Impact of stress on cannabis use motivation

Cannabinoids and Biological Reactivity to Stress

This study tests how different types of stress affect the desire to use cannabis in people with Cannabis Use Disorder to find new ways to help them.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Florida State University (Academic / other)
• Locations: 1 site (Tallahassee, Florida)
• Trial ID: NCT06430580 on ClinicalTrials.gov

What this trial studies

This study investigates how different forms of stress influence cannabis use motivation in individuals diagnosed with Cannabis Use Disorder (CUD). Participants will undergo a series of lab visits where they will receive either a placebo or one of two drugs that induce temporary stress-like symptoms. The study aims to understand the relationship between stress, cannabis motivation, and the body's natural cannabinoids by measuring brain activity and collecting blood samples. This research seeks to identify potential new treatment targets for CUD, addressing a significant public health need.

Who should consider this trial

Good fit: Ideal candidates are individuals with severe Cannabis Use Disorder who engage in daily cannabis use and can provide a urine sample positive for THC.

Not a fit: Patients with serious psychiatric issues or other substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to novel treatment strategies for individuals struggling with Cannabis Use Disorder.

How similar studies have performed: While there is limited research specifically targeting the effects of stress on cannabis motivation, studies on stress and substance use have shown promising results, suggesting this approach may yield valuable insights.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

  1. Angiotensin-Converting Enzyme (ACE) inhibitors including Lisinopril, Enalapril, Benazepril, and Bamipril
  2. Angiotensin II Receptor Blockers (ARB) including Losartan, Valsartan, and Olmesartan
  3. Thiazide Diuretics including Hydrochlorothiazide (HCTZ), Chlorthalidone
  4. Calcium Channel Blockers including Amlodipine, Diltiazem, and Verapamil
  5. Beta-blockers including Carvedilol, Metoprolol, Atenolol, Propranolol
  6. Anti-Arrythmic Medication including Disopyramide, Flecainide, and Mexiletine
  7. Edema (Diuretics)
  8. Thiazide Diuretics (as above)
  9. Loop Diuretics including Furosemide and Torsemide
  10. Potassium Sparing Diuretics: Spironolactone and Eplerenone
  11. 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.
* 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

Where this trial is running

Tallahassee, Florida

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

Study contacts

• Principal investigator: Richard J Macatee, PhD — Florida State University
• Study coordinator: Mallory Cannon, MS

Conditions Cannabis Use Disorder