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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

Tracking Information
First Submitted Date  ICMJE August 1, 2017
First Posted Date  ICMJE January 21, 2019
Last Update Posted Date January 21, 2019
Actual Study Start Date  ICMJE February 9, 2017
Actual Primary Completion Date August 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Differential Responses to Drugs and Sweet Tastes
Official Title  ICMJE Hypomania, Amphetamine, and Preferences for Sweets
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Bipolar II Disorder
Intervention  ICMJE
  • Drug: Placebo oral capsule
    Placebo oral capsule
  • Drug: d-amphetamine 10 mg oral capsule
    d-amphetamine 10 mg oral capsule
  • Drug: d-amphetamine 20 mg oral capsule
    d-amphetamine 20 mg oral capsule
Study Arms  ICMJE
  • Placebo Comparator: placebo arm
    Participant will receive placebo oral capsule during this four hour session.
    Intervention: Drug: Placebo oral capsule
  • Experimental: amphetamine 10 mg arm
    Participant will receive d-amphetamine 10 mg oral capsule during this four hour session.
    Intervention: Drug: 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.
    Intervention: Drug: d-amphetamine 20 mg oral capsule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 9, 2018
Actual Primary Completion Date August 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 19 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810703
Other Study ID Numbers  ICMJE IRB16-1293
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP