Studienlage · Detail
Gemischt
GRADE
Hoch
88 Zitate
Stichproben = 269 Pat.
Dauer12 Wochen
KontrolleVerzögerter Card-Erwerb nach 12 Wochen…
EndpunktCUD-Symptome / Insomnie /…
Verblindungeinfachblind
DesignRCT
Kernaussage
Medizinische Cannabis-Karte führte zu verbessertem Selbstbericht von Insomnie-Symptomen, aber zu höherer Inzidenz und Schweregrad von Cannabis-Use-Disorder und keiner signifikanten Verbesserung bei Schmerz, Angst oder depressiven Symptomen.
Zusammenfassung
n=269 Erwachsene mit Medical Cannabis Card (Massachusetts), 12-Monats-Follow-up zeigte keine signifikante Verbesserung affektiver Störungs-Symptome (Depression/Angst, gemessen mit PROMIS), moderate Verbesserungen bei Schmerz und Schlaf (p0.001), aber Affekt unverändert.
P
PopulationErwachsene (18–65 Jahre) mit chronischem Schmerz, Insomnie oder Angst-/Depressionssymptomen, n=186, Mittelwert 37,2 Jahre, 65,6% Frauen
I
InterventionSofortiger Erwerb einer Medical-Cannabis-Card mit freier Produktwahl aus Dispensary (n=105)
C
KontrolleVerzögerter Card-Erwerb nach 12 Wochen Wartezeit (n=81)
O
OutcomeHöhere CUD-Inzidenz in Sofort-Gruppe (17,1% vs. 8,6%, OR 2,88, p=0,02); Verbesserung der Insomnie-Symptome (MD -2,90, p<0,001); keine signifikante Änderung bei Schmerz oder Angst/Depression
Vertrauen in die Evidenz
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
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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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