Cannabinoids and Biological Reactivity to Stress

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06430580
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Hydrocortisone Oral — DRUG
    20mg hydrocortisone, single oral dose
  • Yohimbine Hydrochloride — DRUG
    54mg yohimbine hcl, single oral dose
  • Cornstarch Placebo 20mg — DRUG
    20mg cornstarch placebo, single oral dose
  • Cornstarch Placebo 54mg — DRUG
    54mg cornstarch placebo, single oral dose

Study Details

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 Dates

Start date
Sep 30, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 20mg hydrocortisone + 54mg yohimbine hcl
    20mg hydrocortisone, single oral dose 54mg yohimbine hcl, single oral dose
  • Experimental: 20mg hydrocortisone + 54mg placebo
    20mg hydrocortisone, single oral dose 54mg cornstarch placebo, single oral dose
  • Active Comparator: 20mg placebo + 54mg yohimbine hcl
    20mg cornstarch placebo, single oral dose 54mg yohimbine hcl, single oral dose
  • Placebo Comparator: 20mg placebo + 54mg placebo
    20mg cornstarch placebo, single oral dose 54mg cornstarch placebo, single oral dose

Primary Outcome Measure

Amplitude of neurophysiological response to cannabis cues (μV) [ Time Frame: Late positive potential amplitude outcome is assessed at each of the four lab visits, which take place over the study period (10-22 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The BRAINS Lab at Florida State UniversityTallahasseeFlorida32306-4301
Mallory Cannon, MS
[email protected]
850-644-2445

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By research site
The BRAINS Lab at Florida State University· Tallahassee, FL

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