Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 2

Conditions: Suicidal Ideation

Treatments: Drug: Nabilone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04807829

HSC-MS-20-1312

Details and patient eligibility

About

Suicide is a major crisis worldwide with rates projected to continue to increase. There is currently a dearth of novel pharmacologic treatment options for suicide available on the market. The endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. The aim of the study is to determine whether treatment with Nabilone is capable of reducing suicidal ideation in adults after 3 days.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to provide written informed consent
• Current suicidal ideation
• Columbia Suicide Severity Rating Scale (CSSRS) score of ≥ 4 and Scale for Suicide Ideation (SSI) first 5 items, score of ≥4
• Current major depressive episode as evidenced by MADRS score ≥ 20

Exclusion criteria

• Current diagnosis of a Diagnostic and Statistical Manual V (DSM-V) psychotic disorder, psychotic symptoms, or personality disorder.
• Recent (<72 hrs) use of illicit substances
• Comorbid substance use disorder diagnosis
• Urine drug screen (UDS) positive for tetrahydrocannabinol (THC)
• Pregnant or nursing women
• Unstable medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Nabilone

Experimental group

Description:

Patients in the treatment group will be administered oral Nabilone 2 mg once daily for 3 days in addition to treatment as usual according to current clinical guidelines and standard of care.

Treatment:

Drug: Nabilone

Placebo Comparator

Placebo Comparator group

Description:

Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual.

Treatment:

Drug: Placebo