drugset / Trial / NCT04229095

Medication Development in Alcoholism: Suvorexant Versus Placebo

NCT04229095

RandomizedParallel-groupQuadruple-blindOther

Summary

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.

Timeline

Start
2021-11-17
Primary completion
2022-11-08
Completion
2022-11-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Suvorexant Small molecule 20 mg

Indications