Expectancy Versus Pharmacotherapy Effect of AdderallPhase 4NCT03530631
Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
A Phase 4 study testing Adderall in people with Expectancy Versus Pharmacotherapy Effect of Adderall, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Expectancy Versus Pharmacotherapy Effect of Adderall
- What is being tested?
- Adderall
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2018to 18 Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age (18-24)
- College student with at least average IQ
- Willingness to standardize caffeine intake to 100 mg on day of study
Who cannot join
- Attention Deficit/Hyperactivity Disorder (ADHD)
- First degree relative with ADHD
- Unwillingness to comply with caffeine specifications
- Regular use of Adderall
- Pregnant/breastfeeding
- History of substance use disorders
Show all 10Show fewer
- Illicit stimulant use within the last year
- Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
- Uncontrolled medical illness
- Active contagious infection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the detailed description
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.
- Being tested
- Adderall, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdderallDrug
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 |
| Placebo/Truth | Placebo comparator | Participants will be told they are receiving placebo and will actually be administered placebo. Receives: Drug: Placebo |
| Adderall/Deception | Experimental | Participants will be told they are receiving Adderall 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A total of 4 imagining sessions, an average of 60 minutes each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start10 Nov 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Expectancy Versus Pharmacotherapy Effect of AdderallStudies 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
- 4 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, Psy.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530631
- Sponsor's protocol ID
- IRB-300000343
- Status last verified
- Dec 2019
- First submitted
- 24 Apr 2018
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
- ClinicalTrials.gov ID
- NCT03530631
- Acronym / sponsor ID
- IRB-300000343
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Posted 14 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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: AdderallParticipants will be told they are receiving Adderall and will actually be administered Adderall. |
| Placebo/Truth | Placebo comparator | Drug: PlaceboParticipants will be told they are receiving placebo and will actually be administered placebo. |
| Adderall/Deception | Experimental | Drug: PlaceboParticipants will be told they are receiving Adderall and will actually be administered placebo. |
| Placebo/Deception | Experimental | Drug: AdderallParticipants will be told they are receiving placebo and will actually be administered Adderall. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age (18-24)
- College student with at least average IQ
- Willingness to standardize caffeine intake to 100 mg on day of study
Key exclusion criteria (10 listed)
- Attention Deficit/Hyperactivity Disorder (ADHD)
- First degree relative with ADHD
- Unwillingness to comply with caffeine specifications
- Regular use of Adderall
- Pregnant/breastfeeding
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 |
|---|---|---|
| AdderallParticipants will be administered Adderall | Drug | Adderall/Truth, Placebo/Deception |
| PlaceboParticipants will be administered placebo | Drug | Adderall/Deception, Placebo/Truth |
Primary outcome
Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions
Time frame: A total of 4 imagining sessions, an average of 60 minutes each
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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, Psy.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adderall in people with Expectancy Versus Pharmacotherapy Effect of Adderall, run by University of Alabama at Birmingham at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions (time frame: A total of 4 imagining sessions, an average of 60 minutes each). 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 16 Dec 2019.