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Alpha-2 Adrenergic Agonist

Guanfacine-ER for Cannabis Use Disorder

Phase 2

Waitlist Available

Led By Christina Brezing, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity that can result in pregnancy

Bradycardia (< 50 beats/minute), hypotension (sitting or standing BP < 90/50), or symptoms attributable to hypotension (i.e. lightheadedness or dizziness on standing)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks of study

Summary

This trial tests Guanfacine-ER, a slow-releasing medication, on people with Cannabis Use Disorder to see if it helps them reduce cannabis use. The medication works by calming brain activity, which can help manage impulsive behaviors and withdrawal symptoms. Guanfacine-ER has been shown to improve symptoms in children and adolescents with ADHD and oppositional defiant disorder.

Who is the study for?

This trial is for individuals who have a cannabis use disorder, are seeking treatment to reduce or stop their use, and can give informed consent. They must test positive for THC, be able to receive mail, and have internet access. Excluded are those with certain mental health conditions, on incompatible medications or treatments, pregnant or not using contraception if at risk of pregnancy.

What is being tested?

The study tests whether guanfacine-ER helps people cut down or quit cannabis by reducing impulsivity and withdrawal symptoms. Participants will either get the actual drug or a placebo without knowing which one they're taking. The trial includes both in-person visits and virtual check-ins.

What are the potential side effects?

Potential side effects of guanfacine-ER may include low blood pressure (hypotension), slow heart rate (bradycardia), dizziness especially when standing up due to low blood pressure, as well as possible allergic reactions in those sensitive to the medication.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and I use effective birth control.

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I have a slow heartbeat, low blood pressure, or feel dizzy when standing.

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I am taking blood pressure medicine that might interact with guanfacine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in daily cannabis use as measured by ecological momentary assessments (EMA).

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Guanfacine-ERExperimental Treatment1 Intervention

Participants will start on guanfacine-ER 1mg nightly for 1-week (week 1) and slowly increase by 1mg/per week to a max dose of 4mg per day or maximum dose as tolerated. Medication taper to discontinuation will begin in week 11 and continue into week 12 until complete by end of study, decreasing the dose by 1mg every 4 days until stopped.

Group II: PlaceboPlacebo Group1 Intervention

Placebo will be taken nightly and titrated and tapered similar to the active arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

guanfacine-ER

2022

Completed Phase 2

~30

0 / 3Eligibility criteria met