Back to resultsGuanfacine Extended-release for Adolescents With Cannabis Use (GRACE)
Primary Purpose
Cannabis Use Disorder
Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Guanfacine Extended Release Oral Tablet
Residential withdrawal
Engagement with alcohol and other drug services
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use Disorder
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; Severe depression (>15 on the Quick Inventory of Depression Symptomatology; QIDS); 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.
Sites / Locations
- OrygenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Guanfacine extended-release
Placebo
Arm Description
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Placebo once daily for approximately 12 weeks plus treatment as usual
Outcomes
Primary Outcome Measures
Efficacy - change from baseline in cannabis use frequency following monitored abstinence
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 Outcome Measures
Change from baseline in cannabis use frequency following monitored abstinence (categorical)
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)
Cannabis exposure
The number of urine toxicology tests that are positive for cannabis exposure
Change from baseline in cannabis use disorder symptoms
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)
Cannabis withdrawal symptoms during residential withdrawal admission
Measured with the Cannabis Withdrawal Scale
Sleep quality (subjective) during residential withdrawal admission
Measured with the PROMIS Sleep Disturbance Scale
Cannabis craving during residential withdrawal admission
Measured with the Brief Substance Craving Scale - Cannabis
Sleep quality (objective) during residential withdrawal admission
Measured with wrist actigraphy
Food intake during residential withdrawal admission
Measured with a food intake dairy
Treatment engagement (residential)
Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)
Treatment engagement (outpatient)
Measured as the number of outpatient alcohol and other drug counselling sessions completed
Change from baseline in daily functioning - social and occupational
Measured with the Social and Occupational Functioning Assessment scale (SOFAS)
Change from baseline in daily functioning - multidimensional
Measured with the Multidimensional Adolescent Functioning Scale (MAFS)
Change from baseline in daily functioning - social inclusion
Measured with the Filia Social Inclusion Measure - 16 item scale (FSIM-16).
Full Information
NCT ID
NCT05957848
First Posted
June 15, 2023
Last Updated
August 21, 2023
Sponsor
Orygen
Collaborators
Youth Support and Advocacy Service, University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT05957848
Brief Title
Guanfacine Extended-release for Adolescents With Cannabis Use
Acronym
GRACE
Official Title
Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orygen
Collaborators
Youth Support and Advocacy Service, University of Melbourne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guanfacine extended-release
Arm Type
Experimental
Arm Description
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for approximately 12 weeks plus treatment as usual
Intervention Type
Drug
Intervention Name(s)
Guanfacine Extended Release Oral Tablet
Other Intervention Name(s)
Intuniv, Guanfacine XR
Intervention Description
Target dose 4 mg daily
Intervention Type
Behavioral
Intervention Name(s)
Residential withdrawal
Intervention Description
4-14 days in residential withdrawal treatment
Intervention Type
Behavioral
Intervention Name(s)
Engagement with alcohol and other drug services
Intervention Description
Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule taken daily
Primary Outcome Measure Information:
Title
Efficacy - change from baseline in cannabis use frequency following monitored abstinence
Description
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.
Time Frame
Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal
Secondary Outcome Measure Information:
Title
Change from baseline in cannabis use frequency following monitored abstinence (categorical)
Description
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)
Time Frame
Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal
Title
Cannabis exposure
Description
The number of urine toxicology tests that are positive for cannabis exposure
Time Frame
Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline
Title
Change from baseline in cannabis use disorder symptoms
Description
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)
Time Frame
Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)
Title
Cannabis withdrawal symptoms during residential withdrawal admission
Description
Measured with the Cannabis Withdrawal Scale
Time Frame
Daily during residential treatment for 4 to 14 days
Title
Sleep quality (subjective) during residential withdrawal admission
Description
Measured with the PROMIS Sleep Disturbance Scale
Time Frame
Daily during residential treatment for 4 to 14 days
Title
Cannabis craving during residential withdrawal admission
Description
Measured with the Brief Substance Craving Scale - Cannabis
Time Frame
Daily during residential treatment for 4 to 14 days
Title
Sleep quality (objective) during residential withdrawal admission
Description
Measured with wrist actigraphy
Time Frame
Daily during residential treatment for 4 to 14 days
Title
Food intake during residential withdrawal admission
Description
Measured with a food intake dairy
Time Frame
Daily during residential treatment for 4 to 14 days
Title
Treatment engagement (residential)
Description
Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)
Time Frame
Baseline to end of treatment
Title
Treatment engagement (outpatient)
Description
Measured as the number of outpatient alcohol and other drug counselling sessions completed
Time Frame
Baseline to end of treatment
Title
Change from baseline in daily functioning - social and occupational
Description
Measured with the Social and Occupational Functioning Assessment scale (SOFAS)
Time Frame
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Title
Change from baseline in daily functioning - multidimensional
Description
Measured with the Multidimensional Adolescent Functioning Scale (MAFS)
Time Frame
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Title
Change from baseline in daily functioning - social inclusion
Description
Measured with the Filia Social Inclusion Measure - 16 item scale (FSIM-16).
Time Frame
Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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;
Severe depression (>15 on the Quick Inventory of Depression Symptomatology; QIDS);
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gillinder Bedi, DPsych
Phone
+61 3 9966 9100
Email
gill.bedi@orygen.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Emily A Karanges, PhD
Email
emily.karanges@orygen.org.au
Facility Information:
Facility Name
Orygen
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gillinder Bedi, DPsych
Phone
+61 3 9966 9100
Email
gill.bedi@orygen.org.au
First Name & Middle Initial & Last Name & Degree
Holly I Bowman, BPsySc(Hons)
Phone
+61 3 9966 9100
Email
holly.bowman@orygen.org.au
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Guanfacine Extended-release for Adolescents With Cannabis Use
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