Trial Outcomes & Findings for Acamprosate to Reduce Symptoms of Alcohol Withdrawal (NCT NCT00106106)

Last Updated: 2012-01-12

Results Overview

The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Day 4

Results posted on

2012-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo For subjects randomized to placebo control, placebo doses were given every 8 hours.	Acamprosate For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
Overall Study STARTED	26	23
Overall Study Completed Both MRS Scans	18	15
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acamprosate to Reduce Symptoms of Alcohol Withdrawal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants For subjects randomized to placebo control, placebo doses were given every 8 hours.	Acamprosate n=23 Participants For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.	Total n=49 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	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	35.1 years STANDARD_DEVIATION 6.1 • n=5 Participants	35.0 years STANDARD_DEVIATION 5.8 • n=7 Participants	35.1 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	23 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 4

Population: The analysis of participants was per protocol, i.e., all subjects who completed two MRS scans(Day 4 and Day 25) and for whom there were two measures of the glutamate/creatine ratio

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants For subjects randomized to placebo control, placebo doses were given every 8 hours.	Acamprosate n=15 Participants For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4	1.256772 Ratio of glutamate to creatine Standard Error 0.038924	1.294178 Ratio of glutamate to creatine Standard Error 0.043249

PRIMARY outcome

Timeframe: Day 25

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants For subjects randomized to placebo control, placebo doses were given every 8 hours.	Acamprosate n=15 Participants For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25	1.350375 Ratio of glutamate to creatine Standard Error 0.044497	1.166667 Ratio of glutamate to creatine Standard Error 0.049441

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Acamprosate

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=22 participants at risk；n=26 participants at risk For subjects randomized to placebo control, placebo doses were given every 8 hours.	Acamprosate n=19 participants at risk；n=23 participants at risk For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
General disorders Vaso-vagal faint	0.00% 0/26	4.3% 1/23 • Number of events 1

Other adverse events

Other adverse events
Measure	Placebo n=22 participants at risk；n=26 participants at risk For subjects randomized to placebo control, placebo doses were given every 8 hours.	Acamprosate n=19 participants at risk；n=23 participants at risk For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
Nervous system disorders Abnormal Dreaming	50.0% 11/22	57.9% 11/19
Nervous system disorders Anxiety	40.9% 9/22	63.2% 12/19
Nervous system disorders Decreased interest in sex	27.3% 6/22	31.6% 6/19
Gastrointestinal disorders Diarrhea	13.6% 3/22	31.6% 6/19
Nervous system disorders Dizziness	22.7% 5/22	31.6% 6/19
Nervous system disorders Feeling Down	40.9% 9/22	57.9% 11/19
General disorders Headaches	31.8% 7/22	63.2% 12/19
Nervous system disorders Impaired concentration	31.8% 7/22	36.8% 7/19
Gastrointestinal disorders Lack of appetite	13.6% 3/22	36.8% 7/19
General disorders Lack of energy	31.8% 7/22	52.6% 10/19
Nervous system disorders Mood swings	40.9% 9/22	68.4% 13/19
Musculoskeletal and connective tissue disorders Muscle spasms	22.7% 5/22	15.8% 3/19
Gastrointestinal disorders Nausea	9.1% 2/22	15.8% 3/19
Nervous system disorders Nervousness	31.8% 7/22	52.6% 10/19
Nervous system disorders Sensation of prickling or tingling on the skin	27.3% 6/22	10.5% 2/19
Nervous system disorders Shakiness	13.6% 3/22	36.8% 7/19
Nervous system disorders Sleepiness	68.2% 15/22	68.4% 13/19
Nervous system disorders Sleeplessness	45.5% 10/22	63.2% 12/19
General disorders Stomach aches	9.1% 2/22	42.1% 8/19
Gastrointestinal disorders Vomiting	4.5% 1/22	10.5% 2/19

Additional Information

Markus A. Heilig, M.D., Ph.D.

NIH/National Institute on Alcohol Abuse and Alcoholism

Phone: 301-435-9386

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place