The Effects of Sedatives on Tobacco Use Disorder (SED-TUD)

Wake Forest University (WFU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tobacco Use Disorder

Treatments: Drug: placebo intravenous infusion; Drug: ketamine intravenous infusion; Drug: midazolam intravenous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03813121

IRB000229077

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 3 patient groups, including a placebo group

midazolam intravenous infusion

Experimental group

Description:

single midazolam infusion (0.02 mg/kg over 20 minutes)

Treatment:

Drug: midazolam intravenous infusion

placebo intravenous infusion

Placebo Comparator group

Description:

single placebo infusion (saline over 20 minutes)

Treatment:

Drug: placebo intravenous infusion

ketamine intravenous infusion

Experimental group

Description:

single ketamine infusion (0.5 mg/kg over 20 minutes)

Treatment:

Drug: ketamine intravenous infusion