The Effects of Sedatives on Tobacco Use Disorder Version 2

Tobacco Smoking Clinical Trial

— SED-TUD2  

Official title:

The Effects of Sedatives on Tobacco Use Disorder Version 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505630
• Other study ID #: IRB00081012
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 31, 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: Merideth Addicott
• Phone: 336-716-7792
• Email: maddicot[@]wakeforest.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Drug:
• Ketamine
A single dose of IV ketamine will be administered.
• Midazolam
A single dose of IV midazolam will be administered
• Dexmedetomidine
A single dose of IV dexmedetomidine will be administered
• Saline
A single dose of IV saline will be administered

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in craving between drug and placebo	difference in self-reported craving for cigarettes after infusions	24-hours post infusion
Primary	Difference in tobacco withdrawal symptoms	difference in self-reported withdrawal symptoms after infusions	24-hours post infusion
Primary	Difference in cigarette demand	difference in self-reported cigarette demand after infusions	24-hours post infusion
Primary	Number of cigarettes smoked ad lib		24-hours post infusion