Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04807829
• Other study ID #: HSC-MS-20-1312
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2021
• Est. completion date: April 2022

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Drug:
• Nabilone
Nabilone is a synthetic endocannabinoid and CB1 agonist.
• Placebo
Inactive placebo comparator

Locations

Country	Name	City	State
United States	Harris County Psychiatric Center (HCPC)	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	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.	baseline, day 3
Primary	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	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
Secondary	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
Secondary	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