Guanfacine Extended-release for Adolescents With Cannabis Use
Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
Orygen
100 participants
Jul 27, 2023
INTERVENTIONAL
Conditions
Summary
A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.
Eligibility
Inclusion Criteria5
- 12-25 years of age (inclusive) at consent;
- Seeking treatment for cannabis use;
- DSM-5 Cannabis Use Disorder, mild, moderate or severe;
- 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
- 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 Criteria9
- DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine;
- Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation;
- Diagnosis of a psychotic or bipolar illness;
- Acute suicidality as assessed by clinician;
- 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;
- A history of heart disease or cardiac risk factors (e.g. arrhythmias);
- Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests;
- Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception.
- Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.
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Interventions
Target dose 4 mg daily
4-14 days in residential withdrawal treatment
Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study
Placebo capsule taken daily
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05957848