Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation

September 15, 2021 updated by: Rodrigo Machado-Vieira, MD, PhD, MSc, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77021
        • Harris County Psychiatric Center (HCPC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)
Time Frame: 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.
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)
Time Frame: 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.
baseline, day 3
Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI)
Time Frame: 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.
baseline, day 3
Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7)
Time Frame: 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.
baseline, day 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers
Time Frame: 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.
baseline, day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-20-1312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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