Health TrialsbyHealthPanel

Guanfacine Extended-release for Adolescents With Cannabis Use

ConditionCannabis Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-25
SponsorOrygen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

12-25 years of age (inclusive) at consent;

Seeking treatment for cannabis use;

DSM-5 Cannabis Use Disorder, mild, moderate or severe;

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

Disqualifiers

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

Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation;

Diagnosis of a psychotic or bipolar illness;

Acute suicidality as assessed by clinician;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Guanfacine Extended Release Oral Tablet

    Drug

    Target dose 4 mg daily

  • Residential withdrawal

    Behavioral

    4-14 days in residential withdrawal treatment

  • Engagement with alcohol and other drug services

    Behavioral

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

  • Placebo

    Drug

    Placebo capsule taken daily

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Guanfacine extended-releaseExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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)
4

Cannabis withdrawal symptoms during residential withdrawal admission

Measured with the Cannabis Withdrawal Scale

Time frame
Daily during residential treatment for 4 to 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orygen

Lead sponsor

Youth Support and Advocacy Service

Collaborator

University of Melbourne

Collaborator

Source ClinicalTrials.gov
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