Guanfacine Extended-release for Adolescents With Cannabis Use

Phase 2RecruitingNCT05957848

Orygen100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Cannabis Use Disorder

Interventions

Guanfacine Extended Release Oral TabletDRUG

Target dose 4 mg daily

Residential withdrawalBEHAVIORAL

4-14 days in residential withdrawal treatment

Engagement with alcohol and other drug servicesBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Locations (1)

Orygen

Parkville, Victoria, Australia

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal

Secondary Outcomes

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)

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

Cannabis exposure

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

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)

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

Cannabis withdrawal symptoms during residential withdrawal admission

Measured with the Cannabis Withdrawal Scale

Time frame: Daily during residential treatment for 4 to 14 days

Central Contacts

Gillinder Bedi, DPsych

CONTACT

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

Emily A Karanges, PhD

CONTACT

emily.karanges@orygen.org.au

Data from ClinicalTrials.gov

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