CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Suvorexant 20 mg +1 moredrug
Likely dose
Suvorexant 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04234997
NCT04234997Phase 2Completed
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Suvorexant to Reduce Symptoms of Nicotine Use: A Double-blind, Placebo-controlled Study

The University of Texas Health Science Center, Houston·interventional·Posted Jan 21, 2020·Updated Oct 1, 2025

In Brief

A Phase 2 clinical trial evaluating Suvorexant 20 mg and Suvorexant 0mg for Smoking Cessation. Completed, enrolled 14 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 21, 2020
Enrollment StartAug 23, 2021
Primary CompletionAug 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.4 years ago

Interventions

Suvorexant 20 mgdrug

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.

Suvorexant 0mgdrug

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.