Is Medicinal Cannabis an Effective Treatment for Tourette Syndrome in Adolescents? A Pilot Study
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study
of 10 participants comparing medicinal cannabis (THC:CBD 10:15 oil) with placebo in reducing
tics in adolescents aged 12 - 18 years with severe Tourette Syndrome (TS).
The primary objective of this pilot study is to evaluate all elements of the study design
(recruitment strategy, study duration, study procedures, study medication tolerance and
outcome measures) to assess if they are acceptable and feasible for the conduct of a
full-scale randomized controlled trial of THC:CBD 10:15 oil to reduce tic severity in
adolescents with TS.
The secondary objective of this study is to collect preliminary data on the safety of oral
THC:CBD 10:15 oil in adolescents aged 12 to 18 years with TS.
As an exploratory aim data from clinician- and parent-rated measures will be compared across
the phases to explore for a signal of efficacy on primary (tic reduction) and secondary
(premonitory urges, obsessive compulsive behaviors, Attention Deficit Hyperactivity Disorder
[ADHD] symptoms) outcome measures.