Investigators: Associate Professor Gillinder Bedi (Orygen) and Mr Andrew Bruun (YSAS)
The GRACE study is a partnership between Orygen and YSAS (Youth Support and Advocacy Service). It has been funded by the Victorian government.
The GRACE study aims to explore the effects of a medicine called extended-release guanfacine (guanfacine XR), which we think may help young people with cannabis use when combined with treatment-as-usual.
There are no effective medications for people with cannabis use. Although counselling is effective for many, combining psychological treatment with medication could help people with cannabis use, and improve outcomes for young people. Therefore, there is a need to identify medications that might help young people with cannabis use.
We hope that the results of this study will help us to provide the best possible care in the future for young people wanting help with cannabis use.
WHAT DOES THE STUDY INVOLVE?
Participation in this study takes approximately 14 weeks in total, from initial screening to final follow-up.
- taking a daily dose of guanfacine XR or a placebo over a period of approximately 12 weeks;
- being engaged in treatment-as-usual, which means engaging with the YSAS intake and residential withdrawal service activities and staff, and staying connected (for counselling or other support) with YSAS or another support service during the study;
- being admitted to one of the YSAS residential withdrawal services in Fitzroy or Geelong;
- attending short weekly outpatient research assessments at a YSAS location throughout the study;
- completing research assessments at admission to the YSAS residential service and before discharge, and short (10 min) daily questionnaires during the residential stay;
- attending three longer research assessments (2-3 hours). The first will assess whether the study is a good fit for the young person, the second will assess the young person’s drug use and mental health before the start of medication, and the third will measure changes during the period that the young person is taking the study medication. These study assessments include questionnaires and interviews, some physical measurements, and collecting blood and/or urine samples.
All participants will be reimbursed for their time and related expenses.
- $50 for a screening visit;
- $60 for an initial baseline visit;
- $20 for each of the 8 short outpatient visits;
- $30 for the admission and discharge assessments during the residential stay;
- $10 per day for each of the daily assessments during the residential stay;
- $50 for the assessment 4 weeks after discharge from the residential stay; and
- $30 for an optional interview at the end of the study.
In addition, participants will receive $5 for each of the used medication packets they return to research staff at weekly visits, and $50 if they are able to remain in the residential withdrawal stay for at least 7 days.
Young people aged 12-25 who are seeking help with cannabis use and who will be receiving residential treatment at a YSAS residential withdrawal facility.
Participation in the study is completely voluntary and Orygen researchers will ensure participants have all information about the study before they provide consent.
For more details, please email [email protected] .
SEP v 2.2. HREC/ 2023-22389-36660-5