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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental midazolam intravenous infusion |
single midazolam infusion (0.02 mg/kg over 20 minutes) |
|
|
Placebo Comparator placebo intravenous infusion |
single placebo infusion (saline over 20 minutes) |
|
|
Experimental ketamine intravenous infusion |
single ketamine infusion (0.5 mg/kg over 20 minutes) |
|
Recruiting Locations
More Details
- NCT ID
- NCT03813121
- Status
- Completed
- Sponsor
- Wake Forest University Health Sciences