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CompletedEarly Phase 1

The Effects of Sedatives on Tobacco Use Disorder Version 2

NCT05505630 · SED-TUD2 · Wake Forest University Health Sciences

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

Double-blind, placebo-controlled, randomized mechanistic clinical trial to test an intravenous dose of either ketamine, midazolam, dexmedetomidine, or a placebo (saline) on cigarette smoking behavior, craving, and neural effects.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Difference in craving between drug and placebo

    Measured over 24-hours post infusion

  • Difference in tobacco withdrawal symptoms

    Measured over 24-hours post infusion

  • Difference in cigarette demand

    Measured over 24-hours post infusion

  • Number of cigarettes smoked ad lib

    Measured over 24-hours post infusion

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 55 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Smokes cigarettes daily for at least 2 years * Afternoon expired breath carbon monoxide at least 5 ppm or morning urinary cotinine at least 100 ng/ml * Negative urine drug screen for psychoactive drugs and negative breath alcohol Exclusion Criteria: * Have an unstable medical condition or stable medical condition that would interact with study drug or participation, including chronic pulmonary disease, coronary artery disease, current brain tumor, current increased intracranial pressure or impaired consciousness * History of serious head trauma or neurological disorder (e.g., seizure disorder) * Have any of the following: hypertension (i.e., systolic \>140 mm Hg and/or diastolic \>90 mm Hg on three separate measures; systolic \>170 or diastolic \> 110 on any occasion), pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). * Use of drugs that would interact with study drug or increase risk of adverse events * Among women, pregnancy or lactation

Where

1 study site

FacilityCityRegionCountry
Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05505630 on ClinicalTrials.gov →

Last updated in the registry 2026-04-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits