Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Study Overview
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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.

Official Title
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A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Drug: Nabilone
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nabilone<br>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. | Drug: Nabilone<br>* Nabilone is a synthetic endocannabinoid and CB1 agonist.<br>* Other names: Cesamet;|
| Placebo Comparator: Placebo Comparator<br>Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual. | Drug: Placebo<br>* Inactive placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Suicidal Ideation and Behavior as assessed by an abbreviated version of the Columbia-Suicide Severity Rating Scale (CSSRS) | For the abbreviated, six-question version of the CSSRS, total scores range from 0 to 6 with a higher score indicating greater suicidal ideation and behavior. | baseline, day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a ten item instrument, with each of the ten items rated on a scale of 0 to 6, giving a total score range of 0 to 60. A higher score indicates greater depression. | baseline, day 3 | 
| Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI) | The SSI is a nineteen item measure of current suicidal ideation and intention, with each item rated on a scale of 0 to 2, giving a total score range of 0 to 38. A higher score indicates greater suicidal ideation and intention. | baseline, day 3 | 
| Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) | The GAD-7 is a seven item instrument, with each of the 7 items is scored from 0 to 3, giving a total score range of 0 to 21. A higher score indicates greater anxiety. | baseline, day 3 |