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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo arm | Placebo Comparator | Participant will receive placebo oral capsule during this four hour session. |
|
| amphetamine 10 mg arm | Experimental | Participant will receive d-amphetamine 10 mg oral capsule during this four hour session. |
|
| amphetamine 20 mg arm | Experimental | Participant will receive d-amphetamine 20 mg oral capsule during this four hour session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral capsule | Drug | Placebo oral capsule |
| |
| d-amphetamine 10 mg oral capsule |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center - Human Behavioral Pharmacology Lab | Chicago | Illinois | 60637 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12716245 | Background | Calabrese JR, Hirschfeld RM, Reed M, Davies MA, Frye MA, Keck PE, Lewis L, McElroy SL, McNulty JP, Wagner KD. Impact of bipolar disorder on a U.S. community sample. J Clin Psychiatry. 2003 Apr;64(4):425-32. doi: 10.4088/jcp.v64n0412. | |
| 18595178 | Background | Chandler RA, Wang PW, Ketter TA, Goodwin GM. A new US-UK diagnostic project: mood elevation and depression in first-year undergraduates at Oxford and Stanford universities. Acta Psychiatr Scand. 2008 Jul;118(1):81-5. doi: 10.1111/j.1600-0447.2008.01193.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | Participant will receive placebo oral capsule during this four hour session. Placebo oral capsule: Placebo oral capsule |
| FG001 | Amphetamine 10 mg Arm | Participant will receive d-amphetamine 10 mg oral capsule during this four hour session. d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule |
| FG002 | Amphetamine 20 mg Arm | Participant will receive d-amphetamine 20 mg oral capsule during this four hour session. d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | Participant will receive placebo oral capsule during this four hour session. Placebo oral capsule: Placebo oral capsule |
| BG001 | Amphetamine 10 mg Arm | Participant will receive d-amphetamine 10 mg oral capsule during this four hour session. d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | End of study (Baseline - time 0 and approximately 4 weeks later) |
|
Through study completion, an average of 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Arm | Participant will receive placebo oral capsule during this four hour session. Placebo oral capsule: Placebo oral capsule |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Arndt | University of Chicago | 7737023560 | dewitlab@yoda.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2017 | May 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
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| Drug |
d-amphetamine 10 mg oral capsule |
|
| d-amphetamine 20 mg oral capsule | Drug | d-amphetamine 20 mg oral capsule |
|
| University of Chicago |
| Chicago |
| Illinois |
| 60637 |
| United States |
| 15333731 | Background | de Lauzon B, Romon M, Deschamps V, Lafay L, Borys JM, Karlsson J, Ducimetiere P, Charles MA; Fleurbaix Laventie Ville Sante Study Group. The Three-Factor Eating Questionnaire-R18 is able to distinguish among different eating patterns in a general population. J Nutr. 2004 Sep;134(9):2372-80. doi: 10.1093/jn/134.9.2372. |
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| 20822852 | Background | Hoeppner BB, Stout RL, Jackson KM, Barnett NP. How good is fine-grained Timeline Follow-back data? Comparing 30-day TLFB and repeated 7-day TLFB alcohol consumption reports on the person and daily level. Addict Behav. 2010 Dec;35(12):1138-43. doi: 10.1016/j.addbeh.2010.08.013. Epub 2010 Aug 13. |
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| 25170269 | Background | 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. |
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| 6779335 | Background | Johanson CE, Uhlenhuth EH. Drug preference and mood in humans: d-amphetamine. Psychopharmacology (Berl). 1980;71(3):275-9. doi: 10.1007/BF00433062. |
| 9107147 | Background | Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005. |
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| 27184339 | Background | Trost S, Diekhof EK, Mohr H, Vieker H, Kramer B, Wolf C, Keil M, Dechent P, Binder EB, Gruber O. Investigating the Impact of a Genome-Wide Supported Bipolar Risk Variant of MAD1L1 on the Human Reward System. Neuropsychopharmacology. 2016 Oct;41(11):2679-87. doi: 10.1038/npp.2016.70. Epub 2016 May 13. |
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| 27101084 | Background | Gontkovsky ST. Sensitivity of the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-II) to the neurocognitive deficits associated with the semantic dementia variant of frontotemporal lobar degeneration: A case study. Appl Neuropsychol Adult. 2017 May-Jun;24(3):288-293. doi: 10.1080/23279095.2016.1154857. Epub 2016 Apr 21. |
| 12213517 | Background | 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. |
| 22491350 | Background | Yip SW, Doherty J, Wakeley J, Saunders K, Tzagarakis C, de Wit H, Goodwin GM, Rogers RD. Reduced subjective response to acute ethanol administration among young men with a broad bipolar phenotype. Neuropsychopharmacology. 2012 Jul;37(8):1808-15. doi: 10.1038/npp.2012.45. Epub 2012 Apr 11. |
| BG002 | Amphetamine 20 mg Arm | Participant will receive d-amphetamine 20 mg oral capsule during this four hour session. d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education - High School Education | Count of Participants | Participants |
|
| OG001 | Amphetamine 10 mg Arm | Participant will receive d-amphetamine 10 mg oral capsule during this four hour session. d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule |
| OG002 | Amphetamine 20 mg Arm | Participant will receive d-amphetamine 20 mg oral capsule during this four hour session. d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Amphetamine 10 mg Arm | Participant will receive d-amphetamine 10 mg oral capsule during this four hour session. d-amphetamine 10 mg oral capsule: d-amphetamine 10 mg oral capsule | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Amphetamine 20 mg Arm | Participant will receive d-amphetamine 20 mg oral capsule during this four hour session. d-amphetamine 20 mg oral capsule: d-amphetamine 20 mg oral capsule | 0 | 31 | 0 | 31 | 0 | 31 |
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| D000588 |
| Amines |
| D009930 | Organic Chemicals |