Guanfacine Extended-release for Adolescents With Cannabis Use

Last updated: June 11, 2024
Sponsor: Orygen
Overall Status: Active - Recruiting

Phase

2

Condition

Substance Abuse

Treatment

Guanfacine Extended Release Oral Tablet

Placebo

Residential withdrawal

Clinical Study ID

NCT05957848
22389
  • Ages 12-25
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 priorto 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/guardianconsent).

Exclusion

Exclusion Criteria:

  1. DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine;

  2. Any unstable medical, psychiatric or neurological condition or medicalcontraindicating 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 othermedications for the treatment of ADHD. If prescribed antidepressants, theparticipant 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 findingson blood tests;

  8. Pregnancy, breast feeding or, if sexually active and able to become pregnant, noeffective contraception.

  9. Intention to enter residential rehabilitation after treatment in the YSASresidential withdrawal facility.

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Guanfacine Extended Release Oral Tablet
Phase: 2
Study Start date:
July 27, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Orygen

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

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