- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594496
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
May 11, 2026 updated by: Mayo Clinic
This study evaluates the prevalence of cannabis withdrawal and the clinical manifestations of cannabis withdrawal syndrome in patients hospitalized for BMT or CAR-T therapy.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
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
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients admitted for BMT or CAR-T therapy
Description
Inclusion Criteria:
- All adult patients admitted for BMT or CAR-T therapy
Exclusion Criteria:
- Individuals unable to provide informed consent
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
Patients complete surveys and have their medical records reviewed on study.
|
Non-interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of cannabis withdrawal
Time Frame: Up to 1 year
|
Descriptive statistics will be utilized to summarize cannabis withdrawal prevalence.
|
Up to 1 year
|
|
Severity of withdrawal symptoms
Time Frame: Daily for first 4 days of hospitalization
|
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.
|
Daily for first 4 days of hospitalization
|
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.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Osama A. Abulseoud, MD, Mayo Clinic
- Principal Investigator: Sondra Schultz, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Actual)
February 18, 2026
Primary Completion (Estimated)
February 28, 2031
Study Completion (Estimated)
February 28, 2031
Study Registration Dates
First Submitted
May 11, 2026
First Submitted That Met QC Criteria
May 11, 2026
First Posted (Actual)
May 18, 2026
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 25-011419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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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