Study register · detail
Mixed
GRADE
High
88 citations
Samplen = 269 Pat.
Duration12 weeks
ControlDelayed card acquisition after 12 weeks…
EndpointCUD symptoms / insomnia /…
Blindingeinfachblind
DesignRCT
Key finding
Medical cannabis card led to improved self-reported insomnia symptoms, but to higher incidence and severity of cannabis use disorder and no significant improvement in pain, anxiety or depressive symptoms.
Summary
n=269 adults with medical cannabis card (Massachusetts), 12-month follow-up showed no significant improvement in affective disorder symptoms (depression/anxiety, measured with PROMIS), moderate improvements in pain and sleep (p0.001), but affect unchanged.
P
PopulationAdults (18–65 years) with chronic pain, insomnia or anxiety/depression symptoms, n=186, mean 37,2 years, 65,6% women
I
InterventionImmediate acquisition of a Medical Cannabis Card with free choice of product from dispensary (n=105)
C
ControlDelayed card acquisition after 12 weeks waiting period (n=81)
O
OutcomeHigher CUD incidence in immediate group (17,1% vs. 8,6%, OR 2,88, p=0,02); improvement in insomnia symptoms (MD -2,90, p<0,001); no significant change in pain or anxiety/depression
Confidence in the evidence
High
The highest of four GRADE levels, the effect estimate is very reliable.
Quality profile
Sample size
★★★★★
Blinding
Single-blind
Effect size
Mixed
Citations / year
★★★★★
Authors
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Abstract
Importance: Despite the legalization and widespread use of cannabis products for a variety of medical concerns in the US, there is not yet a strong clinical literature to support such use. The risks and benefits of obtaining a medical Cannabis card for common clinical outcomes are largely unknown.
Objective: To evaluate the effect of obtaining a medical Cannabis card on target clinical and cannabis use disorder (CUD) symptoms in adults with a chief concern of chronic pain, insomnia, or anxiety or depressive symptoms.
Design, Setting, And Participants: This pragmatic, single-site, single-blind randomized clinical trial was conducted in the Greater Boston area from July 1, 2017, to July 31, 2020. Participants were adults aged 18 to 65 years with a chief concern of pain, insomnia, or anxiety or depressive symptoms. Participants were randomized 2:1 to either the immediate card acquisition group (n = 105) or the delayed card acquisition group (n = 81). Randomization was stratified by chief concern, age, and sex. The statistical analysis followed an evaluable population approach.
Interventions: The immediate card acquisition group was allowed to obtain a medical Cannabis card immediately after randomization. The delayed card acquisition group was asked to wait 12 weeks before obtaining a medical Cannabis card. All participants could choose cannabis products from a dispensary, the dose, and the frequency of use. Participants could continue their usual medical or psychiatric care.
Main Outcomes And Measures: Primary outcomes were changes in CUD symptoms, anxiety and depressive symptoms, pain severity, and insomnia symptoms during the trial. A logistic regression model was used to estimate the odds ratio (OR) for CUD diagnosis, and linear models were used for continuous outcomes to estimate the mean difference (MD) in symptom scores.
Results: A total of 186 participants (mean [SD] age 37.2 [14.4] years; 122 women [65.6%]) were randomized and included in the analyses. Compared with the delayed card acquisition group, the immediate card acquisition group had more CUD symptoms (MD, 0.28; 95% CI, 0.15-0.40; P < .001); fewer self-rated insomnia symptoms (MD, -2.90; 95% CI, -4.31 to -1.51; P < .001); and reported no significant changes in pain severity or anxiety or depressive symptoms. Participants in the immediate card acquisition group also had a higher incidence of CUD during the intervention (17.1% [n = 18] in the immediate card acquisition group vs 8.6% [n = 7] in the delayed card acquisition group; adjusted odds ratio, 2.88; 95% CI, 1.17-7.07; P = .02), particularly those with a chief concern of anxiety or depressive symptoms.
Conclusions And Relevance: This randomized clinical trial found that immediate acquisition of a medical Cannabis card led to a higher incidence and severity of CUD; resulted in no significant improvement in pain, anxiety, or depressive symptoms; and improved self-rating of insomnia symptoms. Further investigation of the benefits of medical Cannabis card ownership for insomnia and the risk of CUD are needed, particularly for individuals with anxiety or depressive symptoms. reported equity holdings in Pfizer outside the submitted work. Dr Evins reported receiving grants from Charles River Analytics and nonfinancial support from Pfizer as well as serving as chair of the data monitoring board of Karuna Pharmaceuticals outside the submitted work. No other disclosures were reported.
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