Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Primary Purpose
Suicidal Ideation
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nabilone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
Eligibility Criteria
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
Sites / Locations
- Harris County Psychiatric Center (HCPC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nabilone
Placebo Comparator
Arm Description
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.
Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04807829
First Posted
March 17, 2021
Last Updated
September 15, 2021
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT04807829
Brief Title
Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Official Title
A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nabilone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual.
Intervention Type
Drug
Intervention Name(s)
Nabilone
Other Intervention Name(s)
Cesamet
Intervention Description
Nabilone is a synthetic endocannabinoid and CB1 agonist.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive placebo comparator
Primary Outcome Measure Information:
Title
Change in Suicidal Ideation and Behavior as assessed by an abbreviated version of the Columbia-Suicide Severity Rating Scale (CSSRS)
Description
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.
Time Frame
baseline, day 3
Secondary Outcome Measure Information:
Title
Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
baseline, day 3
Title
Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI)
Description
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.
Time Frame
baseline, day 3
Title
Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
baseline, day 3
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
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.
Time Frame
baseline, day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Machado-Vieira, MD, PhD, MSc
Organizational Affiliation
UTHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harris County Psychiatric Center (HCPC)
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
12. IPD Sharing Statement
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Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
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