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Recruiting NCT05957848

Guanfacine Extended-release for Adolescents With Cannabis Use

Phase II Interventional Cannabis Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guanfacine Extended Release Oral Tablet, Residential withdrawal, Engagement with alcohol and other drug services, Placebo.
Who it may be relevant to
Registry conditions: Cannabis Use Disorder. Basic parameters: 12 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)

Overview

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.

Interventions

  • Drug Guanfacine Extended Release Oral Tablet
    Target dose 4 mg daily
  • Behavioral Residential withdrawal
    4-14 days in residential withdrawal treatment
  • Behavioral Engagement with alcohol and other drug services
    Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study
  • Drug Placebo
    Placebo capsule taken daily

Primary outcome measures

  • Efficacy - change from baseline in cannabis use frequency following monitored abstinence [Time frame: Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal]
Secondary outcome measures (12)
  • Change from baseline in cannabis use frequency following monitored abstinence (categorical) [Time frame: Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal]
  • Cannabis exposure [Time frame: Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline]
  • Change from baseline in cannabis use disorder symptoms [Time frame: Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)]
  • Cannabis withdrawal symptoms during residential withdrawal admission [Time frame: Daily during residential treatment for 4 to 14 days]
  • Sleep quality (subjective) during residential withdrawal admission [Time frame: Daily during residential treatment for 4 to 14 days]
  • Cannabis craving during residential withdrawal admission [Time frame: Daily during residential treatment for 4 to 14 days]
  • Sleep quality (objective) during residential withdrawal admission [Time frame: Daily during residential treatment for 4 to 14 days]
  • Food intake during residential withdrawal admission [Time frame: Daily during residential treatment for 4 to 14 days]
  • Treatment engagement (residential) [Time frame: Baseline to end of treatment]
  • Treatment engagement (outpatient) [Time frame: Baseline to end of treatment]
  • Change from baseline in daily functioning - social and occupational [Time frame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)]
  • Change from baseline in daily functioning - multidimensional [Time frame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Orygen — Parkville

Identifiers

NCT: NCT05957848 · 22389

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