Role Of Sensitivity to neuroEndocrine Systems in Social Decisions (ROSES)

University of North Carolina (UNC)

Status and phase: Withdrawn; Phase 4

Conditions: Borderline Personality Disorder

Treatments: Drug: Hydrocortisone; Drug: Placebo; Dietary Supplement: Yohimbine

Study type: Interventional

Funder types: Other

Identifiers

NCT06018727

22-1839

Details and patient eligibility

About

The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making.

This study has two components. First, there will be an online session that participants complete to consent into the study, complete self-report surveys and a cognitive assessment, and confirm their eligibility for the second part of the study. If eligible to continue, participants will complete one in-person experiment session, during which they will complete self-report measures and a decision-making task. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine.

Full description

This study has two components. First, there will be a 60 minute online session. During this session, participants will first be asked to complete the informed consent process, a demographics and contact form, a series of questionnaires, a working memory assessment, and a HIPAA authorization. Researchers will also conduct a brief interview about the participant's medical history (including questions about mood, personality, and symptoms of borderline personality disorder), which is used to assess eligibility for participation in the study.

If eligible to continue, participants will complete one 90 minute in-person experiment session. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine. Ingesting hydrocortisone and yohimbine will increase participants' neuroendocrine (hormone) levels, which naturally become elevated in response to stress. After ingesting either the placebo or hydrocortisone plus yohimbine, participants will complete a series of questionnaires on a computer as well as an online decision-making task. While completing the computer task, participants' heart rate and pupil size activity will be monitored using an ECG monitor and an eye tracker. Three salivary samples will also be collected during this session: one immediately before participants ingest the placebo or hydrocortisone/yohimbine combination and two immediately before and after participants complete the computer game. These salivary samples will be collected, stored, then assayed, a process that allows us to measure participants' cortisol levels, a hormone important for the body's stress response.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Borderline Personality Disorder (BPD) group:

• Score of 38 or higher on PAI-BOR

• Participants in the BPD group will be primarily recruited from the two DEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the ROSES study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:

  1. 3+ BPD symptoms, one of which must be affective instability, per clinical interview
  2. Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).

Matched Control (MC) group:

• Score of 12 or lower on PAI-BOR
• Score below 50th percentile on WHODAS

Combined Inclusion Criteria:

• Ages 18-45
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
• Willingness to participate in all components of the study
• Access to necessary resources for participating in the virtual Session 1 (i.e., computer, smartphone, internet access)
• Participants must be able to speak, understand and read English.
• Participants must have at least 20/40 visual acuity (correct or uncorrected).

Exclusion criteria

• Current use of medications that interact adversely with yohimbine

  a. Iobenguane radiopharmaceutical products

• Current use of medications that interact adversely with hydrocortisone

  1. Aldesleukin
  2. Bacillus Calmette-Guérin (BCG) Products
  3. Cladribine
  4. Dengue Tetravalent Vaccine
  5. Desmopressin
  6. Indium 111 Capromab Pendetide
  7. Macimorelin
  8. Mifamurtide
  9. MiFEPRIStone
  10. Natalizumab
  11. Pimecrolimus:
  12. Ruxolitinib (Topical)
  13. Tacrolimus (Topical)
  14. Talimogene Laherparepvec
  15. Tertomotide
  16. Phenytoin
  17. Rifampin
  18. Troleandomycin
  19. Ketoconazole
  20. High-dose aspirin (>30 mg/kg/day)

• Contraindicated medical conditions of yohimbine

  1. Renal dysfunction
  2. Hepatic dysfunction
  3. Heart failure
  4. Psychotic Disorder or psychosis
  5. Hypotension
  6. Diabetes
  7. Heart disease
  8. Kidney disease
  9. Liver disease
  10. Nervous disorder
  11. Gastric ulcer
  12. Duodenal ulcer

• Contraindicated medical conditions of hydrocortisone

  1. Hypersensitivity to hydrocortisone or any component of the formulation
  2. Systemic fungal infections
  3. Latent Tuberculosis, Tuberculosis reactivity, active Tuberculosis
  4. Cardiovascular disease
  5. Diabetes
  6. Gastrointestinal diseases

  i. Diverticulitis ii. Fresh intestinal anastomoses iii. Active or latent peptic ulcer iv. Ulcerative colitis v. Abscess vi. Renal insufficiency vii. Other pyogenic infection g. Hepatic impairment h. Kidney impairment i. Myasthenia gravis j. Osteoporosis k. Pheochromocytoma l. Seizure disorders m. Septic shock or sepsis syndrome n. Systemic sclerosis o. Thyroid disease p. Strongyloides (threadworm) infestation q. Ocular herpes simplex r. Hypertension

• Given a live vaccine within 2 weeks of completing Visit 1. Recent administration of the following vaccines are specifically contraindicated for hydrocortisone:

  1. Typhoid Vaccine
  2. Yellow Fever Vaccine
  3. Poliovirus Vaccine (Live/Trivalent/Oral)
  4. Rubella- or Varicella-Containing Live Vaccines

• Have a current infection

• Pregnancy

• Individuals lactating

• Recent antihypertensive agents

• History of psychotic disorder, Bipolar I disorder, autism spectrum disorder, reactive attachment disorder, pervasive developmental disorder, motor disorder, head injury, mental retardation, neurological disorder, or current substance dependence

• Family history of Bipolar I disorder in a first degree relative.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Hydrocortisone + Yohimbine

Experimental group

Description:

Participants will ingest hydrocortisone and yohimbine during Session 2 approximately 10 minutes into the session.

Treatment:

Dietary Supplement: Yohimbine

Drug: Hydrocortisone

Placebo + Placebo

Placebo Comparator group

Description:

Participants will orally ingest two placebos during Session 2 approximately 10 minutes into the session.

Treatment:

Drug: Placebo