A Phase 4 interventional study of Adderall and Placebo in Expectancy Versus Pharmacotherapy Effect of Adderall, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Health services research
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.
University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be told they are receiving Adderall and will actually be administered Adderall.
Drug: Adderall
Participants will be told they are receiving placebo and will actually be administered placebo.
Drug: Placebo
Participants will be told they are receiving Adderall and will actually be administered placebo.
Drug: Placebo
Participants will be told they are receiving placebo and will actually be administered Adderall.
Drug: Adderall
Participants will be administered Adderall
Participants will be administered placebo
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.
Time frame: A total of 4 imagining sessions, an average of 60 minutes each
| Milestone | Adderall Within Subjects Design |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
| Milestone | Adderall Within Subjects Design |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
| Milestone | Adderall Within Subjects Design |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
| Milestone | Adderall Within Subjects Design |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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.
| Participants | Adderall/Truth | Placebo/Truth | Adderall/Deception | Placebo/Deception |
|---|---|---|---|---|
| Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions | 4 | 4 | 4 | 4 |
Collected over Baseline to one month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adderall/Truth | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Placebo/Truth | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Adderall/Deception | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Placebo/Deception | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Adderall Within Subjects Design |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Adderall Within Subjects Design |
|---|---|
| Female | 2 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Adderall Within Subjects Design |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Adderall Within Subjects Design |
|---|---|
| United States | 4 |
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University of Alabama at Birmingham