Differential Responses to Drugs and Sweet Tastes

Bipolar II Disorder Clinical Trial

— HAP  

Official title:

Hypomania, Amphetamine, and Preferences for Sweets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810703
• Other study ID #: IRB16-1293
• Status: Completed
• Phase: Phase 1
• Start date: February 9, 2017
• Est. completion date: August 9, 2018

Study information

• Verified date: May 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will extend the understanding of risk factors for drug or alcohol misuse, or other reward-related behaviors. The investigators previously showed that individuals who report occasional feelings of high energy and excitability experience less effect from a single dose of alcohol, compared to people who have not experienced these effects. Now the investigators wish to determine if this dampened response also occurs with other rewards, namely feelings of wellbeing after a dose of amphetamine, or liking of a sweet solution. Individuals who exhibit the BPP (i.e., periods of excitability) also are more likely to develop alcohol problems, substance misuse, and weight gain and obesity. Therefore, the investigators will test the working hypothesis that young adults who report having these experiences, based on a questionnaire measure (i.e., BPP individuals) will show dampened subjective responses to both single oral doses of amphetamine or sweet palatable tastes. The investigators will also obtain objective measures (e.g. Respiratory Sinus Arrhythmia and heart rate) to amphetamine and sweet taste, to establish whether the dampened subjective response extends to physiological indices as well. This study will extend the previous literature regarding the blunted effects of alcohol in BPP individuals and will suggest possible mechanisms that promote broader addictive behaviors in individuals with mood disturbance. Importantly, the investigators are proposing to test individuals at a relatively young age, 18-19 years. This is important to identify a risk factor, that is thought to pre-date use of drugs. In older participants, it would be difficult to separate the role of the pre-existing trait from the effect of habitual drug or alcohol use that escalates markedly after age 20.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 9, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 19 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Bipolar II Disorder

Intervention

Drug:
• Placebo oral capsule
Placebo oral capsule
• d-amphetamine 10 mg oral capsule
d-amphetamine 10 mg oral capsule
• d-amphetamine 20 mg oral capsule
d-amphetamine 20 mg oral capsule

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Chicago Medical Center - Human Behavioral Pharmacology Lab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Waleeprakhon P, Ittasakul P, Lotrakul M, Wisajun P, Jullagate S, Ketter TA. Development and validation of a screening instrument for bipolar spectrum disorder: The Mood Disorder Questionnaire Thai version. Neuropsychiatr Dis Treat. 2014 Aug 18;10:1497-502. doi: 10.2147/NDT.S67842. eCollection 2014. — View Citation

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White TL, Justice AJ, de Wit H. Differential subjective effects of D-amphetamine by gender, hormone levels and menstrual cycle phase. Pharmacol Biochem Behav. 2002 Nov;73(4):729-41. doi: 10.1016/s0091-3057(02)00818-3. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)