The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of \> 5 versus \<5. Subjects were also stratified by sex.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
26
Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit
Single-dose administration of placebo given on an inpatient clinical research unit
Scripps Research
La Jolla, California, United States
Visual Analogue Scale (VAS) of Craving Severity: 2 Arms
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
Time frame: 1 hour during cue reactivity session
Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
Time frame: 1 hour during cue reactivity session
Number of Standard Drinks Per Day: 2 Arms
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcohol drinks consumed per day with a minimum value of 0 and an undetermined maximum value
Time frame: Up to one week following single dose administration
Number of Standard Drinks Per Day: Combined Arms Conditional Model
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.
Time frame: Up to one week following single dose administration
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