Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04807829

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation	Drug: Nabilone Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Nabilone Nabilone is a synthetic endocannabinoid and CB1 agonist. Other Names: Cesamet
Placebo Comparator: Placebo Comparator Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual.	Drug: Placebo Inactive placebo comparator

Arm

Intervention/Treatment

Experimental: 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.

Drug: Nabilone

Nabilone is a synthetic endocannabinoid and CB1 agonist.

Other Names:

Cesamet

Placebo Comparator: Placebo Comparator

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

Drug: Placebo

Inactive placebo comparator

Outcome Measures

Primary Outcome Measures

Change in Suicidal Ideation and Behavior as assessed by an abbreviated version of the Columbia-Suicide Severity Rating Scale (CSSRS) [baseline, day 3]
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.

Secondary Outcome Measures

Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) [baseline, day 3]
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.
Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI) [baseline, day 3]
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.
Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) [baseline, day 3]
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.

Other Outcome Measures

Biomarkers [baseline, day 3]
To determine whether treatment with Nabilone would lead to changes in the level of serum biomarkers and inflammatory cytokines; and their association with its antisuicidal and antidepressant effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harris County Psychiatric Center (HCPC)	Houston	Texas	United States	77021

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc, UTHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rodrigo Machado-Vieira, MD, PhD, MSc, Professor of Psychiatry, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04807829

Other Study ID Numbers:

HSC-MS-20-1312

First Posted:

Mar 19, 2021

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Suicidal Ideation

Nabilone

Study Results

No Results Posted as of Sep 22, 2021