Cannabinoids and Biological Reactivity to Stress

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Cannabis Use Disorder

In brief

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

Key facts

Study ID

NCT06430580

Run by

Florida State University

People needed

36

Starts

2024-09-30

Expected to finish

2026-09-30

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Reports engagement in near-daily/daily cannabis use.
• Provide a urine sample positive for THC.
• Must be in generally good health as determined by a physical exam, EKG, and blood tests
• Must be adequately informed of the nature and risks of the study and given written informed consent prior to screening.
• Able to read and write in English.

You may not qualify if…

• 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.
• Reports current suicidal ideation.
• Meets DSM-5 criteria for any other current, moderate to severe substance use disorder (other than CUD or Tobacco Use Disorder
• 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.
• 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.
• 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:
• . a. Benign prostatic hyperplasia (BPH) b. Post-myocardial infarction
• Demonstrates systolic BP outside of acceptable range (80-140mmHG), or diastolic BP outside of acceptable range (50-90 mmHG)
• Has a history of cor pulmonale, dyspnea, orthopnea, tachypnea (>24 breaths per minute), or uncontrolled chronic obstructive pulmonary disease or asthma.
• Currently taking any daily psychotropic medication
• Currently taking any of the following medications:
• Angiotensin-Converting Enzyme (ACE) inhibitors including Lisinopril, Enalapril, Benazepril, and Bamipril
• Angiotensin II Receptor Blockers (ARB) including Losartan, Valsartan, and Olmesartan
• Thiazide Diuretics including Hydrochlorothiazide (HCTZ), Chlorthalidone
• Calcium Channel Blockers including Amlodipine, Diltiazem, and Verapamil
• Beta-blockers including Carvedilol, Metoprolol, Atenolol, Propranolol
• Anti-Arrythmic Medication including Disopyramide, Flecainide, and Mexiletine
• Edema (Diuretics)
• Thiazide Diuretics (as above)
• Loop Diuretics including Furosemide and Torsemide
• Potassium Sparing Diuretics: Spironolactone and Eplerenone
• Anti-Platelet Medications such as Clopidogrel, Prasugrel, and Ticagrelor
• 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).
• Self-reports currently seeking or engaging in CUD treatment or any other alcohol or drug treatment.
• Self-reports intent to imminently quit cannabis use.

Where it is running

• The BRAINS Lab at Florida State University — Tallahassee, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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