Cannabis Use Disorder
Conditions
Keywords
Substance Use
Brief summary
This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.
Interventions
DRUGDronabinol
Oral dronabinol capsules (40 mg)
DRUGPlacebo
Matched placebo capsules
Sponsors
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide informed consent 2. Age 21-45 3. Meet DSM-5 criteria for CUD 4. Report cannabis use ≥4 days/week on average in the last 30 days at screening 5. Provide a THC-positive urine sample at screening 6. BMI between 18-30 kg/m2 7. Regular menstrual cycle (females only) 8. Willing to use non-hormonal birth control for the duration of study participation (females only)
Exclusion criteria
1. Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder 2. Urinalysis results indicative of recent drug use other than cannabis 3. Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes 4. Current treatment-seeking for CUD or other SUDs 5. Meet DSM-5 criteria for any current psychiatric disorder other than nicotine or caffeine use disorder, mild alcohol use disorder, CUD, or ADHD 6. Females who are pregnant, nursing, or planning to become pregnant 7. MRI contraindications (e.g., metallic implants, claustrophobia) 8. Significant history of nausea associated with the use of cannabis and/or THC 9. History of cardiac or seizure disorders 10. Allergy to sesame oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nucleus accumbens glutamate | 2 hours post-dose | Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy |
| Drug Effects Questionnaire (DEQ) - Like Drug Effect | 0-7 hours post-dose | Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation. |
| Sex differences in genetics | Day 1 | Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dorsal striatal glutamate | 2 hours post-dose | Concentrations of dorsal striatal glutamate measured via proton magnetic resonance spectroscopy |
| Drug Effects Questionnaire (DEQ) - Want More | 0-7 hours post-dose | Visual Analog Scale rating of subjective desire for more of the same drug included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation. |
| Drug Effects Questionnaire (DEQ) - High | 0-7 hours post-dose | Visual Analog Scale rating of subjective "high" included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation. |
Countries
United States
Contacts
CONTACTErin Martin, Ph.D.
Outcome results
None listed