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reference
Tervo-Clemmens B, Schmitt W, Wheeler G, et al. Cannabis use and sleep quality in daily life: an electronic diary study of adults starting cannabis use for health reasons.Addicted to drugs and alcohol. 2023;243:109760.
Key to take away
The daily effects of cannabis can be monitored using a patient-completed survey. Sleep is positively affected by cannabis, but mood disorders (e.g. anxiety, depression) and pain are not.
design
Pragmatic, single-site, single-site randomized treatment clinical trial
Participant
This study looked at 1,224 people in the Boston area who applied for a cannabis health card due to existing health conditions. Of these, 269 people enrolled and 186 completed at least one baseline and one postbaseline visit. Two participants in the treatment group experienced delays in receiving their medical cannabis card. They reported cannabis use before receiving the card and were therefore excluded. Three participants who did not complete at least 10% of the daily record were also excluded. Thus, the final sample comprised 181 subjects.
All participants had already applied for a cannabis medical card for medical reasons.
The medical cannabis card treatment group consisted of 102 adults (68 women, 33 men, 1 non-binary), and the waitlist control group consisted of 79 adults (50 women, 29 men, 0 non-binary). Participants were largely from a “non-Hispanic or Latino, white” ethnic/racial background. The average training period in both groups was 16 years. Cannabis consumption per day was between 0 and 2.5 times in both groups.
Inclusion criteria
Adults ages 18 to 65 seeking a medical cannabis card for insomnia, pain, anxiety and/or depression in the Greater Boston area.
Exclusion criteria
Chronic use disorder, cancer, psychosis, current substance use disorder (except mild to moderate alcohol use disorder and nicotine use disorder), and current cannabis use.
intervention
Participants were randomly selected to receive a medical cannabis card (MCC) or assigned to the waitlist control group (WLC), where they agreed to wait 12 weeks before receiving the card. Participants were stratified by gender, age, and the specific problem, which included mood disorders (44 in MCC, 37 in WLC), insomnia (22 in MCC, 19 in WLC), and pain (36 in MCC, 0 in WLC). The investigators followed both groups for a period of 90 days. The study took place from June 2017 to August 2020.
Participants were asked to complete daily online self-reports of cannabis use and symptoms (sleep, mood, and pain).
Subjects were paid $2.00 per day they completed the survey and $6.00 for completing all seven days per week, or up to $20.00 per week. Investigators did not provide information on the number of subjects paid or the amount paid.
Evaluated study parameters
Athens Insomnia Scale, Hospital Anxiety and Depression Scale, Brief Pain Inventory for worst pain, and daily self-reports for the past 24 hours. Urinalysis for cannabinoids and their primary metabolites as well as 15 other cannabinoids in urine using high-performance liquid chromatography with tandem mass spectrometry.
Primary outcome
The primary outcome was to determine the feasibility of a self-reported longitudinal assessment of cannabis use for health conditions. The secondary outcome was to assess the association between cannabis use and sleep, mood and pain symptoms over both short periods (same day) and long periods (90 days).
Key findings
The average daily completion of the survey was 72 days out of 90, for a mean of 66.21 days. The total number of daily surveys completed did not differ significantly between MCC and WLC. A positive correlation with daily completion was found between age (P=0.001) and years of training (P=0.017). The treatment group reported using cannabis about half of the days in their daily diary.
Cannabis consumption increased significantly compared to the start of treatment (P=0.007), but not in waiting list compartments (P=0.071). The cannabis metabolites in urine varied widely, so researchers only noted qualitative results, whether present or not.
Sleep quality in the MCC group was better after days of cannabis use than after days without use (P<0.001), suggesting that long-term improvements are due to consumption rather than the lasting effects of a single dose of cannabis. The effect of cannabis on sleep quality varied significantly (P=0.026), depending on the problem at hand. Results for self-reported sleep problems were positive (P=0.007), as well as the results for mood (P<0.001), but not with pain (P=0.623). There was no association between urinalysis and depressive symptoms or pain symptoms as the primary problem. Sleep patterns suggested that long-term improvements were associated with increases in frequency of cannabis use, but information on amounts was lacking.
transparency
The clinical trial identifier is: NCT03224468. This study was designed and conducted by a group focused on the treatment of substance use disorders and was funded by the National Institute on Drug Abuse (NIH award number R01DA042043). The authors wrote: "The funder had no role in the design and conduct of the study..." The authors' disclosures state: "AEE served as a consultant to Charles River Analytics (NIDA SBIR grant) and Karuna Pharmaceuticals (Chair of the Data Monitoring Board)." Other authors disclosed investments in various pharmaceutical companies.
