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Guanfacine Extended-release for Adolescents With Cannabis Use

Guanfacine Extended-release for Adolescents With Cannabis Use

Recruiting
12-25 years
All
Phase 2

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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.

Eligibility

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 details
    Cannabis Use Disorder

NCT05957848

Orygen

17 June 2024

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