For researchers SMILE: Study on Medical Marijuana and its long term effects

This study is titled "Real-time and long-term effects of medical marijuana on older adults: A prospective cohort study." The main goals of this project are to determine the effects of medical marijuana on pain; physical, emotional, and cognitive functioning; and quality of life in older adults. We also hope to examine which medical marijuana product characteristics are associated with improved outcomes and side effects.

Study Aims

Aim 1

Determine whether medical marijuana use leads to short-term changes in pain intensity level, physical and emotional functioning measured in real-time by smartphone-based ecological momentary assessment (subjective data) and the Fitbit device (objective data).

Aim 2

Determine whether medical marijuana use leads to longer-term changes over 12 months, measured by self-reported pain intensity, emotional and physical functioning, and health-related quality of life, and telomere length.

Aim 3

Among those initiating medical marijuana, examine which medical marijuana product characteristics (i.e., THC:CBD ratio, administration route, dose) predict more improvements in outcomes defined in Aims 1&2 or more side effects, and whether individual differences (e.g., sex, baseline pain phenotyping) moderate the relationship.

Supplementary Aim 1

Identify which gene modules are associated (over or under expression) with medical marijuana treatment and change in chronic musculoskeletal pain severity in older adults.

Supplementary Aim 2

Detect associations between changes in chronic pain severity and changes in allostatic load (individual health status) over 3 months in older adults who initiate and do not initiate medical marijuana (2a) and detect if the medical marijuana treatment is associated with an increase or decrease in chronic pain severity and allostatic load (2b).

Supplementary Aim 3

Develop a multi-level personalized medicine prediction model using causal machine learning to identify subpopulations of older adults with chronic musculoskeletal pain who are more likely to benefit from medical marijuana treatment.

Study Measures

Questionnaires

Demographics

Medical History

Height and Weight
Waist Measurement
Blood Pressure
Self-Reported Health History
Charlson Comorbidity Index
Medication Quantification Scale
World Health Organization - Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST)
Pharmalogical and Non-Pharmacological Treatments

Marijuana Use

Self-Reported Marijuana Use History
Comprehensive Marijuana Motives Questionnaire (CMMQ)
Medical Cannabis Expectancy Questionnaire (MCEQ)
Cannabis Use Disorder Identification Test-Revised (CUDIT-R)
Patient-Reported Medication Symptoms
Medical Marijuana Attitudes and Beliefs

Pain

Brief Pain Inventory (BPI)
Graded Chronic Pain Scale (GCPS)
Patient Global Impression of Change (PGIC)
Pain Frequency, Intensity, Time, and Total pain sites (FITT)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale -Version 4a
Self-Reported Non-Pharmacological Treatments

Emotion

PROMIS Depression Scale - Version 8a
PROMIS Anxiety Scale - Version 8a
PROMIS Global-10
Marlowe-Crowne Social Desirability Scale (MCSDS)
Positive and Negative General Affect Scale (PANAS)
PTSD
Pittsburgh Sleep Quality Index

Additional Assessments

Sensory Sensitivity Testing

Punctate Mechanical Stimuli
Pressure Pain Threshold

Neurocognitive Testing

NIH Toolbox Cognition Battery:

Picture Vocabulary Test
Flanker Inhibitory Control and Attention Test
List Sorting Working Memory Test
Dimensional Change Card Sort Test
Pattern Comparison Processing Speed Test
Picture Sequence Memory Test
Oral Reading Recognition Test

Biospecimens

Telomere Length Analysis
CBD and THC assay: 6a-OH-CBD, 7-OH-CBD, 11OH-THC, THC, CBD, CBC, CBD-gluc, THC-gluc, 7-CBD-COOH, THC-COOH, THC-COOH-Gluc, CBN, CBG, THCV, CBDV, THCV-COOH
Inflammasome Test
Neurodegeneration Biomarker Test
Gene Expression Test
Allostatic Load Test