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| ID | Type | Description | Link |
|---|---|---|---|
| R03DA054098-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Nicotine Expectancy, Reduced Nicotine Dose | Experimental | Receive reduced nicotine cigarette expecting full |
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| Full Nicotine Expectancy, Full Nicotine Dose | Experimental | Receive full nicotine cigarette expecting full |
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| Reduced Nicotine Expectancy, Full Nicotine Dose | Experimental | Receive full nicotine cigarette expecting reduced |
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| Reduced Nicotine Expectancy, Reduced Nicotine Dose | Experimental | Receive reduced nicotine cigarette expecting reduced |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Nicotine Cigarettes | Drug | A full nicotine tobacco cigarette that will be smoked by participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Demand Intensity | Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome). | Four times over approximately two weeks |
| Demand Elasticity | Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated) | Four times over approximately two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale | A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). | Post-cigarette administration four times over approximately two weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Johnson | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Included in Analysis | This study used a within subjects design (i.e., all subjects were to receive all conditions, full and reduced nicotine tobacco cigarette). Twenty-one subjects completed the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Included in Analysis | This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Demand Intensity | Consumption of cigarettes at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more cigarette consumption at unconstrained price (a worse outcome). | Posted | Mean | Standard Error | cigarettes | Four times over approximately two weeks |
|
|
Approximately two weeks
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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 | Subjects Included in Analysis | This study used a within subjects design (i.e., all subjects were to receive all conditions). Twenty-one subjects completed the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin Strickland | Johns Hopkins University School of Medicine | 4105501975 | jstric14@jhmi.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 | Oct 19, 2022 | Jan 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2021 | Jan 12, 2024 | 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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| Reduced Nicotine Cigarettes | Drug | A reduced nicotine tobacco cigarette that will be smoked by participants |
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| Average Nicotine Expectancy | Behavioral | Participant instructed the cigarette is "the same level of nicotine as your usual brand." |
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| Very Low Nicotine Expectancy | Behavioral | Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand." |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Demand Elasticity | Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome). Values are log-transformed. Data are presented for all subjects with non-zero data (zero data cannot be analyzed with a demand function so elasticity cannot be generated) | Data are presented for all subjects with non-zero data | Posted | Mean | Standard Deviation | log(cigarettes/dollar) | Four times over approximately two weeks |
|
|
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| Secondary | Minnesota Nicotine Withdrawal Scale | A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). | Posted | Mean | Standard Deviation | units on a scale | Post-cigarette administration four times over approximately two weeks |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| Condition C: Told Reduced, Received Full |
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| Condition D: Told Reduced, Received Reduced |
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| Title | Measurements |
|---|---|
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| Condition D: Told Reduced, Received Reduced |
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