Probing the Cannabinoid System in Individuals With a Family History of Psychosis

Yale University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Schizophrenia; Psychosis; THC; Cannabis Use; Marijuana

Treatments: Drug: Very Low Dose THC; Drug: Placebo; Drug: Low Dose THC

Study type: Interventional

Funder types: Other

Identifiers

NCT02102113

1310012948

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria FHN:

• Having a family member with psychosis
• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups

No Family History of Psychosis (FHN)

Other group

Description:

Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.

Treatment:

Drug: Low Dose THC

Drug: Placebo

Drug: Very Low Dose THC

Family History of Psychosis (FHP)

Experimental group

Description:

Individuals with a family member with a confirmed diagnosis of psychosis. They will receive the placebo, very low dose THC, and low dose THC interventions.

Treatment:

Drug: Low Dose THC

Drug: Placebo

Drug: Very Low Dose THC