Life's End Benefits of Cannabidiol and Tetrahydrocannabinol (LiBBY)
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ClinicalTrials.gov Identifier: NCT05644262 |
Recruitment Status :
Recruiting
First Posted : December 9, 2022
Last Update Posted : March 27, 2024
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | November 16, 2022 | |||||||||
First Posted Date ICMJE | December 9, 2022 | |||||||||
Last Update Posted Date | March 27, 2024 | |||||||||
Actual Study Start Date ICMJE | December 18, 2023 | |||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Change from Baseline in agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 2 weeks [ Time Frame: Baseline, Day 7 and Day 14 ] The Cohen-Mansfield Agitation Inventory (CMAI) assesses the average frequency of manifestations of agitated behaviors in elderly persons over a 1-week period. The CMAI is a questionnaire consisting of 29 agitated behaviors, each rated on a 7-point frequency scale. In addition to the frequency of each behavior, informants/caregivers will be asked to use a 5-point scale to rate the disruptiveness of each behavior. For this study, the CMAI will target behaviors observed by knowledgeable informants/informed caregivers. Expanded descriptions of the behaviors will be provided to the informant/caregiver to be used as a reference during the interview.
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Life's End Benefits of Cannabidiol and Tetrahydrocannabinol | |||||||||
Official Title ICMJE | Life's End Benefits of CannaBidiol and TetrahYdrocannabinol (LiBBY) | |||||||||
Brief Summary | This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 24 week optional open-label extension will be offered to participants who complete the double-period. |
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Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 2 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Recruiting | |||||||||
Estimated Enrollment ICMJE |
150 | |||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||
Estimated Study Completion Date ICMJE | December 2025 | |||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT05644262 | |||||||||
Other Study ID Numbers ICMJE | ATRI-007 5R01AG068324-03 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Paul Aisen, University of Southern California | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | University of Southern California | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Southern California | |||||||||
Verification Date | March 2024 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |