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The purpose of this balanced-placebo design study is to pilot a larger study to further explore the current evidence that stimulant medications are not cognitive enhancers, despite this rampant belief in young adults. While the lack of cognitive enhancement from stimulant medication has been documented in prior research, this study is the first to utilize neuroimaging technology to examine brain regions activated during neurocognitive tasks when participants believe they have been administered stimulant medication or placebo.
This is a 2 X 2 within subjects, balanced placebo design and all participants will experience each of the four conditions during four sequential weeks. Medication administered (Adderall vs. placebo) is crossed with instructional set (truth vs. deception) and participants' performance on neurocognitive tasks is compared across these groups. For example, participants are either given stimulant medication or placebo, and are either accurately told or inaccurately told that they received stimulant medication or placebo. Neuroimaging is being utilized to investigate whether participants' expectations regarding the benefits of stimulant medication affects their performance on neurocognitive tasks. The hypothesis of the study is that participants' expectations regarding stimulant medication will affect their performance on neurocognitive tasks, rather than the actual effect of the medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adderall/Truth | Experimental | Participants will be told they are receiving Adderall and will actually be administered Adderall. |
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| Placebo/Truth | Placebo Comparator | Participants will be told they are receiving placebo and will actually be administered placebo. |
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| Adderall/Deception | Experimental | Participants will be told they are receiving Adderall and will actually be administered placebo. |
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| Placebo/Deception | Experimental | Participants will be told they are receiving placebo and will actually be administered Adderall. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adderall | Drug | Participants will be administered Adderall |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | Using a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions. | A total of 4 imagining sessions, an average of 60 minutes each |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Cropsey, Psy.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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Only four subjects were recruited for this pilot study
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| ID | Title | Description |
|---|---|---|
| FG000 | Adderall Within Subjects Design | This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adderall/Truth |
| |||||||||||||
| Placebo/Truth |
| |||||||||||||
| Adderall/Deception |
| |||||||||||||
| Placebo/Deception |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adderall Within Subjects Design | This is a within-subjects design in which participants will complete all four periods/conditions. For two sessions, participants will be accurately told that they are receiving Adderall or placebo, respectively. For two sessions, participants will be inaccurately informed that they are receiving Adderall or placebo. The participants will be counterbalanced across conditions to control for order effects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | Using a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions. | Posted | Count of Participants | Participants | A total of 4 imagining sessions, an average of 60 minutes each |
|
Baseline to one month
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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 | Adderall/Truth | Participants will be told they are receiving Adderall and will actually be administered Adderall. Adderall: Participants will be administered Adderall |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Cropsey | University of Alabama, Birmingham | (205) 975-7809 | kcropsey@uabmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2019 | Dec 4, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C090411 | Adderall |
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2 X 2, within-subjects, balanced placebo design
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This will be a double-blind study. Research assistants will administer capsules, and based on package labeling, tell the participant if they are being administered Adderall or placebo. However, researchers and participants will be blind to which medication is actually being administered.
| Placebo | Drug | Participants will be administered placebo |
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Adderall/Deception | Participants will be told they are receiving Adderall and will actually be administered placebo. Placebo: Participants will be administered placebo |
| OG003 | Placebo/Deception | Participants will be told they are receiving placebo and will actually be administered Adderall. Adderall: Participants will be administered Adderall |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo/Truth | Participants will be told they are receiving placebo and will actually be administered placebo. Placebo: Participants will be administered placebo | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Adderall/Deception | Participants will be told they are receiving Adderall and will actually be administered placebo. Placebo: Participants will be administered placebo | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Placebo/Deception | Participants will be told they are receiving placebo and will actually be administered Adderall. Adderall: Participants will be administered Adderall | 0 | 4 | 0 | 4 | 0 | 4 |
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