Your session is about to expire
← Back to Search
NMDA Receptor Antagonist
Ketamine vs Midazolam for Tobacco Use Disorder (SED-TUD2 Trial)
Phase < 1
Recruiting
Led By Merideth A Addicott, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-hours post infusion
Awards & highlights
SED-TUD2 Trial Summary
This trial tests a potential drug (ketamine) to reduce cigarette smoking cravings and effect the brain, compared to an existing drug (midazolam).
Who is the study for?
This trial is for daily cigarette smokers of at least 2 years, with specific levels of carbon monoxide or cotinine in their breath/urine and no recent use of psychoactive drugs. It excludes those with serious head trauma, certain mental health conditions, unstable medical issues, pregnant or breastfeeding women, extreme obesity, poor vision not correctable to 20/40, severe hypertension or liver/kidney dysfunction.Check my eligibility
What is being tested?
The study tests the effects of sedatives (ketamine, midazolam, dexmedetomidine) versus a placebo (saline) on smoking behavior and cravings. Participants are randomly assigned to receive one treatment intravenously without knowing which one they get—a method known as double-blind.See study design
What are the potential side effects?
Potential side effects from the sedatives may include drowsiness, changes in blood pressure and heart rate; mood alterations; nausea; potential for abuse with ketamine; memory impairment particularly with midazolam; dry mouth and possible withdrawal symptoms.
SED-TUD2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-hours post infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-hours post infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in cigarette demand
Pharmaceutical Preparations
Difference in tobacco withdrawal symptoms
+1 moreSED-TUD2 Trial Design
12Treatment groups
Experimental Treatment
Group I: Saline first injection; midazolam second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion midazolam at the second injection visit
Group II: Saline first injection; ketamine second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
Group III: Saline first injection; dexmedetomidine second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
Group IV: Midazolam first injection; ketamine second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
Group V: Midazolam first injection; dexmedetomidine second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
Group VI: Midazolam first injection; Saline second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion placebo at the second injection visit.
Group VII: Ketamine first injection; midazolam second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.
Group VIII: Ketamine first injection; dexmedetomidine second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
Group IX: Ketamine first injection; Saline second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion placebo at the second injection visit.
Group X: Dexmedetomidine first injection; midazolam second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.
Group XI: Dexmedetomidine first injection; ketamine second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
Group XII: Dexmedetomidine first injection; Saline second injectionExperimental Treatment2 Interventions
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion placebo at the second injection visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2013
Completed Phase 4
~1050
Dexmedetomidine
2015
Completed Phase 4
~1980
Ketamine
2011
Completed Phase 4
~1090
Midazolam
2018
Completed Phase 4
~1910
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,185 Total Patients Enrolled
Merideth A Addicott, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that could affect the study treatment.I have had a serious head injury or a neurological condition like seizures.I am not pregnant or breastfeeding.I am not taking any medications that could interfere with the study drug.I have high blood pressure or a severe narrowing in my digestive tract.
Research Study Groups:
This trial has the following groups:- Group 1: Midazolam first injection; Saline second injection
- Group 2: Ketamine first injection; Saline second injection
- Group 3: Dexmedetomidine first injection; Saline second injection
- Group 4: Saline first injection; ketamine second injection
- Group 5: Saline first injection; dexmedetomidine second injection
- Group 6: Saline first injection; midazolam second injection
- Group 7: Ketamine first injection; midazolam second injection
- Group 8: Ketamine first injection; dexmedetomidine second injection
- Group 9: Midazolam first injection; ketamine second injection
- Group 10: Midazolam first injection; dexmedetomidine second injection
- Group 11: Dexmedetomidine first injection; ketamine second injection
- Group 12: Dexmedetomidine first injection; midazolam second injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the elderly being included in this clinical trial's recruitment of participants?
"Those between 21 and 55 years of age are qualified to participate in this research."
Answered by AI
Are there any vacancies available for those wishing to take part in this clinical trial?
"Affirmative, the information posted on clinicaltrials.gov denotes that this research is currently recruiting participants. The trial was initially launched on January 31st 2023 and has been most recently updated on February 24th of the same year. This endeavour requires a total of 52 individuals to be recruited from one medical centre."
Answered by AI
Is participation in this medical experiment open to the public?
"This clinical study is seeking applicants aged 21 to 55 who have a minimum of two years' worth of daily smoking experience. Eligible participants must also possess afternoons expired breath carbon monoxide levels at least 5 ppm or morning urinary cotinine concentrations at least 100 ng/ml, and test negative for psychoactive drugs and alcohol on urinalysis screens."
Answered by AI
Who else is applying?
What state do they live in?
New York
North Carolina
Other
Tennessee
What site did they apply to?
Wake Forest University Health Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
Need the money and want to stop smoking. I have tried patches and hypnosis. Works for about a month then I get frustrated. I live alone and am in constant pain and immobile. Lots of challenges. Last thing I need is to continue to smoke. Please help me! Thank you!
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long will the screenings take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Wake Forest University Health Sciences: < 24 hours
Average response time
- < 1 Day
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger