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NCT03813121 Clinical Trial

The Effects of Sedatives on Tobacco Use Disorder

Tobacco Use Disorder Clinical Trial

— SED-TUD  

Official title:
The Effects of Sedatives on Tobacco Use Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03813121
Other study ID # IRB000229077
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 1, 2019
Est. completion date August 31, 2021

Study information
Verified date August 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - smoke at least 5 cigarettes per day - smoked at least 2 years - negative urine drug screen for psychoactive drugs and negative breath alcohol concentration - live in Little Rock AR or surrounding area Exclusion Criteria: - unstable or stable medical condition that would interact with study medication or participation - serious head trauma or neurological disorder - hypertension, abnormal ECG or metabolic blood results - meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder - use of psychoactive drugs or medications - BMI > 40 - among women, pregnancy or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• midazolam intravenous infusion
Participants will receive a single drug infusion
• placebo intravenous infusion
Participants will receive a single placebo infusion
• ketamine intravenous infusion
Participants will receive a single drug infusion

Locations
Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

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 Side Effects drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported. about 1 week post infusion
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