The Effects of Sedatives on Tobacco Use Disorder

Phase 1

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: midazolam intravenous infusion; Drug: ketamine intravenous infusion; Drug: placebo intravenous infusion

• Registration Number: NCT03813121
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-23
• Study Start: 2019-06-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Results First Submitted: 2022-04-11
• Results First Submitted QC: 2022-06-01
• Results First Posted: 2022-06-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam intravenous infusion	midazolam intravenous infusion	single midazolam infusion (0.02 mg/kg over 20 minutes)
ketamine intravenous infusion	ketamine intravenous infusion	single ketamine infusion (0.5 mg/kg over 20 minutes)
placebo intravenous infusion	placebo intravenous infusion	single placebo infusion (saline over 20 minutes)

Primary Outcome Measures

Name	Time	Method
Side Effects	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.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States