drugset / Trial / NCT04229095
Medication Development in Alcoholism: Suvorexant Versus Placebo
Phase 2
Completed
26 enrolled
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Suvorexant | Small molecule | 20 mg | — |