Prevalence and Clinical Manifestations of Cannabis Withdrawal in Hospitalized Patients With Hematological Malignancies Undergoing Bone Marrow Transplant (BMT) or Chimeric Antigen Receptor T-Cell (CAR-T) Therapy
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients admitted for BMT or CAR-T therapy
Exclusion Criteria:
- Individuals unable to provide informed consent
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Observational
Patients complete surveys and have their medical records reviewed on study.
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Non-interventional study
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of cannabis withdrawal
Time Frame: Up to 1 year
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Descriptive statistics will be utilized to summarize cannabis withdrawal prevalence.
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Up to 1 year
|
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Severity of withdrawal symptoms
Time Frame: Daily for first 4 days of hospitalization
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Assessed by the Cannabis Withdrawal Scale (CWS), a self-report instrument used measures the intensity of 19 cannabis withdrawal symptoms over the last 24 hours.
Each item is rated on a 10-point Likert scale where 0=not al all and 10=extremely.
Items are rated twice, first for intensity of symptom and then for negative impact on daily activity.
Withdrawal symptom scores range from 0 to 190, with higher scores reflecting greater intensity of withdrawal symptoms.
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Daily for first 4 days of hospitalization
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality Rate
Time Frame: Up to 1 year
|
Assessed for all-cause, in-hospital, and post-hospitalization mortality rates by review of the electronic medical record.
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Up to 1 year
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Osama A. Abulseoud, MD, Mayo Clinic
- Principal Investigator: Sondra Schultz, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 25-011419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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