The Effects of Sedatives on Tobacco Use Disorder

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.

Completed

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam intravenous infusion

Drug

Participants will receive a single drug infusion

placebo intravenous infusion

Drug

Participants will receive a single placebo infusion

Ketamine Intravenous Infusion

Drug

Participants will receive a single drug infusion

Primary outcomes

Side Effects

Time frame: about 1 week post infusion

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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: SED-TUD

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jan 23, 2019
Registry last updated: Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed