Prescription StimulantsPhase 4NCT04635826
The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically
A Phase 4 study testing Adderall 10Mg Tablet in people with Prescription Stimulants and Expectations, run by University of Alabama at Birmingham.
Trial summary
We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Prescription Stimulants, Expectations, Deception
- What is being tested?
- Adderall 10Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Jul 2030
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old
- enrolled as a student at UAB or local college/university
- if female, willing to use adequate birth control or abstain from sexual activity
Who cannot join
- current or prior head injury
- current or prior psychiatric diagnosis (including ADHD)
- neurological disorder or stroke, hypertension, history of blood or circulation disorders (e.g., anemia or sickle-cell), diabetes, brain or spinal abnormalities
- blood pressure more than 130 systolic and 80 diastolic
- heart rate more than 100 beats per minute
- pregnancy
Show all 13Show fewer
- current illicit substance use as well as nicotine use
- Alcohol or cannabis use that meets DSM-5 criteria for an alcohol or cannabis use disorder
- Inability to abstain from alcohol or cannabis the night before and day of the scanning session
- Inability to reduce caffeine intake to less than 100 mg on testing days in heavy caffeine users
- claustrophobia
- hearing impairment
- vision impairment that cannot be corrected by MRI-compatible lenses
About this study
We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.
Read the detailed description
Participants will then be randomized in a balanced placebo design (BPD) crossing medication (10 mg of mixed amphetamine salts vs placebo) and expectancy (told active medication vs placebo medication), resulting in 4 different conditions 1) mixed amphetamine salts/told stimulant medication; 2) placebo/told stimulant medication; 3) mixed amphetamine salts/told placebo; and 4) placebo/told placebo). Participants will be assigned to four scanning sessions scheduled one week apart and will experience each condition once counterbalanced across participants. Participants will be administered cognitive tasks in and out of the scanner to determine the effects of medication vs expectancy.
- Conditions
- Prescription Stimulants, Expectations, Deception
- Being tested
- Adderall 10Mg Tablet, Placebo
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adderall 10Mg TabletDrug
Also called Adderall
Participants will be administered Adderall
PlaceboDrug
Participants will be administered placebo
| Study group | Role | What they receive |
|---|---|---|
| Adderall/Truth | Experimental | Participants will be told they are receiving Adderall and will actually be administered Adderall. Receives: Drug: Adderall 10Mg Tablet |
| Adderall/Deception | Experimental | Participants will be told they are receiving Adderall and will actually be administered placebo Receives: Drug: Placebo |
| Placebo/Truth | Placebo comparator | Participants will be told they are receiving placebo and will actually be administered placebo. Receives: Drug: Placebo |
| Placebo/Deception | Experimental | Participants will be told they are receiving placebo and will actually be administered Adderall Receives: Drug: Adderall 10Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
How expectancy will affect cognitive performance
Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. The main outcome measure is how the expectancy of stimulants will affect cognitive performance.
Measured: 120 minutes
The impact that stimulants vs. placebo have on the neural circuitry
Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. This outcome measure is to determine the impact stimulant administration and expectancy of stimulants have on the neural circuitry that supports sustained attention, inhibitory control, and verbal memory processes.
Measured: 120 minutes
Determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks
Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. This outcome measure is to determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks that support cognitive processes under investigation.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Why it stopped: Did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prescription StimulantsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 X 2, within-subjects, balanced placebo design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Cropsey, University of Alabama at Birmingham
- Investigators
- Karen Cropsey, PsyD, Principal investigator, University of Alabama at BirminghamDavid Knight, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635826
- Sponsor's protocol ID
- 300006362
- Status last verified
- Apr 2025
- First submitted
- 4 Nov 2020
- Last updated
- 7 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically
- ClinicalTrials.gov ID
- NCT04635826
- Acronym / sponsor ID
- 300006362
- Conditions
- Prescription Stimulants, Expectations, Deception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.
Detailed description
Participants will then be randomized in a balanced placebo design (BPD) crossing medication (10 mg of mixed amphetamine salts vs placebo) and expectancy (told active medication vs placebo medication), resulting in 4 different conditions 1) mixed amphetamine salts/told stimulant medication; 2) placebo/told stimulant medication; 3) mixed amphetamine salts/told placebo; and 4) placebo/told placebo). Participants will be assigned to four scanning sessions scheduled one week apart and will experience each condition once counterbalanced across participants. Participants will be administered cognitive tasks in and out of the scanner to determine the effects of medication vs expectancy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 2 X 2, within-subjects, balanced placebo design
| Arm | Type | Receives |
|---|---|---|
| Adderall/Truth | Experimental | Drug: Adderall 10Mg TabletParticipants will be told they are receiving Adderall and will actually be administered Adderall. |
| Adderall/Deception | Experimental | Drug: PlaceboParticipants will be told they are receiving Adderall and will actually be administered placebo |
| Placebo/Truth | Placebo comparator | Drug: PlaceboParticipants will be told they are receiving placebo and will actually be administered placebo. |
| Placebo/Deception | Experimental | Drug: Adderall 10Mg TabletParticipants will be told they are receiving placebo and will actually be administered Adderall |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-30 years old
- enrolled as a student at UAB or local college/university
- if female, willing to use adequate birth control or abstain from sexual activity
Key exclusion criteria (13 listed)
- current or prior head injury
- current or prior psychiatric diagnosis (including ADHD)
- neurological disorder or stroke, hypertension, history of blood or circulation disorders (e.g., anemia or sickle-cell), diabetes, brain or spinal abnormalities
- blood pressure more than 130 systolic and 80 diastolic
- heart rate more than 100 beats per minute
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 |
|---|---|---|
| Adderall 10Mg TabletAlso: AdderallParticipants will be administered Adderall | Drug | Adderall/Truth, Placebo/Deception |
| PlaceboParticipants will be administered placebo | Drug | Adderall/Deception, Placebo/Truth |
Primary outcome
How expectancy will affect cognitive performance
Time frame: 120 minutes
Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. The main outcome measure is how the expectancy of stimulants will affect cognitive performance.
The impact that stimulants vs. placebo have on the neural circuitry
Time frame: 120 minutes
Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. This outcome measure is to determine the impact stimulant administration and expectancy of stimulants have on the neural circuitry that supports sustained attention, inhibitory control, and verbal memory processes.
Determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks
Time frame: 120 minutes
Using a balanced placebo design, participants will be either administered mixed amphetamine salts or placebo. Their cognitive performance will be assessed in the MRI scanner. This outcome measure is to determine whether stimulant administration and expectancy for stimulants modify the functional connectivity of brain networks that support cognitive processes under investigation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2025.
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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.
Karen Cropsey, PsyD principal investigator
University of Alabama at Birmingham
David Knight, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adderall 10Mg Tablet in people with Prescription Stimulants and Expectations, run by University of Alabama at Birmingham.
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 3 inclusion and 13 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: withdrawn, as of the sponsor's last update on 7 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
How expectancy will affect cognitive performance (time frame: 120 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2025.