The Effects of Sedatives on Tobacco Use Disorder Version 2 (SED-TUD2)

This early Phase I crossover trial (n=52) will investigate the effects of intravenous doses of ketamine, midazolam, dexmedetomidine, or a placebo (saline) on cigarette smoking behaviour, craving, and neural effects.

Conducted by Wake Forest University Health Sciences, non-treatment-seeking smokers will receive one of these infusions at least two weeks apart. Participants will undergo a 7-day ecological momentary assessment (EMA) of daily craving, withdrawal, and smoking behaviour before and after each infusion. They will then abstain from tobacco/nicotine for 24 hours post-infusion to induce withdrawal symptoms and return for further assessments.

The primary outcome measures include the difference in craving, withdrawal symptoms, cigarette demand, and the number of cigarettes smoked ad lib between drug and placebo conditions, assessed 24 hours post-infusion.

The study employs a randomized, double-blind, crossover design and is estimated to be completed by December 2024.

Trial Details

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.

NCT Number NCT05505630

Data attribution

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