Suicidal IdeationPhase 2NCT04807829
Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
A Phase 2 study testing Nabilone in people with Suicidal Ideation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Nabilone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2021to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harris County Psychiatric Center (HCPC)
Houston, Texas, 77021
About this study
Official title: 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.
- Conditions
- Suicidal Ideation
- Being tested
- Nabilone, Placebo
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NabiloneDrug
Also called Cesamet
Nabilone is a synthetic endocannabinoid and CB1 agonist.
PlaceboDrug
Inactive placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nabilone |
| Placebo Comparator | Placebo comparator | Patients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, day 3
Secondary outcomes (3)
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.
Measured: baseline, day 3
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.
Measured: baseline, day 3
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.
Measured: baseline, day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Machado-Vieira, MD, PhD, MSc, The University of Texas Health Science Center, Houston
- Investigators
- Rodrigo Machado-Vieira, MD, PhD, MSc, Principal investigator, UTHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807829
- Sponsor's protocol ID
- HSC-MS-20-1312
- Status last verified
- Sep 2021
- First submitted
- 17 Mar 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Trial With the Adjunctive CB1 Agonist Nabilone in Inpatients With Active Suicidal Ideation
- ClinicalTrials.gov ID
- NCT04807829
- Acronym / sponsor ID
- HSC-MS-20-1312
- Conditions
- Suicidal Ideation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to drug unavailability. The drug is unavailable because production was discontinued in the US.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nabilone | Experimental | Drug: NabilonePatients 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. |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPatients in the Placebo Comparator group will receive placebo once daily for 3 days plus treatment as usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NabiloneAlso: CesametNabilone is a synthetic endocannabinoid and CB1 agonist. | Drug | Nabilone |
| PlaceboInactive placebo comparator | Drug | Placebo Comparator |
Primary outcome
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.
3 secondary outcomes
Change in Depression as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: baseline, day 3
Change in Suicidal Ideation as assessed by the Scale for Suicide Ideation (SSI)
Time frame: baseline, day 3
Change in Anxiety as assessed by the General Anxiety Disorder-7 (GAD-7)
Time frame: baseline, day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Related trials for Suicidal Ideation
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department.
Suicidal Ideas, Suicidal Ideation
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Depressive Disorder, Major
Active, not recruiting
Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention
Suicide and Depression, Adolescent Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Machado-Vieira, MD, PhD, MSc principal investigator
UTHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nabilone in people with Suicidal Ideation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.