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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks of study
Awards & highlights

Study Summary

This trial is investigating whether the drug guanfacine-ER can help people with Cannabis Use Disorder by reducing cannabis use and withdrawal symptoms, as well as impulsivity. The trial is conducted both in person and virtually, to assess the feasibility of the virtual components.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,817 Total Patients Enrolled
3 Trials studying Cannabis Use
176 Patients Enrolled for Cannabis Use
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,503 Total Patients Enrolled
28 Trials studying Cannabis Use
6,067 Patients Enrolled for Cannabis Use
Christina Brezing, MDPrincipal InvestigatorNYSPI
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Guanfacine-ER (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05273567 — Phase 2
Cannabis Use Research Study Groups: Guanfacine-ER, Placebo
Cannabis Use Clinical Trial 2023: Guanfacine-ER Highlights & Side Effects. Trial Name: NCT05273567 — Phase 2
Guanfacine-ER (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05273567 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people who are over 25 years old being recruited for this medical trial?

"This trial is for patients that are within the age bracket of 18 to 65 years old. If a patient does not meet this age requirement, there are 50 other studies that they could potentially enroll in."

Answered by AI

Has guanfacine-ER passed government regulations for public consumption?

"While there is some evidence to support the safety of guanfacine-ER, it received a score of 2 because this Phase 2 trial has yet to produce data confirming its efficacy."

Answered by AI

Are new applicants still being accepted into this medical study?

"That is correct. Currently, the website clinicaltrials.gov is suggesting that this trial is recruiting patients. This specific trial was first posted on 6/1/2022 and was updated recently on 6/6/2022. They are searching for a total of 90 patients between 1 locations."

Answered by AI

How many people have signed up for this clinical trial thus far?

"That is correct, the information available on clinicaltrials.gov currently indicates that this trial is still recruiting patients. This particular study was first posted on June 1st, 2022 and was last edited on June 6th, 2022. They are looking for a total of 90 individuals between 1 site."

Answered by AI

How can I sign up for this opportunity to test a new medication?

"This study is looking for 90 individuals that fit the following criteria: currently use cannabis, between 18-65 years old, meets DSM-V criteria for a current cannabis use disorder, seeking treatment to reduce or stop cannabis use, THC-positive drug screen, able to give informed consent and comply with study procedures, has internet access and devices needed to complete study procedures, capability of receiving mailed packages for study supplies."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Massachusetts
New York
How old are they?
18 - 65
What site did they apply to?
STARS Clinic at Columbia and NYSPI Department of Psychiatry
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have tried quitting several times and have not been successful. I’d like to be drug free for my kids and my personal well being.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Trial of Guanfacine-er for Cannabis Use Disorder
Christina Ann Brezing 2022. "A Trial of Guanfacine-er for Cannabis Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05273567.
All > Cannabis
~27 spots leftby Mar 2025
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