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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam intravenous infusion | Experimental | single midazolam infusion (0.02 mg/kg over 20 minutes) |
|
| placebo intravenous infusion | Placebo Comparator | single placebo infusion (saline over 20 minutes) |
|
| ketamine intravenous infusion | Experimental | single ketamine infusion (0.5 mg/kg over 20 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam intravenous infusion | Drug | Participants will receive a single drug infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | about 1 week post infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merideth Addicott, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39834135 | Derived | 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. |
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Participants must be screened for eligibility before being assigned to a group. Participants deemed ineligible were excluded from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Intravenous Infusion | single placebo infusion (saline over 20 minutes) placebo intravenous infusion: Participants will receive a single placebo infusion |
| FG001 | Ketamine Intravenous Infusion | single ketamine infusion (0.5 mg/kg over 20 minutes) ketamine intravenous infusion: Participants will receive a single drug infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Intravenous Infusion | single placebo infusion (saline over 20 minutes) placebo intravenous infusion: Participants will receive a single placebo infusion |
| BG001 | Ketamine Intravenous Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | about 1 week post infusion |
|
For 7 days post drug administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Intravenous Infusion | single placebo infusion (saline over 20 minutes) placebo intravenous infusion: Participants will receive a single placebo infusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Non-systematic Assessment |
The planned enrollment was 12 people. Investigator decided to complete the study early at 10 people because the principal investigator was leaving the institution and the logistics of running this remotely were too difficult. The last participant's last visit occurred, no new subjects were enrolled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Merideth Addicott | Wake Forest University School of Medicine | 336-716-7792 | maddicot@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2021 | Apr 11, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2021 | Sep 28, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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single-blind
| placebo intravenous infusion | Drug | Participants will receive a single placebo infusion |
|
| ketamine intravenous infusion | Drug | Participants will receive a single drug infusion |
|
single ketamine infusion (0.5 mg/kg over 20 minutes)
ketamine intravenous infusion: Participants will receive a single drug infusion
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Ketamine Intravenous Infusion | single ketamine infusion (0.5 mg/kg over 20 minutes) ketamine intravenous infusion: Participants will receive a single drug infusion | 0 | 6 | 0 | 6 | 3 | 6 |
| Emotional distress | General disorders | Non-systematic Assessment |
|
| motor incoordination | General disorders | Non-systematic Assessment |
|
| Tingling | General disorders | Non-systematic Assessment |
|
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