Orygen
Parkville, Victoria, 3052, Australia
Location status: Recruiting
Location contact
Gillinder Bedi, DPsych
CONTACT
Holly I Bowman, BPsySc(Hons)
CONTACT
NCT Number: NCT05957848
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.
Interested in participating?
Request Info12 year–25 year
All sexes
Interventional
Phase 2
Parkville, Victoria, 3052, Australia
Location status: Recruiting
Gillinder Bedi, DPsych
CONTACT
Holly I Bowman, BPsySc(Hons)
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Target dose 4 mg daily
Other names: Intuniv, Guanfacine XR
4-14 days in residential withdrawal treatment
Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study
Placebo capsule taken daily
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.
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)
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
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)
Time frame: Daily during residential treatment for 4 to 14 days
Measured with the Cannabis Withdrawal Scale
Time frame: Daily during residential treatment for 4 to 14 days
Measured with the PROMIS Sleep Disturbance Scale
Time frame: Daily during residential treatment for 4 to 14 days
Measured with the Brief Substance Craving Scale - Cannabis
Time frame: Daily during residential treatment for 4 to 14 days
Measured with wrist actigraphy
Time frame: Daily during residential treatment for 4 to 14 days
Measured with a food intake dairy
Time frame: Baseline to end of treatment
Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)
Time frame: Baseline to end of treatment
Measured as the number of outpatient alcohol and other drug counselling sessions completed
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)
Time frame: Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Measured with the Multidimensional Adolescent Functioning Scale (MAFS)
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).
Contact information is provided by the study sponsor or research team.
Emily A Karanges, PhD
CONTACT
Gillinder Bedi, DPsych
CONTACT
Orygen
Other
Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
Acronym: GRACE
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.
Published trials that share one or more normalized conditions with this study.
NCT06058702
Cannabis Use Disorder, Mental Disorders
West Haven, Connecticut, United States
View Trial DetailsNCT06891235
Cannabis Intoxication, Cannabis Use
Boston, Massachusetts, United States
View Trial DetailsNCT05453513
Behavior, Behavioral Symptoms
Miami, Florida, United States
View Trial DetailsNCT07340554
Addiction, Addiction, Substance
Indianapolis, Indiana, United States
View Trial Details