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Could sedatives help smokers quit? early study tests the idea

NCT ID NCT05505630

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small, early-phase study tested whether a single dose of sedatives like ketamine, midazolam, or dexmedetomidine could reduce cigarette cravings and smoking in 20 daily smokers. Participants received one of these drugs or a placebo (saline) and reported their cravings, withdrawal symptoms, and how many cigarettes they smoked. The goal was to understand how these drugs affect smoking behavior, not to find a treatment yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ketamine, Midazolam, Dexmedetomidine, Saline
What this could lead to
If successful, this could point toward new ways to help people quit smoking by targeting brain pathways involved in craving.
What could go wrong
This is a very small, early-phase study with only 20 participants. Results may not apply to all smokers, and the drugs have side effects like sedation and dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

20 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Tobacco Smoking

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tobacco smoking

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.