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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 weeks
Treatment ~ Varies
Follow Up ~24-hours post infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hours post infusion for reporting.

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 more

SED-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
~2110
Dexmedetomidine
2015
Completed Phase 4
~1980
Ketamine
2011
Completed Phase 4
~1120
Midazolam
2018
Completed Phase 4
~1910

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for tobacco smoking include nicotine replacement therapy (NRT), bupropion, and varenicline. NRT works by providing a controlled dose of nicotine to reduce withdrawal symptoms and cravings, aiding in gradual cessation. Bupropion, an atypical antidepressant, inhibits the reuptake of norepinephrine and dopamine, which helps reduce cravings and withdrawal symptoms. Varenicline, a selective nicotinic acetylcholine receptor agonist, reduces cravings and withdrawal by partially stimulating nicotine receptors and blocking nicotine from binding. NMDA receptor antagonists like ketamine are being studied for their potential to disrupt the neural pathways associated with addiction and craving, offering a novel approach to smoking cessation. Understanding these mechanisms is crucial for tailoring treatments to individual patients, potentially improving quit rates and reducing relapse.
Exploring Potential for a Personalized Medicine Approach to Smoking Cessation With an American Indian Tribe.Combination treatment for nicotine dependence: state of the science.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,880 Total Patients Enrolled
Merideth A Addicott, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05505630 — Phase < 1
Tobacco Smoking Research Study Groups: Saline first injection; ketamine second injection, Midazolam first injection; Saline second injection, Ketamine first injection; Saline second injection, Saline first injection; midazolam second injection, Dexmedetomidine first injection; Saline second injection, Saline first injection; dexmedetomidine second injection, Ketamine first injection; midazolam second injection, Ketamine first injection; dexmedetomidine second injection, Midazolam first injection; ketamine second injection, Midazolam first injection; dexmedetomidine second injection, Dexmedetomidine first injection; ketamine second injection, Dexmedetomidine first injection; midazolam second injection
Tobacco Smoking Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05505630 — Phase < 1
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05505630 — Phase < 1
~12 spots leftby Dec 2024