20 Participants Needed

Ketamine vs Midazolam for Tobacco Use Disorder

(SED-TUD2 Trial)

MA
Overseen ByMerideth Addicott
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different drugs affect smoking habits and cravings in people who are not trying to quit. Participants receive an injection of either ketamine, midazolam, dexmedetomidine, or a saltwater solution. The study aims to see if these drugs can help reduce cravings and withdrawal symptoms.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those using drugs that would interact with the study drug or increase the risk of adverse events. It's best to discuss your current medications with the trial team.

How is ketamine unique as a drug for treating tobacco use disorder?

Ketamine is unique for treating tobacco use disorder because it acts rapidly on the brain's NMDA receptors, which are involved in mood and addiction pathways, potentially offering quick relief from cravings. This mechanism is different from traditional treatments like nicotine replacement therapies or behavioral interventions, which do not target these specific brain receptors.12345

What evidence supports the effectiveness of the drug ketamine for treating tobacco use disorder?

Research suggests that ketamine has shown promise in treating addictions, such as alcohol and opiate dependence, and has been effective in psychiatric conditions like depression. This indicates potential for ketamine in treating tobacco use disorder, although specific studies on tobacco are not mentioned.678910

Who Is on the Research Team?

MA

Merideth A Addicott, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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
Smokes cigarettes daily for at least 2 years

Exclusion 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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusions of either ketamine, midazolam, dexmedetomidine, or placebo, with a 7-day ecological momentary assessment of craving, withdrawal, and smoking behavior before and after each infusion.

2 weeks per infusion cycle
Multiple visits for infusions and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of craving, withdrawal, MRI scan, and smoking latency.

24 hours post-infusion
1 visit (in-person) for follow-up assessments

Long-term follow-up

Participants may be monitored for any long-term effects or adverse events after the completion of the main trial phases.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
  • Midazolam
Trial Overview 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.
How Is the Trial Designed?
12Treatment groups
Experimental Treatment
Group I: Saline first injection; midazolam second injectionExperimental Treatment2 Interventions
Group II: Saline first injection; ketamine second injectionExperimental Treatment2 Interventions
Group III: Saline first injection; dexmedetomidine second injectionExperimental Treatment2 Interventions
Group IV: Midazolam first injection; ketamine second injectionExperimental Treatment2 Interventions
Group V: Midazolam first injection; dexmedetomidine second injectionExperimental Treatment2 Interventions
Group VI: Midazolam first injection; Saline second injectionExperimental Treatment2 Interventions
Group VII: Ketamine first injection; midazolam second injectionExperimental Treatment2 Interventions
Group VIII: Ketamine first injection; dexmedetomidine second injectionExperimental Treatment2 Interventions
Group IX: Ketamine first injection; Saline second injectionExperimental Treatment2 Interventions
Group X: Dexmedetomidine first injection; midazolam second injectionExperimental Treatment2 Interventions
Group XI: Dexmedetomidine first injection; ketamine second injectionExperimental Treatment2 Interventions
Group XII: Dexmedetomidine first injection; Saline second injectionExperimental Treatment2 Interventions

Ketamine is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Ketalar for:
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Approved in European Union as Ketalar for:
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Approved in United States as Spravato for:
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Approved in European Union as Spravato for:
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Approved in Canada as Spravato for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Nida Addiction Research Center

Collaborator

Trials
1
Recruited
50+

Published Research Related to This Trial

Ketamine has shown potential benefits in treating psychiatric conditions like major depression and in supporting abstinence from alcohol and opiates, based on a literature review of studies from 2003 to 2013.
Despite its promising therapeutic effects, ketamine poses a risk of abuse and dependence, leading to various somatic, psychiatric, and cognitive complications, highlighting the need for careful consideration in its use.
[Ketamine: psychiatric indications and misuses].Delimbeuf, N., Petit, A., Karila, L., et al.[2015]
Chronic ketamine users exhibit significant impairments in verbal and visual memory, while their working memory and executive functions remain intact, based on a study involving 286 non-heavy and 279 heavy other drug users compared to 261 healthy controls.
The study found that the frequency and dosage of ketamine use correlate with worse memory performance, particularly in visual memory for non-heavy users and short-term verbal memory for heavy users, indicating that increased ketamine use negatively affects specific cognitive functions.
Other drug use does not impact cognitive impairments in chronic ketamine users.Zhang, C., Tang, WK., Liang, HJ., et al.[2019]
Oral ketamine has shown effectiveness in treating severe depression, including treatment-resistant cases and those with suicidal ideation, based on various studies including randomized controlled trials with doses ranging from 0.25 to 7 mg/kg.
Despite its lower bioavailability (20%-25% reaching the bloodstream), oral ketamine is well tolerated and can be adjusted for individual needs, making it a practical option for depression treatment alongside conventional antidepressants.
Oral Ketamine for Depression, 1: Pharmacologic Considerations and Clinical Evidence.Andrade, C.[2019]

Citations

[Ketamine: psychiatric indications and misuses]. [2015]
Other drug use does not impact cognitive impairments in chronic ketamine users. [2019]
Oral Ketamine for Depression, 1: Pharmacologic Considerations and Clinical Evidence. [2019]
Ketamine psychedelic therapy (KPT): a review of the results of ten years of research. [2022]
Longitudinal trajectories of ketamine use among young injection drug users. [2023]
Low- versus high-dose combination of midazolam-ketamine for oral premedication in children for ophthalmologic surgeries. [2022]
Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial. [2022]
Evaluation of the use of midazolam as a co-induction agent with ketamine for anaesthesia in sedated ponies undergoing field castration. [2022]
An alternative to "brutacaine": a comparison of low dose intramuscular ketamine with intranasal midazolam in children before suturing. [2022]
Impact of midazolam vs. saline on effect size estimates in controlled trials of ketamine as a rapid-acting antidepressant. [2021]
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