The Effects of Sedatives on Tobacco Use Disorder

Purpose

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.

Condition

  • Tobacco Use Disorder

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Single (Participant)
Masking Description
single-blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
midazolam intravenous infusion 		single midazolam infusion (0.02 mg/kg over 20 minutes)
  • Drug: midazolam intravenous infusion
    Participants will receive a single drug infusion
Placebo Comparator
placebo intravenous infusion 		single placebo infusion (saline over 20 minutes)
  • Drug: placebo intravenous infusion
    Participants will receive a single placebo infusion
Experimental
ketamine intravenous infusion 		single ketamine infusion (0.5 mg/kg over 20 minutes)
  • Drug: ketamine intravenous infusion
    Participants will receive a single drug infusion

Recruiting Locations

More Details

NCT ID
NCT03813121
Status
Completed
Sponsor
Wake Forest University Health Sciences