The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

NCT ID: NCT04635826

Last Updated: 2025-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2030-07-31

Brief Summary

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We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.

Detailed Description

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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

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Prescription Stimulants Expectations Deception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2 X 2, within-subjects, balanced placebo design
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Adderall/Truth

Participants will be told they are receiving Adderall and will actually be administered Adderall.

Group Type EXPERIMENTAL

Adderall 10Mg Tablet

Intervention Type DRUG

Participants will be administered Adderall

Adderall/Deception

Participants will be told they are receiving Adderall and will actually be administered placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Participants will be administered placebo

Placebo/Truth

Participants will be told they are receiving placebo and will actually be administered placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be administered placebo

Placebo/Deception

Participants will be told they are receiving placebo and will actually be administered Adderall

Group Type EXPERIMENTAL

Adderall 10Mg Tablet

Intervention Type DRUG

Participants will be administered Adderall

Interventions

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Adderall 10Mg Tablet

Participants will be administered Adderall

Intervention Type DRUG

Placebo

Participants will be administered placebo

Intervention Type DRUG

Other Intervention Names

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Adderall

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Karen Cropsey

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Cropsey, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

David Knight, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

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300006362

Identifier Type: -

Identifier Source: org_study_id

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