Phase 2 N=10 Randomized Single-blind Basic Science

The Effects of Sedatives on Tobacco Use Disorder

Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03813121 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Side Effects — 1.3; 1.4 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: midazolam intravenous infusion (Drug); placebo intravenous infusion (Drug); ketamine intravenous infusion (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Side Effects	1.3; 1.4	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03813121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.