	0.5 Doses Interval 0.0 to 2.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Baclofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey E. Lyon, M.D.

Essentia Health

Phone: 218-786-2802

Email: jeffrey.lyon@essentiahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place