2. Materials and Methods
pain, sleep disturbance, anxiety, RadicleRecruits
This study, RadicleRecruits who consented to participate and completed intake were randomized to one of three study arms (see below for details on randomization): Sleep A, Sleep B, or placebo (Participants were sent a 4-week supply of their study product in the mail, along with the product insert, detailing instructions for study participation. All study products were provided by the partnering manufacturer and analyzed at an independent laboratory to ensure active ingredient identification, safety, and potency. Participants were instructed to take one softgel 30 min before bedtime, and informed that they could escalate to a maximum of four softgels per day as needed throughout the study duration. The number of softgels consumed were recorded. Participants were directed to wait 5 days before increasing the number of softgels taken. The study product formulations are proprietary to the manufacturer, but both Sleep A and B formulations contained the same amount of CBD, CBN, and L-theanine; Sleep A formula contained lower amounts of THC (0.35 mg) and higher amounts of GABA (150 mg), hops oil (75 mg), and valerian oil (75 mg) relative to the Sleep B formula (0.85 mg THC, 125 mg GABA, 20 mg hops oil, 20 mg valerian oil). The study was double-blind; neither the participants nor those who collected and analyzed the data were aware of the product participants received until the conclusion of the study. The study was conducted from October 2022 to December 2022.For 5 weeks following the study initiation and baseline (4 weeks taking the study product and 1 week after finishing the study product), participants were asked to complete online surveys, which they accessed via unique hyperlinks sent at scheduled times via email or text. During the baseline week, participants completed health outcome assessments of their sleep, feelings of anxiety, stress, pain, and overall well-being, using validated, patient-reported outcome measures (Throughout the study duration, participants received a health survey asking them to report their study product usage for the week and health outcome assessments for their sleep disturbance, feelings of anxiety, stress, pain, and overall well-being from the past week using the same validated health measures used at baseline. In every study survey, following receipt of their product, participants were also prompted to report any side effects and were encouraged to contact the research team directly if they experienced side effects at any point.The Sterling Independent Review Board (SIRB) approved the study [10147]. The master protocol Radicle Rest