Tobacco Smoking
Conditions
Keywords
nicotine addiction, smoking, placebo, sedatives
Brief summary
Double-blind, placebo-controlled, randomized mechanistic clinical trial to test an intravenous dose of either ketamine, midazolam, dexmedetomidine, or a placebo (saline) on cigarette smoking behavior, craving, and neural effects.
Detailed description
This double-blind, placebo-controlled, randomized mechanistic clinical trial will test non-treatment seeking smokers with an intravenous infusion of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or placebo, at least 2 weeks apart. Participants will complete 7-day ecological momentary assessment (EMA) of daily craving, withdrawal, and smoking behavior before and after each infusion. They will be asked to abstain from tobacco/nicotine for twenty-four hours post-infusion to induce withdrawal symptoms and return to the lab the following day to complete measures of craving, withdrawal, an MRI scan, and smoking latency. After this study visit, participants will be allowed to smoke as usual for the rest of the EMA diary period. Physical and subjective effects and adverse effects will be closely monitored throughout.
Interventions
DRUGKetamine
A single dose of IV ketamine will be administered.
DRUGMidazolam
A single dose of IV midazolam will be administered
DRUGDexmedetomidine
A single dose of IV dexmedetomidine will be administered
DRUGSaline
A single dose of IV saline will be administered
Sponsors
Wake Forest University Health Sciences
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Smokes cigarettes daily for at least 2 years * Afternoon expired breath carbon monoxide at least 5 ppm or morning urinary cotinine at least 100 ng/ml * Negative urine drug screen for psychoactive drugs and negative breath alcohol
Exclusion criteria
* Have an unstable medical condition or stable medical condition that would interact with study drug or participation, including chronic pulmonary disease, coronary artery disease, current brain tumor, current increased intracranial pressure or impaired consciousness * History of serious head trauma or neurological disorder (e.g., seizure disorder) * Have any of the following: hypertension (i.e., systolic \>140 mm Hg and/or diastolic \>90 mm Hg on three separate measures; systolic \>170 or diastolic \> 110 on any occasion), pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). * Use of drugs that would interact with study drug or increase risk of adverse events * Among women, pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in craving between drug and placebo | 24-hours post infusion | difference in self-reported craving for cigarettes after infusions |
| Difference in tobacco withdrawal symptoms | 24-hours post infusion | difference in self-reported withdrawal symptoms after infusions |
| Difference in cigarette demand | 24-hours post infusion | difference in self-reported cigarette demand after infusions |
| Number of cigarettes smoked ad lib | 24-hours post infusion | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMerideth A Addicott, MD
Wake Forest University Health Sciences
Outcome results
None listed