Using guanfacine to help adolescents reduce cannabis use
Official title: Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
Run by Orygen · NCT05957848 · Data updated 2026-11-12
This study is testing if a medication called guanfacine can help young people aged 12 to 25 cut down on their cannabis use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Orygen Academic / other |
| Locations | 1 site (Parkville, Victoria) |
| Status | Recruiting |
| Started | July 27, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT05957848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adolescents and young adults aged 12 to 25 who are seeking treatment for cannabis use and meet the criteria for cannabis use disorder.
✕Probably not a fit
Patients with severe substance use disorders other than cannabis or those with unstable medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized controlled trial designed to evaluate the effectiveness of extended-release guanfacine in decreasing the frequency of cannabis use among adolescents and young adults diagnosed with cannabis use disorder. Participants aged 12 to 25 will undergo a period of monitored abstinence before receiving either guanfacine or a placebo. The study aims to assess changes in cannabis use frequency following treatment. The trial will also involve engagement with alcohol and other drug services to support participants during the intervention.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for adolescents struggling with cannabis use disorder.
How similar studies have gone: While this approach is relatively novel, previous studies have explored pharmacological interventions for substance use disorders, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 12-25 years of age (inclusive) at consent; 2. Seeking treatment for cannabis use; 3. DSM-5 Cannabis Use Disorder, mild, moderate or severe; 4. Self-reported cannabis use on average at least 5 days/week during the 28 days prior to screening with a THC positive urine drug screen on the day of screening; and 5. Able to provide informed consent (both adequate IQ and English fluency; \<18-year-olds will provide consent themselves in addition to parent/guardian consent). Exclusion Criteria: 1. DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine; 2. Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation; 3. Diagnosis of a psychotic or bipolar illness; 4. Acute suicidality as assessed by clinician; 5. Prescribed antipsychotics, benzodiazepines or other sedative medications, or other medications for the treatment of ADHD. If prescribed antidepressants, the participant must have been on a stable dose for more than 2 weeks at screening; 6. A history of heart disease or cardiac risk factors (e.g. arrhythmias); 7. Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests; 8. Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception. 9. Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.
Where it's running
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Orygen
Parkville, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Gillinder Bedi, DPsych
- Email: gill.bedi@orygen.org.au
- Phone: +61 3 9966 9100
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Can tACS modulate motivation and reward signals in cannabis use disorder and depression
We’re testing whether a gentle brain stimulation method (tACS) can boost motivation and reward responses in adults with cannabis use and/or depression to see if it helps with anhedonia.
-
Sex differences in how cannabis affects people who regularly use it
This Phase 2 trial tests whether men and women who use cannabis several days a week respond differently to THC versus placebo.
-
Semaglutide for cannabis use disorder: see if a medicine helps reduce use
This study tests whether weekly injections of semaglutide can help adults with cannabis use disorder reduce their cannabis use compared with placebo.
-
Brain imaging to predict teens' response to cannabis treatment
This project will test whether teens' brain activity during a learning task can predict how well 14–17-year-olds do in a 10-week virtual reward program to reduce cannabis use.
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Reducing cannabis use to improve daily functioning.
This program will try an 8-week combination of motivational interviewing, computerized CBT (CBT4CBT), and small financial rewards to help adults with cannabis use disorder cut back on cannabis.
-
Home-based brain stimulation with guided mindfulness for cannabis use disorder
This project tests whether daily at-home mild brain stimulation plus guided mindfulness can help adults with cannabis use disorder reduce or stop their cannabis use.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.