Guanfacine Extended-release for Adolescents With Cannabis Use

Phase 2

Recruiting

• Conditions: Cannabis Use Disorder
• Interventions: Drug: Guanfacine Extended Release Oral Tablet; Behavioral: Residential withdrawal; Behavioral: Engagement with alcohol and other drug services; Drug: Placebo

• Registration Number: NCT05957848
• Lead Sponsor: Orygen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-07-16
• Study First Posted: 2023-07-24
• Study Start: 2023-07-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guanfacine extended-release	Residential withdrawal	Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Guanfacine extended-release	Engagement with alcohol and other drug services	Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Placebo	Residential withdrawal	Placebo once daily for approximately 12 weeks plus treatment as usual
Placebo	Engagement with alcohol and other drug services	Placebo once daily for approximately 12 weeks plus treatment as usual
Placebo	Placebo	Placebo once daily for approximately 12 weeks plus treatment as usual
Guanfacine extended-release	Guanfacine Extended Release Oral Tablet	Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual

Primary Outcome Measures

Name	Time	Method
Efficacy - change from baseline in cannabis use frequency following monitored abstinence	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in cannabis use frequency following monitored abstinence (categorical)	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)
Sleep quality (subjective) during residential withdrawal admission	Daily during residential treatment for 4 to 14 days	Measured with the PROMIS Sleep Disturbance Scale
Sleep quality (objective) during residential withdrawal admission	Daily during residential treatment for 4 to 14 days	Measured with wrist actigraphy
Food intake during residential withdrawal admission	Daily during residential treatment for 4 to 14 days	Measured with a food intake dairy
Treatment engagement (outpatient)	Baseline to end of treatment	Measured as the number of outpatient alcohol and other drug counselling sessions completed
Change from baseline in daily functioning - social inclusion	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).
Change from baseline in cannabis use disorder symptoms	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)
Treatment engagement (residential)	Baseline to end of treatment	Measured as the longest consecutive length of stay in residential withdrawal (4-14 days)
Change from baseline in daily functioning - social and occupational	Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)	Measured with the Social and Occupational Functioning Assessment scale (SOFAS)
Change from baseline in daily functioning - multidimensional	Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal)	Measured with the Multidimensional Adolescent Functioning Scale (MAFS)
Cannabis exposure	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
Cannabis withdrawal symptoms during residential withdrawal admission	Daily during residential treatment for 4 to 14 days	Measured with the Cannabis Withdrawal Scale
Cannabis craving during residential withdrawal admission	Daily during residential treatment for 4 to 14 days	Measured with the Brief Substance Craving Scale - Cannabis

Trial Locations

Locations (1)

Orygen; 🇦🇺 Parkville, Victoria, Australia