NCT05505630

The Effects of Sedatives on Tobacco Use Disorder Version 2

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tobacco Smoking

Interventions

Type	Name	Description
DRUG	Ketamine	A single dose of IV ketamine will be administered.
DRUG	Midazolam	A single dose of IV midazolam will be administered
DRUG	Dexmedetomidine	A single dose of IV dexmedetomidine will be administered
DRUG	Saline	A single dose of IV saline will be administered

Timeline

• Start date: 2023-01-31
• Primary completion: 2025-12-10
• Completion: 2025-12-10
• First posted: 2022-08-18
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study