Cannabis Use, Marijuana, Psychosis, Schizophrenia, THC
Conditions
Brief summary
The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.
Interventions
DRUGPlacebo
placebo
DRUGVery Low Dose THC
Subjects will receive 0.010mg/kg.
DRUGLow Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
FHP: * Exposure to cannabis at least once in their lifetime * Medically and psychiatrically healthy based on screening * Having one relative with a confirmed psychotic disorder
Exclusion criteria
FHP: * Current or lifetime major DSM-IV Axis I disorder * Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness * Major or unstable medical illness that might impact safety of the subject in the study * Cannabis naive * IQ less than 85 * Less than a high school diploma or its educational equivalent * Pregnancy or lactation * Major current or recent (\<6 weeks) psychosocial stressors. Inclusion Criteria FHN : * Exposure to cannabis at least once in their lifetime * Medically and psychiatrically healthy based on screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptom Scale for Schizophrenia (PANSS) | -30 min from administration of THC | Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered Dissociative Symptoms Scale (CADSS) | -30 min, +15 min, +80 min, +150 min, +240 min | Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-report items and 8 clinician-rated items (0=not at all, 4=extremely). The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment. |
| Visual Analog Scale (VAS) | -30 min, +15 min, +80 min, +150 min, +240 min | Feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states (high, anxious, calm and relaxed, and tired) associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11 mm line (0=not at all, 100=extremely). These data will be captured to validate that the experiment is relevant to cannabis effects. |
| Hopkins Verbal Learning Test (HVLT) | +50 min | The HVLT is a 12 word list that is semantically organized. The task consists of 5 trials, an interference list, and free delayed recall and recognition. A different version of the AVLT will be administered on each test day and counterbalanced across subjects. |
| Psychotomimetic States Inventory (PSI) | -30 min, +240 min | The PSI is a measure of drug induced psychotomimetic states. This self-report scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC. |
Countries
United States
Outcome results
None listed