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Post-Traumatic Stress Disorder Patients in the Minnesota Medical Cannabis Program: Experiences of Enrollees During the First Five Months JULY 2019

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Post-Traumatic Stress Disorder Patients in the Minnesota Medical Cannabis Program: Experiences of Enrollees During the First Five Months JULY 2019 Post-Traumatic Stress Disorder Patients in the Minnesota Medical Cannabis Program: Experiences of Enrollees During the First Five Months JULY 2019 POST- TRAUMATIC STRESS DISORDER PATIENTS IN THE MINNESOTA MEDICAL CANNABIS PROGRAM: EXPERIENCES OF ENROLLEES DURING THE FIRST FIVE MONTHS Post-Traumatic Stress Disorder Patients in the Minnesota Medical Cannabis Program: Experiences of Enrollees During the First Five Months Minnesota Department of Health Office of Medical Cannabis PO Box 64882 St. Paul, MN 55164-0882 651-201-5598 [email protected] Office of Medical Cannabis website (http://www.health.state.mn.us/people/cannabis/index.html) As requested by Minnesota Statute 3.197: This report cost approximately $47,000 to prepare, including staff time, printing and mailing expenses. To obtain this information in a different format, call: 651-201-5598. 2 POST- TRAUMATIC STRESS DISORDER PATIENTS IN THE MINNESOTA MEDICAL CANNABIS PROGRAM: EXPERIENCES OF ENROLLEES DURING THE FIRST FIVE MONTHS Contents Post-Traumatic Stress Disorder Patients in the Minnesota Medical Cannabis Program: Experiences of Enrollees During the First Five Months .................................................................. 1 Executive Summary ..................................................................................................................... 4 1. Patients and Caregivers Registered During the First Five Months of PTSD Enrollment ......... 8 Qualifying Condition ............................................................................................................... 8 Age and Gender ...................................................................................................................... 8 Race and Ethnicity ................................................................................................................... 9 Registered Caregivers and Parents/Legal Guardians .............................................................. 9 Geographic Distribution ........................................................................................................ 10 Primary Cause of PTSD .......................................................................................................... 11 2. Registered Healthcare Practitioners Certifying Early PTSD Patients .................................... 12 Healthcare Practitioners by Type.......................................................................................... 12 Certifying Physician Specialty ............................................................................................... 12 3. Medical Cannabis Use Patterns ............................................................................................ 14 4. Benefits ................................................................................................................................. 22 Summary ............................................................................................................................... 22 Benefits Reported on Patient Experience Survey and Health Care Practitioner Survey ...... 24 Benefits Reported on the Patient Self-Evaluation ................................................................ 47 5. Adverse Side Effects .............................................................................................................. 57 Summary ............................................................................................................................... 57 Adverse Side Effects on the Patient Self-Evaluation ............................................................ 58 Adverse Side Effects Reported on Surveys ........................................................................... 63 3 POST- TRAUMATIC STRESS DISORDER PATIENTS IN THE MINNESOTA MEDICAL CANNABIS PROGRAM: EXPERIENCES OF ENROLLEES DURING THE FIRST FIVE MONTHS Executive Summary In May of 2014 Minnesota became the 22nd state to create a medical cannabis program. Distribution of extracted cannabis products in liquid or oil form to qualified, enrolled patients began July 1, 2015. Post-traumatic stress disorder (PTSD) was added to the list of qualifying conditions for the program effective August 1, 2017. This report draws on data from enrollment, purchasing, symptom and side effect ratings at time of each purchase, and survey results to describe the experience of patients newly enrolled in the program for PTSD during the first five months it was a qualifying condition. Participation Between August 1 – December 31, 2017 a total of 751 patients enrolled in the program under the qualifying condition of PTSD. Note that patients who took advantage of pre-enrollment during the month of July were given an effective enrollment date of August 1 for this report. Most of the patients (65%) were between the ages of 25 and 49, 2% were <18, and 6% were ≥ 65 years. 