Differential Responses to Drugs and Sweet Tastes

NCT03810703 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB16-1293
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood elevation and heightened activity, are at risk for several psychiatric disorders, including problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major depression and schizophrenia. Recently, the investigators demonstrated in a controlled laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the current study, the investigators seek to extend these findings to determine if young adults reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards compared to healthy controls.

Conditions

Bipolar II Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).

  Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

  End of study (Baseline - time 0 and approximately 4 weeks later)

Study Arms (3)

placebo arm

PLACEBO COMPARATOR

Participant will receive placebo oral capsule during this four hour session.

Drug: Placebo oral capsule

amphetamine 10 mg arm

EXPERIMENTAL

Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.

Drug: d-amphetamine 10 mg oral capsule

amphetamine 20 mg arm

EXPERIMENTAL

Participant will receive d-amphetamine 20 mg oral capsule during this four hour session.

Drug: d-amphetamine 20 mg oral capsule

Interventions

Placebo oral capsule DRUG

Placebo oral capsule

placebo arm

d-amphetamine 10 mg oral capsule DRUG

d-amphetamine 10 mg oral capsule

amphetamine 10 mg arm

d-amphetamine 20 mg oral capsule DRUG

d-amphetamine 20 mg oral capsule

amphetamine 20 mg arm

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-19 years old
• BMI of 19-26
• Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine
• at least High School education
• Fluent in English

You may not qualify if:

• No Current Mood, Anxiety, Eating or Psychotic Disorder
• No current psychotropic medication
• No Recent Drug Dependence
• \< 4 alcoholic drinks/day for males; \< 3 alcoholic drinks/day for females (monthly average)
• No weekly (or more frequent) illicit drug use
• No women who are pregnant, nursing, or planning pregnancy within 3 months (birth control is okay)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (2)

University of Chicago Medical Center - Human Behavioral Pharmacology Lab

Chicago, Illinois, 60637, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Bipolar Disorder

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dave Arndt
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: January 22, 2019
• Study Start: February 9, 2017
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: February 22, 2023
• Results First Posted: February 22, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)