Tobacco Use Disorder
Conditions
Brief 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.
Interventions
DRUGmidazolam intravenous infusion
Participants will receive a single drug infusion
Participants will receive a single placebo infusion
Participants will receive a single drug infusion
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
single-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | about 1 week post infusion | drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported. |
Countries
United States
Participant flow
Pre-assignment details
Participants must be screened for eligibility before being assigned to a group. Participants deemed ineligible were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Intravenous Infusion single placebo infusion (saline over 20 minutes)
placebo intravenous infusion: Participants will receive a single placebo infusion | 4 |
| Ketamine Intravenous Infusion single ketamine infusion (0.5 mg/kg over 20 minutes)
ketamine intravenous infusion: Participants will receive a single drug infusion | 6 |
| Total | 10 |
Baseline characteristics
| Characteristic | Placebo Intravenous Infusion | Ketamine Intravenous Infusion | Total |
|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 11.2 | 35.5 years STANDARD_DEVIATION 15.4 | 36.3 years STANDARD_DEVIATION 13.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 4 participants | 6 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 |
| other Total, other adverse events | 1 / 4 | 3 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 |
Outcome results
Primary
Side Effects
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Time frame: about 1 week post infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Intravenous Infusion | Side Effects | 1.3 score on a scale | Standard Deviation 0.2 |
| Ketamine Intravenous Infusion | Side Effects | 1.4 score on a scale | Standard Deviation 0.7 |