Guanfacine Extended-release for Adolescents With Cannabis Use

Cannabis Use Disorder Clinical Trial

— GRACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957848
• Other study ID #: 22389
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Orygen
• Contact: Gillinder Bedi, DPsych
• Phone: +61 3 9966 9100
• Email: gill.bedi[@]orygen.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Drug:
• Guanfacine Extended Release Oral Tablet
Target dose 4 mg daily

Behavioral:
• Residential withdrawal
4-14 days in residential withdrawal treatment
• 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

Locations

Country	Name	City	State
Australia	Orygen	Parkville	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Orygen	University of Melbourne, Youth Support and Advocacy Service

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal
Secondary	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)	Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal
Secondary	Cannabis exposure	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
Secondary	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)	Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)
Secondary	Cannabis withdrawal symptoms during residential withdrawal admission	Measured with the Cannabis Withdrawal Scale	Daily during residential treatment for 4 to 14 days
Secondary	Sleep quality (subjective) during residential withdrawal admission	Measured with the PROMIS Sleep Disturbance Scale	Daily during residential treatment for 4 to 14 days
Secondary	Cannabis craving during residential withdrawal admission	Measured with the Brief Substance Craving Scale - Cannabis	Daily during residential treatment for 4 to 14 days
Secondary	Sleep quality (objective) during residential withdrawal admission	Measured with wrist actigraphy	Daily during residential treatment for 4 to 14 days
Secondary	Food intake during residential withdrawal admission	Measured with a food intake dairy	Daily during residential treatment for 4 to 14 days
Secondary	Treatment engagement (residential)	Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)	Baseline to end of treatment
Secondary	Treatment engagement (outpatient)	Measured as the number of outpatient alcohol and other drug counselling sessions completed	Baseline to end of treatment
Secondary	Change from baseline in daily functioning - social and occupational	Measured with the Social and Occupational Functioning Assessment scale (SOFAS)	Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Secondary	Change from baseline in daily functioning - multidimensional	Measured with the Multidimensional Adolescent Functioning Scale (MAFS)	Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)
Secondary	Change from baseline in daily functioning - social inclusion	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)