Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

Phase 2

Withdrawn

• Conditions: Suicidal Ideation
• Interventions: Drug: Placebo; Drug: Nabilone

• Registration Number: NCT04807829
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Study Start: 2021-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Harris County Psychiatric Center (HCPC); 🇺🇸 Houston, Texas, United States