Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance

NCT03530631 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-300000343
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Expectancy Versus Pharmacotherapy Effect of Adderall

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Adderall/Truth

EXPERIMENTAL

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

Drug: Adderall

Placebo/Truth

PLACEBO COMPARATOR

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

Drug: Placebo

Adderall/Deception

EXPERIMENTAL

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

Drug: Placebo

Placebo/Deception

EXPERIMENTAL

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

Drug: Adderall

Interventions

Adderall DRUG

Participants will be administered Adderall

Adderall/Truth; Placebo/Deception

Placebo DRUG

Participants will be administered placebo

Adderall/Deception; Placebo/Truth

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age (18-24)
• College student with at least average IQ
• Willingness to standardize caffeine intake to 100 mg on day of study

You may not qualify if:

• 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
• Illicit stimulant use within the last year
• Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
• Uncontrolled medical illness
• Active contagious infection

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Adderall

Results Point of Contact

• Title: Karen Cropsey
• Organization: University of Alabama, Birmingham

kcropsey@uabmc.edu

(205) 975-7809

Study Officials

• Karen Cropsey, Psy.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 X 2, within-subjects, balanced placebo design

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 21, 2018
• Study Start: November 10, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: December 16, 2019
• Results First Posted: October 14, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)