PMID- 36040329 OWN - NLM STAT- MEDLINE DCOM- 20231026 LR - 20231103 IS - 2378-8763 (Electronic) IS - 2378-8763 (Linking) VI - 8 IP - 5 DP - 2023 Oct TI - A Double-Blind, Randomized, Controlled Crossover Trial of Cannabis in Adults with Tourette Syndrome. PG - 835-845 LID - 10.1089/can.2022.0091 [doi] AB - Background: The number of effective evidence-based treatment options for patients with Tourette syndrome (TS) is limited. Emerging evidence shows cannabinoids as promising for the treatment of tics. Objectives: To compare the efficacy and tolerability of single doses of three vaporized medical cannabis products and placebo in reducing tics in adults with TS. Methods: In a randomized, double-blind, crossover design, each participant received a vaporized single 0.25 g dose of Delta(9)-tetrahydrocannabinol (THC) 10%, THC/cannabidiol (CBD) 9%/9%, CBD 13%, and placebo at 2-week intervals. Our primary outcome was the Modified Rush Video-Based Tic Rating Scale (MRVTRS), taken at baseline and at 0.5, 1, 2, 3, and 5 h after dose administration. Secondary measures included the Premonitory Urge for Tics Scale (PUTS), Subjective Units of Distress Scale (SUDS), and Clinical Global Impression-Improvement (CGI-I). Correlations between outcomes and cannabinoid plasma levels were calculated. Tolerability measures included open-ended and specific questions about adverse events (AEs). Results: Twelve adult patients with TS were randomized, with nine completing the study. There was no statistically significant effect of product on the MRVTRS. However, there was a significant effect of THC 10%, and to a lesser extent THC/CBD 9%9%, versus placebo on the PUTS, SUDS, and CGI-I. As well, there were significant correlations between plasma levels of THC and its metabolites, but not CBD, with MRVTRS, PUTS, and SUDS measures. There were more AEs from all cannabis products relative to placebo, and more AEs from THC 10% versus other cannabis products, particularly cognitive and psychomotor effects. Most participants correctly identified whether they had received cannabis or placebo. Conclusions: In this pilot randomized controlled trial of cannabis for tics in TS, there was no statistically significant difference on the MRVTRS for any of the cannabis products, although the THC 10% product was significantly better than placebo on the secondary outcome measures. Also, THC and metabolite plasma levels correlated with improvement on all measures. The THC 10% product resulted in the most AEs. ClinicalTrials.gov ID: NCT03247244. FAU - Abi-Jaoude, Elia AU - Abi-Jaoude E AUID- ORCID: 0000-0002-2448-9758 AD - Department of Psychiatry, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. AD - Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada. FAU - Bhikram, Tracy AU - Bhikram T AD - Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada. FAU - Parveen, Ferdous AU - Parveen F AD - Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada. FAU - Levenbach, Jody AU - Levenbach J AD - Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada. FAU - Lafreniere-Roula, Myriam AU - Lafreniere-Roula M AD - Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada. FAU - Sandor, Paul AU - Sandor P AD - Department of Psychiatry, University Health Network, University of Toronto, Toronto, Ontario, Canada. AD - Youthdale Treatment Centers, Toronto, Ontario, Canada. LA - eng SI - ClinicalTrials.gov/NCT03247244 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20220830 PL - United States TA - Cannabis Cannabinoid Res JT - Cannabis and cannabinoid research JID - 101684827 RN - 19GBJ60SN5 (Cannabidiol) RN - 0 (Cannabinoid Receptor Agonists) RN - 7J8897W37S (Dronabinol) RN - 0 (Hallucinogens) SB - IM MH - Adult MH - Humans MH - Cannabidiol/adverse effects MH - Cannabinoid Receptor Agonists/adverse effects MH - *Cannabis/adverse effects MH - Cross-Over Studies MH - Dronabinol/adverse effects MH - Hallucinogens MH - *Tics/drug therapy MH - *Tourette Syndrome/drug therapy OTO - NOTNLM OT - Tourette syndrome OT - cannabidiol OT - cannabis OT - randomized controlled trial OT - tics OT - Delta9-tetrahydrocannabinol EDAT- 2022/08/31 06:00 MHDA- 2023/10/23 12:43 CRDT- 2022/08/30 10:06 PHST- 2023/10/23 12:43 [medline] PHST- 2022/08/31 06:00 [pubmed] PHST- 2022/08/30 10:06 [entrez] AID - 10.1089/can.2022.0091 [doi] PST - ppublish SO - Cannabis Cannabinoid Res. 2023 Oct;8(5):835-845. doi: 10.1089/can.2022.0091. Epub 2022 Aug 30.