Guanfacine Extended-release for Adolescents With Cannabis Use (GRACE)

Orygen

Status and phase: Enrolling; Phase 2

Conditions: Cannabis Use Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05957848

22389

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Guanfacine extended-release

Experimental group

Description:

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

Treatment:

Behavioral: Engagement with alcohol and other drug services

Drug: Guanfacine Extended Release Oral Tablet

Behavioral: Residential withdrawal

Placebo

Placebo Comparator group

Description:

Placebo once daily for approximately 12 weeks plus treatment as usual

Treatment:

Behavioral: Engagement with alcohol and other drug services

Behavioral: Residential withdrawal

Drug: Placebo