Guanfacine Extended-release for Adolescents With Cannabis Use

NCT ID: NCT05957848

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Guanfacine extended-release

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

Group Type EXPERIMENTAL

Guanfacine Extended Release Oral Tablet

Intervention Type DRUG

Target dose 4 mg daily

Residential withdrawal

Intervention Type BEHAVIORAL

4-14 days in residential withdrawal treatment

Engagement with alcohol and other drug services

Intervention Type BEHAVIORAL

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

Group Type PLACEBO_COMPARATOR

Residential withdrawal

Intervention Type BEHAVIORAL

4-14 days in residential withdrawal treatment

Engagement with alcohol and other drug services

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type DRUG

Placebo capsule taken daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guanfacine Extended Release Oral Tablet

Target dose 4 mg daily

Intervention Type DRUG

Residential withdrawal

4-14 days in residential withdrawal treatment

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Placebo

Placebo capsule taken daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intuniv Guanfacine XR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Youth Support and Advocacy Service

UNKNOWN

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role collaborator

Orygen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orygen

Parkville, Victoria, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gillinder Bedi, DPsych

Role: CONTACT

+61 3 9966 9100

Emily A Karanges, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gillinder Bedi, DPsych

Role: primary

+61 3 9966 9100

Holly I Bowman, BPsySc(Hons)

Role: backup

+61 3 9966 9100

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22389

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Regulated Cannabis Access in Basel
NCT05522205 ACTIVE_NOT_RECRUITING NA
Effects of THC on Emotional Memory Retrieval
NCT03471585 COMPLETED EARLY_PHASE1
Effects of Dronabinol (Oral THC) on Cannabis Use
NCT01394185 COMPLETED PHASE1/PHASE2
Drug-Drug Interaction Between THC and AEF0117
NCT06395688 NOT_YET_RECRUITING PHASE1
Cannabinoids, Learning, and Memory
NCT02407808 ACTIVE_NOT_RECRUITING PHASE1
Reward and Drug Effects on Mood and Brain Response
NCT04512365 COMPLETED EARLY_PHASE1
Cannabis Effects on Electroencephalography
NCT04316598 TERMINATED PHASE1
Pharmacogenetics of Cannabinoid Response
NCT00678730 COMPLETED EARLY_PHASE1