The Effects of Sedatives on Tobacco Use Disorder Version 2

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Ketamine; Midazolam

Criteria

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), liver function test (alanine transaminase) >3 times normal, Blood Urea Nitrogen and Creatinine outside normal range; ECG (electrocardiogram) abnormalities including but not limited to: bradycardia (<55 beats per minute); prolonged corrected QT Framingham formula interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).

• Meet criteria for lifetime psychosis, schizophrenia, or bipolar disorder or current major depressive disorder

• Meet DSM-5 criteria for moderate to severe substance use disorder within the past 6 months other than tobacco/nicotine

• Use of psychoactive medications or other drugs that would interact with study drug

• History of regular use of ketamine or benzodiazepines for nonmedical purposes

• Among women, pregnancy or lactation

• Body Mass Index > 40 and/or weight > 350 pounds

• Vision cannot be corrected to 20/40