Guanfacine Extended-release for Adolescents With Cannabis Use (GRACE)

July 29, 2025 updated by: Orygen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Guanfacine extended-release
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Drug: Guanfacine Extended Release Oral Tablet
Target dose 4 mg daily
Other Names:
  • Intuniv
  • Guanfacine XR
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
Placebo Comparator: Placebo
Placebo once daily for approximately 12 weeks plus treatment as usual
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
The number of urine toxicology tests that are positive for cannabis exposure
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)
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)
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
Measured with the Cannabis Withdrawal Scale
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
Measured with the PROMIS Sleep Disturbance Scale
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
Measured with the Brief Substance Craving Scale - Cannabis
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
Measured with wrist actigraphy
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
Measured with a food intake dairy
Daily during residential treatment for 4 to 14 days
Treatment engagement (residential)
Time Frame: Baseline to end of treatment
Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)
Baseline to end of treatment
Treatment engagement (outpatient)
Time Frame: Baseline to end of treatment
Measured as the number of outpatient alcohol and other drug counselling sessions completed
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)
Measured with the Social and Occupational Functioning Assessment scale (SOFAS)
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)
Measured with the Multidimensional Adolescent Functioning Scale (MAFS)
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
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).
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orygen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Melbourne
Youth Support and Advocacy Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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