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

Tobacco Smoking Clinical Trial

Official title:
The Effects of Sedatives on Tobacco Use Disorder Version 2

Clinical Trial 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.

Clinical Trial Description

This double-blind, placebo-controlled, randomized mechanistic clinical trial will test non-treatment seeking smokers with an intravenous infusion of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or placebo, at least 2 weeks apart. Participants will complete 7-day ecological momentary assessment (EMA) of daily craving, withdrawal, and smoking behavior before and after each infusion. They will be asked to abstain from tobacco/nicotine for twenty-four hours post-infusion to induce withdrawal symptoms and return to the lab the following day to complete measures of craving, withdrawal, an MRI scan, and smoking latency. After this study visit, participants will be allowed to smoke as usual for the rest of the EMA diary period. Physical and subjective effects and adverse effects will be closely monitored throughout. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05505630
Study type Interventional
Source Wake Forest University Health Sciences
Contact Merideth Addicott
Phone 336-716-7792
Email maddicot@wakeforest.edu
Status Recruiting
Phase Early Phase 1
Start date January 31, 2023
Completion date December 2024
View Details
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