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NCT Number: NCT05957848

Guanfacine Extended-release for Adolescents With Cannabis Use

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.

Recruiting

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Key information

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guanfacine Extended Release Oral Tablet

Drug

Target dose 4 mg daily

Other names: Intuniv, Guanfacine XR

Residential withdrawal

Behavioral

4-14 days in residential withdrawal treatment

Engagement with alcohol and other drug services

Behavioral

Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study

Placebo

Drug

Placebo capsule taken daily

Primary outcomes

  1. 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

    Change from baseline in average frequency of cannabis use (days of use/week) in the 4 weeks immediately following discharge from residential withdrawal, assessed weekly using the Timeline Follow-Back.

Secondary outcomes

  1. 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

    Change from baseline in average frequency of cannabis use in the 4 weeks immediately following discharge from residential withdrawal, assessed weekly using the Timeline Follow-Back and categorized as follows: heavy use (5-7 days per week), moderate use (3-5 days) or light use (0-1 days)

  2. Cannabis exposure

    Time frame: Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline

    The number of urine toxicology tests that are positive for cannabis exposure

  3. Change from baseline in cannabis use disorder symptoms

    Time frame: Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)

    Change from baseline in number of cannabis use disorder symptoms endorsed at end of treatment as indexed by the Structured Clinical Interview for DSM-5 (SCID-5)

  4. Cannabis withdrawal symptoms during residential withdrawal admission

    Time frame: Daily during residential treatment for 4 to 14 days

    Measured with the Cannabis Withdrawal Scale

  5. Sleep quality (subjective) during residential withdrawal admission

    Time frame: Daily during residential treatment for 4 to 14 days

    Measured with the PROMIS Sleep Disturbance Scale

  6. Cannabis craving during residential withdrawal admission

    Time frame: Daily during residential treatment for 4 to 14 days

    Measured with the Brief Substance Craving Scale - Cannabis

  7. Sleep quality (objective) during residential withdrawal admission

    Time frame: Daily during residential treatment for 4 to 14 days

    Measured with wrist actigraphy

  8. Food intake during residential withdrawal admission

    Time frame: Daily during residential treatment for 4 to 14 days

    Measured with a food intake dairy

  9. Treatment engagement (residential)

    Time frame: Baseline to end of treatment

    Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)

  10. Treatment engagement (outpatient)

    Time frame: Baseline to end of treatment

    Measured as the number of outpatient alcohol and other drug counselling sessions completed

  11. 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)

    Measured with the Social and Occupational Functioning Assessment scale (SOFAS)

  12. Change from baseline in daily functioning - multidimensional

    Time frame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)

    Measured with the Multidimensional Adolescent Functioning Scale (MAFS)

  13. Change from baseline in daily functioning - social inclusion

    Time frame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)

    Measured with the Filia Social Inclusion Measure - 16 item scale (FSIM-16).

Study contacts

Contact information is provided by the study sponsor or research team.

Emily A Karanges, PhD

CONTACT

[email protected]

Gillinder Bedi, DPsych

CONTACT

[email protected]

+61 3 9966 9100

Sponsors and collaborators

Lead sponsor

Orygen

Other

Collaborators

  • University of Melbourne
  • Youth Support and Advocacy Service

Registry information

Official study title

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

Acronym: GRACE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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