30 patients with chronic painful diabetic peripheral neuropathy were randomized to receive Sativex (tetrahydrocannabinol 27 mg/mL and cannabidiol 25 mg/mL) or placebo, titrated over 2 weeks and maintained for 10 weeks. The purpose of this study was to determine if Sativex treatment results in better Neuropathic Pain Scale (NPS), total pain score (TPS), McGill Pain and QOL, SF-36 Health Survey, and EuroQOL scores compared to placebo. Results indicate that Sativex did not significantly improve scores for any outcome measure compared to placebo, and 6 of 30 patients withdrew due to adverse effects. Patients with depression had significantly higher baseline pain and pain improvements compared to non-depressed patients, regardless of treatment.