Effects of sedatives on smoking behavior
The Effects of Sedatives on Tobacco Use Disorder Version 2
This study tests whether certain sedatives can help reduce cravings and smoking behavior in people who smoke but aren't looking for treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05505630 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of intravenous sedatives, including ketamine, midazolam, and dexmedetomidine, on cigarette smoking behavior and cravings in non-treatment seeking smokers. Participants will undergo a double-blind, placebo-controlled design, receiving one of the sedatives or a saline placebo at least two weeks apart. They will complete a 7-day ecological momentary assessment to track cravings, withdrawal symptoms, and smoking behavior before and after each infusion. Additionally, participants will undergo MRI scans to evaluate neural effects related to smoking and cravings.
Who should consider this trial
Good fit: Ideal candidates are daily cigarette smokers for at least two years who meet specific nicotine dependence criteria.
Not a fit: Patients with unstable medical conditions or significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with tobacco use disorder.
How similar studies have performed: Other studies have explored the effects of sedatives on addiction, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Merideth A Addicott, MD — Wake Forest University Health Sciences
- Study coordinator: Merideth Addicott
- Email: maddicot@wakeforest.edu
- Phone: 336-716-7792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.