RECRUITING

Cannabinoids and Biological Reactivity to Stress

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to test the impact of two drugs that produce temporary stress-like symptoms, both in isolation and together, on cannabis use motivation in individuals with Cannabis Use Disorder. The main questions it will answer are: 1. How do different forms of stress affect cannabis use motivation? 2. How do different forms of stress affect the body's natural cannabinoids? Researchers will compare a placebo to both drugs in isolation, as well as together, across four separate lab visits. Participants will: 1\) Complete a clinical screening interview (by phone or in-person) and visit the lab for a medical screening, and if eligible: a) Visit the lab four times where they will: i). Take one of four drug combinations ii). Complete an interview, questionnaires, and computerized tasks iii). Have their brain activity recorded with an EEG cap iv). Provide three blood samples

Official Title

Cannabinoids and Biological Reactivity to Stress

Quick Facts

Study Start:2024-09-30
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06430580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets criteria for current, moderate to severe Cannabis Use Disorder (CUD) as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview.
  2. * Reports engagement in near-daily/daily cannabis use.
  3. * Provide a urine sample positive for THC.
  4. * Must be in generally good health as determined by a physical exam, EKG, and blood tests
  5. * Must be adequately informed of the nature and risks of the study and given written informed consent prior to screening.
  6. * Able to read and write in English.
  1. * Has a history of serious psychiatric problems (i.e., psychosis, Bipolar Disorder I) or meets criteria for a current Major Depressive Episode, as assessed by the SCID-V-RV.
  2. * Reports current suicidal ideation.
  3. * Meets DSM-5 criteria for any other current, moderate to severe substance use disorder (other than CUD or Tobacco Use Disorder
  4. * Has a positive result urine drug screen for all other drugs aside from THC (i.e., amphetamine, methamphetamine, benzodiazepine, cocaine, MDMA, morphine, oxycodone, methadone, buprenorphine) at screening or at any lab visit.
  5. * Has structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, a history of other neurological diseases, or a history of head trauma resulting in unconsciousness.
  6. * Has a history of cardiovascular disease, myocardial infarction, chest pain, or palpitations on exertion or drug use, edema, hypertension, resting heart rate \<50 BPM or \>100 BPM. Cardiovascular diseases include:
  7. * Demonstrates systolic BP outside of acceptable range (80-140mmHG), or diastolic BP outside of acceptable range (50-90 mmHG)
  8. * Has a history of cor pulmonale, dyspnea, orthopnea, tachypnea (\>24 breaths per minute), or uncontrolled chronic obstructive pulmonary disease or asthma.
  9. * Currently taking any daily psychotropic medication
  10. * Currently taking any of the following medications:
  11. 1. Angiotensin-Converting Enzyme (ACE) inhibitors including Lisinopril, Enalapril, Benazepril, and Bamipril
  12. 2. Angiotensin II Receptor Blockers (ARB) including Losartan, Valsartan, and Olmesartan
  13. 3. Thiazide Diuretics including Hydrochlorothiazide (HCTZ), Chlorthalidone
  14. 4. Calcium Channel Blockers including Amlodipine, Diltiazem, and Verapamil
  15. 5. Beta-blockers including Carvedilol, Metoprolol, Atenolol, Propranolol
  16. 6. Anti-Arrythmic Medication including Disopyramide, Flecainide, and Mexiletine
  17. 7. Edema (Diuretics)
  18. 8. Thiazide Diuretics (as above)
  19. 9. Loop Diuretics including Furosemide and Torsemide
  20. 10. Potassium Sparing Diuretics: Spironolactone and Eplerenone
  21. 11. Anti-Platelet Medications such as Clopidogrel, Prasugrel, and Ticagrelor
  22. * Reproductively capable candidates who are pregnant (based on urine test at screening or at any lab visit) or are heterosexually active and not using medically approved birth control measures (oral contraceptives, IUD, condom, sterilization).
  23. * Self-reports currently seeking or engaging in CUD treatment or any other alcohol or drug treatment.
  24. * Self-reports intent to imminently quit cannabis use.
  25. * Has a Blood-Injection-Injury Phobia, as determined by scores greater than 15 on the Injection and Blood Draw subscale of the Medical Fear Survey

Contacts and Locations

Study Contact

Mallory Cannon, MS
CONTACT
850-644-2445
brains@psy.fsu.edu

Principal Investigator

Richard J Macatee, PhD
PRINCIPAL_INVESTIGATOR
Florida State University

Study Locations (Sites)

The BRAINS Lab at Florida State University
Tallahassee, Florida, 32306-4301
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Richard J Macatee, PhD, PRINCIPAL_INVESTIGATOR, Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cannabis Use Disorder