ArticlePilot and feasibility studies2025
A pilot study of dronabinol for the treatment of pain in sickle cell disease.
Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease
Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
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6 authors.
Funding
Abstract
backgroundMany adults living with sickle cell disease (SCD) suffer from chronic pain, turning to cannabis for relief. However, there are few studies that examine the efficacy of cannabis in treating pain associated with SCD. Prior to an efficacy study, a feasibility study is necessary to evaluate if such a study would be acceptable to patients, including those who use cannabis; if participants would be able to abstain from other cannabinoid-containing substances during the study; if masking would be feasible; and if dronabinol would prove safe.
methodsWe approached outpatients with SCD of any genotype at healthy baseline and asked about interest in such a study. If eligible enrolled participants received dronabinol or placebo for two, 2-week periods. Feasibility outcomes were acceptability (patient interest and enrollment rates), protocol adherence (completion of stud procedures), cannabinoid avoidance, and masking effectiveness. Patient-reported outcomes (PRO), laboratory markers of inflammation, and urine tests for the presence of cannabinoids were collected after each exposure period.
resultsA total of 27 patients were approached; 23 (85%) were interested, 13 (48%) signed consents, and 6 (22%) were enrolled so the study was determined to be acceptable. Patients who used unregulated cannabis and medical cannabis also found the study acceptable. All enrolled participants successfully completed all study procedures. Urine testing revealed no cannabinoid use except for study drug, so the study was determined to be feasible. While 4 out of 6 (67%) participants correctly identified their exposure assignment after the first study period, all 6 (100%) identified the exposure assignment after the second treatment period, so masking after the second period was not feasible. No serious adverse events were attributed to dronabinol.
conclusionIn conclusion, a controlled study of dronabinol is acceptable, feasible, and safe to participants. However, a crossover design compromises participant masking. A larger, longer, controlled efficacy study without the crossover component is now being performed (NCT05519111). Trial registration NCT03978156. Date of registration: 07/26/2019.
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