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

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

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Merideth Addicott, PhD
501-526-8436
maddicott@uams.edu

More Details

NCT ID
NCT03813121
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Merideth Addicott, PhD
5015268436
MAddicott@uams.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.