53% were male. Distribution by race/ethnicity generally matched the state’s demographics for White (85%) and Black (6%); the Native American proportion (4%) was somewhat larger than in 2014 Census Bureau estimates for the state, and Asian (1%) somewhat smaller. Some patients were certified for one or more qualifying conditions in addition to PTSD; intractable pain was by far the most common (n=123; 16%). Most patients (68%) live within the Twin Cities metro region, based on first three digits of zip code; 7% live in the St. Cloud region, 6% in the Duluth region, 5% in the Willmar region, and 4% each in the Rochester and Mankato regions. The program allows patients to have one or more parents or non-parent caregivers who register with the program and then are allowed to transport and administer a patient’s medical cannabis. Only 1% of patients had a registered caregiver, 2% had a registered parent or legal guardian, and 3% had either a registered parent/legal guardian or a registered caregiver. By patient self-report the primary cause of PTSD for the majority of patients (71%) was non-military in nature, with 13% reporting military and 6% reporting both military and non-military. Seventy five patients (10%) indicated they preferred not to answer this question. A total of 107 health care practitioners registered with the program and certified for PTSD the 751 patients covered in this report; 72% were physicians, 20% were advanced practice registered nurses, and 8% were physician assistants. Most of the physicians (69%) were primary care physicians and 17% were psychiatrists. Medical Cannabis Use Patterns Each patient’s medical cannabis purchasing transactions during their first enrollment year were analyzed. A total of 15,538 products were purchased through 9,529 transactions. For analytic purposes, products were classified according to the ratio of delta-9-tetrahydrocannabinol (THC) to cannabidiol (CBD) as follows: • Very High THC:CBD (100:1 or higher) 4 POST- TRAUMATIC STRESS DISORDER PATIENTS IN THE MINNESOTA MEDICAL CANNABIS PROGRAM: EXPERIENCES OF ENROLLEES DURING THE FIRST FIVE MONTHS • High THC:CBD (>4:1 up to 99:1) • Balanced THC:CBD (1:1 Up to 4:1) • High CBD:THC (≥1:1 up to 99:1) • Very High CBD:THC (100:1 or higher) Products for inhalation (vaporized oil) accounted for 71% of products purchased, products for enteral administration (swallowed – includes capsules and oral solutions) accounted for 24%, oromucosal products accounted for 4%, and topical products 2%. When all routes of administration are combined, Very High THC:CBD products accounted for 55% of all product purchases, followed by Balanced products (27%), High THC:CBD products (9%), High CBD:THC products (9%), and Very High CBD:THC (<1%). Examining purchasing history across all patients is very complex for reasons that include experimentation with different products over time. As a first approach to assessing routine use of products, most frequently purchased products were examined for each patient. For 25% of patients, two or more products were purchased the same number of times. The product types that emerged as most frequently purchased were Very High THC:CBD vaporization oil (45%), balanced vaporization oil (7%), and balanced enteral preparations (6%). Benefits Information on patient benefits comes from the Patient Self-Evaluation (PSE) completed by patients prior to each medical cannabis purchase and from patient and health care practitioner surveys. At enrollment and in the patient surveys patients are asked to complete a questionnaire on PTSD symptoms called the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assess 20 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders – 5th edition) symptoms of PTSD. The PCL-5 was developed by the National Center for PTSD, part of the U. S. Department of Veteran Affairs. Among its purposes is monitoring symptom change before and after treatment. Results of analyses of the PSE and survey data (including PCL-5) indicate perceptions of a high degree of benefit for the majority of the patients. At enrollment, 96% of the 751 PTSD patients included in this report scored above 33 points, meeting the cut-point for provisional PTSD diagnosis. Comparing PCL-5 score at enrollment and at 3 months, for the 51% who responded to the survey 3 months after their first medical cannabis purchase, shows many experienced substantial benefit. Literature has shown that a clinically meaningful difference in PCL-5 scores measured at different times amounts to a difference of 10-20 points. Between 50% and 71% (depending on whether a reduction of 20 points or 10 points is used) of respondents
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