NCT04234997

Suvorexant to Reduce Symptoms of Nicotine Use

Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the impact of suvorexant on established measures of smoking relapse risk (craving,withdrawal, stress reactivity, latency to self-administration) and to validate the somnolent effect of suvorexant on sleep metrics in a sample of individuals with tobacco use disorder

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Suvorexant 20 mg	Participants will be advised to take the medication at 10PM for 7 days.Participants will be instructed to stop smoking by 10 pm the day before, in order to ensure they meet the breath CO criterion (CO ≤ 4 ppm) indicating overnight abstinence.
DRUG	Suvorexant 0mg	Participants will be advised to take the medication at 10PM for 7 days.Participants will be instructed to stop smoking by 10 pm the day before, in order to ensure they meet the breath CO criterion (CO ≤ 4 ppm) indicating overnight abstinence.

Timeline

• Start date: 2021-08-23
• Primary completion: 2024-08-22
• Completion: 2024-08-22
• First posted: 2020-01-21
• Last updated: 2025-10-01
• Results posted: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study