Tobacco Use DisorderPhase 1/2SED-TUDNCT03813121
The Effects of Sedatives on Tobacco Use Disorder
A Phase 1/2 study testing midazolam intravenous infusion and ketamine intravenous infusion in people with Tobacco Use Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- midazolam intravenous infusion and ketamine intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Aug 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- smoke at least 5 cigarettes per day
- smoked at least 2 years
- negative urine drug screen for psychoactive drugs and negative breath alcohol concentration
- live in Little Rock AR or surrounding area
Who cannot join
- unstable or stable medical condition that would interact with study medication or participation
- serious head trauma or neurological disorder
- hypertension, abnormal ECG or metabolic blood results
- meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder
- use of psychoactive drugs or medications
- BMI > 40
- among women, pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.
- Conditions
- Tobacco Use Disorder
- Being tested
- midazolam intravenous infusion, placebo intravenous infusion, ketamine intravenous infusion
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam intravenous infusionDrug
Participants will receive a single drug infusion
placebo intravenous infusionDrug
Participants will receive a single placebo infusion
ketamine intravenous infusionDrug
Participants will receive a single drug infusion
| Study group | Role | What they receive |
|---|---|---|
| midazolam intravenous infusion | Experimental | single midazolam infusion (0.02 mg/kg over 20 minutes) Receives: Drug: midazolam intravenous infusion |
| placebo intravenous infusion | Placebo comparator | single placebo infusion (saline over 20 minutes) Receives: Drug: placebo intravenous infusion |
| ketamine intravenous infusion | Experimental | single ketamine infusion (0.5 mg/kg over 20 minutes) Receives: Drug: ketamine intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side Effects
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Measured: about 1 week post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jun 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merideth Addicott, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813121
- Sponsor's protocol ID
- IRB000229077
- Acronym
- SED-TUD
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2019
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuang J, Lide RC, Kamath N, Oliveto A, Addicott M. A pilot study of ketamine among individuals with tobacco use disorder: tolerability and initial impact on tobacco use outcomes. J Addict Dis. 2026 Jan-Mar;44(1):83-87. doi: 10.1080/10550887.2025.2450129. Epub 2025 Jan 20.
PubMed 39834135
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sedatives on Tobacco Use Disorder
- ClinicalTrials.gov ID
- NCT03813121
- Acronym / sponsor ID
- SED-TUD / IRB000229077
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 2 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam intravenous infusion | Experimental | Drug: midazolam intravenous infusionsingle midazolam infusion (0.02 mg/kg over 20 minutes) |
| placebo intravenous infusion | Placebo comparator | Drug: placebo intravenous infusionsingle placebo infusion (saline over 20 minutes) |
| ketamine intravenous infusion | Experimental | Drug: ketamine intravenous infusionsingle ketamine infusion (0.5 mg/kg over 20 minutes) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- smoke at least 5 cigarettes per day
- smoked at least 2 years
- negative urine drug screen for psychoactive drugs and negative breath alcohol concentration
- live in Little Rock AR or surrounding area
Key exclusion criteria (7 listed)
- unstable or stable medical condition that would interact with study medication or participation
- serious head trauma or neurological disorder
- hypertension, abnormal ECG or metabolic blood results
- meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder
- use of psychoactive drugs or medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolam intravenous infusionParticipants will receive a single drug infusion | Drug | midazolam intravenous infusion |
| placebo intravenous infusionParticipants will receive a single placebo infusion | Drug | placebo intravenous infusion |
| ketamine intravenous infusionParticipants will receive a single drug infusion | Drug | ketamine intravenous infusion |
Primary outcome
Side Effects
Time frame: about 1 week post infusion
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39834135Chuang J, Lide RC, Kamath N, Oliveto A, Addicott M. A pilot study of ketamine among individuals with tobacco use disorder: tolerability and initial impact on tobacco use outcomes. J Addict Dis. 2026 Jan-Mar;44(1):83-87. doi: 10.1080/10550887.2025.2450129. Epub 2025 Jan 20.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
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Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
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Young Adult Tobacco/Nicotine and Cannabis Co-use
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merideth Addicott, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing midazolam intravenous infusion and ketamine intravenous infusion in people with Tobacco Use Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side Effects (time frame: about 1 week post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03813121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.