Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nabilone

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.

Group Type EXPERIMENTAL

Nabilone

Intervention Type DRUG

Nabilone is a synthetic endocannabinoid and CB1 agonist.

Placebo Comparator

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive placebo comparator

Interventions

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Nabilone

Nabilone is a synthetic endocannabinoid and CB1 agonist.

Intervention Type DRUG

Placebo

Inactive placebo comparator

Intervention Type DRUG

Other Intervention Names

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Cesamet

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No