Guanfacine Extended-release for Adolescents With Cannabis Use

NCT05957848 | Recruiting Phase 2 DMC

• 1 other identifier: 22389
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change from baseline in cannabis use frequency following monitored abstinence (categorical)

  Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal

• Cannabis exposure

  Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline

• Change from baseline in cannabis use disorder symptoms

  Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal)

• Cannabis withdrawal symptoms during residential withdrawal admission

  Daily during residential treatment for 4 to 14 days

• Sleep quality (subjective) during residential withdrawal admission

  Daily during residential treatment for 4 to 14 days

Study Arms (2)

Guanfacine extended-release

EXPERIMENTAL

Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual

Drug: Guanfacine Extended Release Oral Tablet; Behavioral: Residential withdrawal; Behavioral: Engagement with alcohol and other drug services

Placebo

PLACEBO COMPARATOR

Placebo once daily for approximately 12 weeks plus treatment as usual

Behavioral: Residential withdrawal; Behavioral: Engagement with alcohol and other drug services; Drug: Placebo

Interventions

Guanfacine Extended Release Oral Tablet DRUG

Target dose 4 mg daily

Also known as: Intuniv, Guanfacine XR

Guanfacine extended-release

Residential withdrawal BEHAVIORAL

4-14 days in residential withdrawal treatment

Guanfacine extended-release; Placebo

Engagement with alcohol and other drug services BEHAVIORAL

Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study

Guanfacine extended-release; Placebo

Placebo DRUG

Placebo capsule taken daily

Placebo

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Orygen: lead
• Youth Support and Advocacy Service: collaborator
• University of Melbourne: collaborator

Study Sites (1)

Orygen

Parkville, Victoria, 3052, Australia

RECRUITING

MeSH Terms

Interventions

Guanfacine; Ethanol

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Alcohols

Central Study Contacts

Gillinder Bedi, DPsych

CONTACT

+61 3 9966 9100; gill.bedi@orygen.org.au

Emily A Karanges, PhD

CONTACT

emily.karanges@orygen.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 24, 2023
• Study Start: July 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)