The Effects of Sedatives on Tobacco Use Disorder

Wake Forest University Health Sciences10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Tobacco Use Disorder

Interventions

midazolam intravenous infusionDRUG

Participants will receive a single drug infusion

placebo intravenous infusionDRUG

Participants will receive a single placebo infusion

ketamine intravenous infusionDRUG

Participants will receive a single drug infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: about 1 week post infusion

Data from ClinicalTrials.gov

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