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Differential Responses to Drugs and Sweet Tastes (HAP)

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ClinicalTrials.gov Identifier: NCT03810703
Recruitment Status : Completed
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Bipolar II Disorder Drug: Placebo oral capsule Drug: d-amphetamine 10 mg oral capsule Drug: d-amphetamine 20 mg oral capsule Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Hypomania, Amphetamine, and Preferences for Sweets
Actual Study Start Date : February 9, 2017
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo arm
Participant will receive placebo oral capsule during this four hour session.
Drug: Placebo oral capsule
Placebo oral capsule

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

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




Primary Outcome Measures :
  1. Addiction Research Center Inventory (ARCI-A) [ Time Frame: End of study (Baseline - time 0 and approximately 4 weeks later) ]
    The ARCI is a 49-item true-false scale that assesses participant sensitivity to several drug effect categories including: Amphetamine-like effects scale (e.g., increased energy, sense of well being), Benzedrine-like effects (e.g., increased energy, intellectual productivity), Morphine-Benzedrine-like effects (e.g., pleasant somatic experiences, euphoria), Lysergic Acid Diethylamide-like effects (e.g., dysphoria, somatic discomfort), and Pentobarbital-Chlorpromazine-Alcohol-like effects (e.g., sedation, psychomotor retardation). The primary measure in this study was the peak session rating on the Amphetamine Effects sub-scale



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Ages Eligible for Study:   18 Years to 19 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810703


Locations
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United States, Illinois
University of Chicago Medical Center - Human Behavioral Pharmacology Lab
Chicago, Illinois, United States, 60637
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03810703     History of Changes
Other Study ID Numbers: IRB16-1293
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors