Guanfacine Extended-release for Adolescents With Cannabis Use
NCT ID: NCT05957848
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2023-07-27
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Guanfacine extended-release
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
Guanfacine Extended Release Oral Tablet
Target dose 4 mg daily
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
Placebo
Placebo once daily for approximately 12 weeks plus treatment as usual
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
Placebo
Placebo capsule taken daily
Interventions
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Guanfacine Extended Release Oral Tablet
Target dose 4 mg daily
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
Placebo
Placebo capsule taken daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
25 Years
ALL
No
Sponsors
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Youth Support and Advocacy Service
UNKNOWN
University of Melbourne
OTHER
Orygen
OTHER
Responsible Party
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Locations
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Orygen
Parkville, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22389
Identifier Type: -
Identifier Source: org_study_id
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