Guanfacine extended-release Randomised controlled trial for Adolescents
with Cannabis usE: Protocol for the GRACE trial
Abstract
Aim: Cannabis use disorder (CUD) typically onsets before age 22
and accounts for the majority of substance use treatment presentations
by Australian youth. There are no established pharmacotherapies for CUD.
Guanfacine extended-release (XR) is an alpha 2a adrenergic receptor
agonist that is approved for attention deficit hyperactivity disorder in
children and adolescents. Immediate-release guanfacine alleviates some
cannabis withdrawal symptoms in adults. The XR formulation can be taken
once daily, is well-characterised in children and adolescents, and
reduces impulsivity in those with ADHD. The GRACE study – embedded
within youth substance use treatment services in Victoria, Australia –
will assess whether guanfacine XR added to treatment as usual (TAU)
reduces the frequency of cannabis use following monitored abstinence in
youth with CUD. Methods: GRACE is a pragmatic Phase 2b,
double-blind, parallel-group superiority randomised controlled trial of
guanfacine XR for youth aged 12-25 years seeking treatment for CUD
(mild-severe). Participants (N=100) are randomly assigned in a 1:1 ratio
to receive guanfacine XR (target dose 4 mg/day) or placebo plus TAU,
including residential admission for supervised withdrawal for up to 14
days. The primary endpoint is efficacy, indexed by change from baseline
in frequency of cannabis use (days/week) during 4-weeks in the community
following discharge from residential withdrawal, measured weekly with
the Timeline Follow Back. Results. GRACE commenced recruitment
in August 2023; data collection is ongoing. Conclusions. The
GRACE trial will investigate the efficacy of guanfacine XR – a
promising candidate for CUD – in young people presenting for CUD
treatment.