Health TrialsbyHealthPanel

Endocannabinoids in Reward

ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-45
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide informed consent

Age 21-45

Meet DSM-5 criteria for CUD

Report cannabis use ≥4 days/week on average in the last 30 days at screening

Disqualifiers

Meet DSM-5 criteria for any lifetime psychotic or bipolar disorder

Urinalysis results indicative of recent drug use other than cannabis

Current use of any psychotropic medication or over-the-counter supplements deemed by the investigator to have the potential to interfere with study outcomes

Current treatment-seeking for CUD or other SUDs

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dronabinol

    Drug

    Oral dronabinol capsules (40 mg)

  • Placebo

    Drug

    Matched placebo capsules

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: MalesOther 2 interventions
Group B: FemalesOther 2 interventions

Trial outcomes

Primary outcomes

1

Nucleus accumbens glutamate

Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy

Time frame
2 hours post-dose
2

Drug Effects Questionnaire (DEQ) - Like Drug Effect

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.

Time frame
0-7 hours post-dose
3

Sex differences in genetics

Blood-based DNA sample will be tested for genetic variants of interest involved in the endocannabinoid system

Time frame
Day 1

Secondary outcomes

1

Dorsal striatal glutamate

Concentrations of dorsal striatal glutamate measured via proton magnetic resonance spectroscopy

Time frame
2 hours post-dose
2

Drug Effects Questionnaire (DEQ) - Want More

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.

Time frame
0-7 hours post-dose
3

Drug Effects Questionnaire (DEQ) - High

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.

Time frame
0-7 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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