Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

NCT04807829 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HSC-MS-20-1312
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

  baseline, day 3

• Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI)

  baseline, day 3

• Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7)

  baseline, day 3

Other Outcomes (1)

• Biomarkers

  baseline, day 3

Study Arms (2)

Nabilone

EXPERIMENTAL

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

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Nabilone DRUG

Nabilone is a synthetic endocannabinoid and CB1 agonist.

Also known as: Cesamet

Nabilone

Placebo DRUG

Inactive placebo comparator

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Harris County Psychiatric Center (HCPC)

Houston, Texas, 77021, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Interventions

nabilone

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Rodrigo Machado-Vieira, MD, PhD, MSc

  UTHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

US (1)