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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05957848
Registration number
NCT05957848
Ethics application status
Date submitted
15/06/2023
Date registered
24/07/2023
Titles & IDs
Public title
Guanfacine Extended-release for Adolescents With Cannabis Use
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Scientific title
Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
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Secondary ID [1]
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22389
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Universal Trial Number (UTN)
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Trial acronym
GRACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cannabis Use Disorder
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Condition category
Condition code
Mental Health
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guanfacine Extended Release Oral Tablet
BEHAVIORAL - Residential withdrawal
BEHAVIORAL - Engagement with alcohol and other drug services
Treatment: Drugs - Placebo
Experimental: Guanfacine extended-release - Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Placebo comparator: Placebo - Placebo once daily for approximately 12 weeks plus treatment as usual
Treatment: Drugs: 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
Treatment: Drugs: Placebo
Placebo capsule taken daily
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy - change from baseline in cannabis use frequency following monitored abstinence
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal
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Secondary outcome [1]
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Change from baseline in cannabis use frequency following monitored abstinence (categorical)
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Assessment method [1]
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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)
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Timepoint [1]
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Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal
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Secondary outcome [2]
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Cannabis exposure
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Assessment method [2]
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The number of urine toxicology tests that are positive for cannabis exposure
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Timepoint [2]
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Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline
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Secondary outcome [3]
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Change from baseline in cannabis use disorder symptoms
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Assessment method [3]
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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)
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Timepoint [3]
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Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)
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Secondary outcome [4]
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Cannabis withdrawal symptoms during residential withdrawal admission
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Assessment method [4]
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Measured with the Cannabis Withdrawal Scale
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Timepoint [4]
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Daily during residential treatment for 4 to 14 days
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Secondary outcome [5]
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Sleep quality (subjective) during residential withdrawal admission
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Assessment method [5]
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Measured with the PROMIS Sleep Disturbance Scale
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Timepoint [5]
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Daily during residential treatment for 4 to 14 days
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Secondary outcome [6]
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Cannabis craving during residential withdrawal admission
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Assessment method [6]
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Measured with the Brief Substance Craving Scale - Cannabis
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Timepoint [6]
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Daily during residential treatment for 4 to 14 days
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Secondary outcome [7]
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Sleep quality (objective) during residential withdrawal admission
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Assessment method [7]
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Measured with wrist actigraphy
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Timepoint [7]
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Daily during residential treatment for 4 to 14 days
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Secondary outcome [8]
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Food intake during residential withdrawal admission
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Assessment method [8]
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Measured with a food intake dairy
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Timepoint [8]
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Daily during residential treatment for 4 to 14 days
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Secondary outcome [9]
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Treatment engagement (residential)
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Assessment method [9]
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Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)
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Timepoint [9]
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Baseline to end of treatment
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Secondary outcome [10]
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Treatment engagement (outpatient)
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Assessment method [10]
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Measured as the number of outpatient alcohol and other drug counselling sessions completed
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Timepoint [10]
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Baseline to end of treatment
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Secondary outcome [11]
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Change from baseline in daily functioning - social and occupational
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Assessment method [11]
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Measured with the Social and Occupational Functioning Assessment scale (SOFAS)
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Timepoint [11]
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Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
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Secondary outcome [12]
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Change from baseline in daily functioning - multidimensional
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Assessment method [12]
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Measured with the Multidimensional Adolescent Functioning Scale (MAFS)
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Timepoint [12]
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Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
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Secondary outcome [13]
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Change from baseline in daily functioning - social inclusion
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Assessment method [13]
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Measured with the Filia Social Inclusion Measure - 16 item scale (FSIM-16).
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Timepoint [13]
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Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
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Eligibility
Key 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).
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Minimum age
12
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Orygen - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Orygen
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Youth Support and Advocacy Service
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05957848
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gillinder Bedi, DPsych
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Address
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Country
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Phone
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+61 3 9966 9100
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05957848