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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
Scientific title
Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
Secondary ID [1] 0 0
22389
Universal Trial Number (UTN)
Trial acronym
GRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Use Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy - change from baseline in cannabis use frequency following monitored abstinence
Timepoint [1] 0 0
Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal
Secondary outcome [1] 0 0
Change from baseline in cannabis use frequency following monitored abstinence (categorical)
Timepoint [1] 0 0
Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal
Secondary outcome [2] 0 0
Cannabis exposure
Timepoint [2] 0 0
Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline
Secondary outcome [3] 0 0
Change from baseline in cannabis use disorder symptoms
Timepoint [3] 0 0
Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)
Secondary outcome [4] 0 0
Cannabis withdrawal symptoms during residential withdrawal admission
Timepoint [4] 0 0
Daily during residential treatment for 4 to 14 days
Secondary outcome [5] 0 0
Sleep quality (subjective) during residential withdrawal admission
Timepoint [5] 0 0
Daily during residential treatment for 4 to 14 days
Secondary outcome [6] 0 0
Cannabis craving during residential withdrawal admission
Timepoint [6] 0 0
Daily during residential treatment for 4 to 14 days
Secondary outcome [7] 0 0
Sleep quality (objective) during residential withdrawal admission
Timepoint [7] 0 0
Daily during residential treatment for 4 to 14 days
Secondary outcome [8] 0 0
Food intake during residential withdrawal admission
Timepoint [8] 0 0
Daily during residential treatment for 4 to 14 days
Secondary outcome [9] 0 0
Treatment engagement (residential)
Timepoint [9] 0 0
Baseline to end of treatment
Secondary outcome [10] 0 0
Treatment engagement (outpatient)
Timepoint [10] 0 0
Baseline to end of treatment
Secondary outcome [11] 0 0
Change from baseline in daily functioning - social and occupational
Timepoint [11] 0 0
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Secondary outcome [12] 0 0
Change from baseline in daily functioning - multidimensional
Timepoint [12] 0 0
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Secondary outcome [13] 0 0
Change from baseline in daily functioning - social inclusion
Timepoint [13] 0 0
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)

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).
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Orygen - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Orygen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Youth Support and Advocacy Service
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gillinder Bedi, DPsych
Address 0 0
Country 0 0
Phone 0 0
+61 3 9966 9100
Fax 0 0
Email 0 0
gill.bedi@orygen.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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