Effects on practice
In a separate paper, these researchers found that some medical cannabis users developed cannabis use disorder (CUD), based on grade 5ThEdition of theDiagnostic and Statistical Manual of Mental Disorders. These results ranged from 3% to 10% at 2 weeks, 5% to 13% at 4 weeks, and 3% to 19% at 12 weeks, with the incidence of CUD being most common in those seeking cannabis for depression and anxiety but significantly less common in those using cannabis for pain or insomnia.1
In the above study, urine was provided from 97 subjects (67.01% female), with 256 samples meeting the analysis criteria. The test subjects were light users, less than monthly at the start of the study. After treatment, 39% to 47% used cannabis 3 to 4 days per week; 15 to 20% used it 5 to 6 days per week; and 29% to 54% used cannabis daily. Cannabis metabolites were found in 220 samples (85.9%). In cannabidiol (CBD)-dominant and CBD-tetrahydrocannabinol (THC) products (which contained equal amounts of CBD and THC), no CBD was found in 30.3% and 37% of urine samples, respectively. THC was present in 78.8% of samples from subjects who used a CBD-dominant product. No THC metabolites were found in THC-dominant or THC-CBD products in 10.9% and 35.2%, respectively.2
Vaping was the most common method of administration among subjects, but 19.7% of urine samples returned no cannabis metabolites. CBD was most often found in the urine of participants who took it orally or smoked, and THC was most often found in the urine of participants who took it orally or smoked. E-cigarette users produced little or no cannabis metabolites. These results echo those from California and Washington, where more than half of cannabis products appeared to be mislabeled.3
The urine results from this study are concerning.
Comparison of this work with others from this group suggests that there may be benefit for some subjects with anxiety, but not for depressed subjects. However, most of their reports combine data from anxiety and depression with mood disorders or depressive disorders, and these results were not significantly beneficial. This study was designed and conducted by a group focused on treating substance use disorders and was funded by the National Institute on Drug Abuse.
This study highlights the risk of patients obtaining cannabis or a medical license for cannabis and consuming it with little or no medical supervision. In Canada, CBD is only available with a prescription from a doctor or nurse practitioner under the supervision of a prescriber. In my clinical experience, these patients receive care and counseling or are unable to renew their medical cannabis license. In Canada, THC is available over the counter and individuals can access and use these products and quantities as they wish as long as they are of legal age.
The urine results from this study are concerning. Did the products these subjects received medically actually contain no cannabis, or were the testing methods used by this research group flawed? The EMIT-dau (Enzyme Multiplied Immunoassay Technique for Drug Abuse) screening test has a sensitivity limit of 20 ng/ml urine and a 100% true negative result in unadulterated samples with false positives of 3%. Gas chromatography-mass spectrometry provides nearly 100 percent accuracy in detecting cannabis.4The Drug Abuse Screening Test (DAST) is a two-part urine test for THC that detects THC at 50 ng/mL or greater. THC can last anywhere from 10 days to 4 weeks depending on the intensity of consumption.5Dronabinol, cannabidiol (CBD), and plant sources will also provide positive results.5Saliva tests can detect exposure 24 to 72 hours after use; Hair tests can detect up to 90 days after use, while blood tests only detect after 3 to 4 hours. Urine levels are highest 0.6 to 7.4 hours after smoking.5
The aim of this study was to assess whether cannabis users would correctly complete an online survey daily using their own personal devices. This process was successful in this process. A secondary outcome was the effect of medicinal cannabis on insomnia, pain, anxiety and depression; only the insomnia improved. Serious weaknesses of this study included the type and strength of cannabis subjects received (never assessed or tested), mode of cannabis administration (oral, smoked, vaporized, but not controlled), clinical condition (never assessed), lack of monitoring to achieve or assess clinical efficacy, and poor detection of cannabis metabolites in urine of these subjects, which prevented a correlation of reported consumption with urinary metabolite levels. Their publications focus on the development of cannabis use disorder in depressed (and possibly anxious) individuals and conclude that no data support the clinical use of cannabis. In fact, if you read the article cover to cover, anxiety was grouped under depression without any explanation as to why or whether they are even equivalent medical conditions.
My review of the literature found that THC can reduce anxiety at low doses and increase anxiety at high doses, while CBD reduced anxiety at all doses.6Some people are at risk of abuse.6A Canadian study found that anxiety decreased over 1 to 3 months and after 2 years; The change in depression was smaller.7The researchers appear to have an anti-addiction bias, and this appears to have crept into the interpretation of their results. The lack of control over the procurement and administration of the cannabis likely contributed to the lack of association with urine testing.
Summary
Patients who receive a cannabis medical card will be able to track their daily consumption on their personal devices over a 12-week period. Cannabis consumption can result in significant sleep improvements, but the formulation of the cannabis in the study was unknown, the cannabis dosage was unknown, and the amount consumed did not correlate with urine tests in this study. Increasing cannabis use may or may not lead to cannabis use disorder. This has not been objectively verified in this study or in the authors' other work, but was a conclusion in the primary publication of this study.1