Clinical trial NCT05957848: Guanfacine Extended-release for Adolescents With Cannabis Use
Official title: Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cannabis Use Disorder
Lead sponsor: Orygen
Sponsor class: OTHER
Collaborators: name: Youth Support and Advocacy Service
name: University of Melbourne
First posted: 2023-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Efficacy - change from baseline in cannabis use frequency following monitored abstinence
timeFrame: Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal
Secondary outcomes:
measure: Change from baseline in cannabis use frequency following monitored abstinence (categorical)
timeFrame: Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal
measure: Cannabis exposure
timeFrame: Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline
measure: Change from baseline in cannabis use disorder symptoms
timeFrame: Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)
measure: Cannabis withdrawal symptoms during residential withdrawal admission
timeFrame: Daily during residential treatment for 4 to 14 days
measure: Sleep quality (subjective) during residential withdrawal admission
timeFrame: Daily during residential treatment for 4 to 14 days
measure: Cannabis craving during residential withdrawal admission
timeFrame: Daily during residential treatment for 4 to 14 days
measure: Sleep quality (objective) during residential withdrawal admission
timeFrame: Daily during residential treatment for 4 to 14 days
measure: Food intake during residential withdrawal admission
timeFrame: Daily during residential treatment for 4 to 14 days
measure: Treatment engagement (residential)
timeFrame: Baseline to end of treatment
measure: Treatment engagement (outpatient)
timeFrame: Baseline to end of treatment
measure: Change from baseline in daily functioning - social and occupational
timeFrame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
measure: Change from baseline in daily functioning - multidimensional
timeFrame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
measure: Change from baseline in daily functioning - social inclusion
timeFrame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Orygen
state: Victoria
Study officials:
References: