Differential Responses to Drugs and Sweet Tastes (HAP)
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ClinicalTrials.gov Identifier: NCT03810703 |
Recruitment Status :
Completed
First Posted : January 22, 2019
Last Update Posted : January 22, 2019
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Sponsor:
University of Chicago
Information provided by (Responsible Party):
University of Chicago
Tracking Information | |||||||
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First Submitted Date ICMJE | August 1, 2017 | ||||||
First Posted Date ICMJE | January 22, 2019 | ||||||
Last Update Posted Date | January 22, 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 |
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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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 |
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Condition ICMJE | Bipolar II Disorder | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Chicago | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | University of Chicago | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
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 |