Guanfacine-ER for Cannabis Use Disorder

Overseen By Daniel Brooks, LCSW

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: New York State Psychiatric Institute

Must not be taking: Alpha 2 agonists, others

Disqualifiers: Schizophrenia, Pregnancy, Violent behavior, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain medications that interact with guanfacine, like some antihypertensives and specific drugs such as rifampicin, ketoconazole, St. John's Wort, and amitriptyline. If you are stable on psychotropic medication for at least 2 months and it is compatible with guanfacine, you may still be eligible.

What data supports the effectiveness of the drug Guanfacine-ER for treating cannabis use disorder?

Research shows that Guanfacine can help reduce irritability and improve sleep during cannabis withdrawal, and a pilot study found that Guanfacine-ER reduced cannabis use over time. These findings suggest it may be helpful in managing symptoms of cannabis use disorder. ^{1 2 3 4 5}

Is Guanfacine-ER safe for humans?

Guanfacine-ER has been studied for safety in both cannabis use disorder and ADHD. In cannabis use disorder trials, it was generally well tolerated with minor side effects like small decreases in blood pressure. In ADHD studies, common side effects included sleepiness, headache, and fatigue, but serious side effects were rare. ^{1 4 5 6 7}

How does the drug Guanfacine-ER differ from other treatments for cannabis use disorder?

Guanfacine-ER is unique because it is a long-acting alpha-2-adrenergic receptor agonist that may help reduce withdrawal symptoms and improve behavioral control in cannabis use disorder, whereas there are currently no established medications specifically approved for this condition. ^{1 2 4 5 8}

What is the purpose of this trial?

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.

Research Team

Christina Brezing, MD

Principal Investigator

NYSPI

Eligibility Criteria

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.

Inclusion Criteria

Meets DSM-V criteria for a current cannabis use disorder

I can receive packages by mail for study needs.

Capable of giving informed consent and complying with study procedures

Exclusion Criteria

Legally mandated to participate in a substance use disorder treatment program

Any medical or psychiatric conditions that in the investigator's judgment would interfere with safe participation in the study will be exclusionary

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guanfacine-ER or placebo, starting at 1mg nightly and increasing to a maximum of 4mg, with a tapering phase starting in week 11

12 weeks

4 visits (in-person), multiple virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Guanfacine-ER

Trial Overview 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.

Participant Groups

Group I: Guanfacine-ER Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a phase 3 safety study of guanfacine extended release (GXR) involving 215 children and adolescents with ADHD, the treatment was well tolerated, with 82.7% experiencing some treatment-emergent adverse events, primarily somnolence and headache.

GXR significantly reduced ADHD symptoms over the 2-year study, with a mean decrease of 19.8 points in the ADHD-RS-IV total score, indicating its efficacy in managing ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Huss, M., Dirks, B., Gu, J., et al.[2018]

In a 9-week study involving 461 children and adolescents with ADHD, guanfacine extended release (GXR) significantly improved ADHD symptoms when added to a stable dose of psychostimulants, outperforming placebo.

GXR treatment did not introduce new safety concerns, with most adverse events being mild to moderate, and showed only small decreases in blood pressure and pulse, indicating it is a safe adjunctive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. Wilens, TE., Bukstein, O., Brams, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of Guanfacine for Cannabis Use Disorder and Related Symptomology. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Guanfacine Attenuates Adverse Effects of Dronabinol (THC) on Working Memory in Adolescent-Onset Heavy Cannabis Users: A Pilot Study. [2018]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A double-blind randomized placebo-controlled study of the efficacy of the combined treatment with naltrexone and guanfacine for relapse prevention in opiate dependence]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Guanfacine decreases symptoms of cannabis withdrawal in daily cannabis smokers. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Guanfacine extended-release for cannabis use disorder: a pilot feasibility trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Pharmacodynamics of Immediate-Release Versus Extended-Release Guanfacine in Adult Daily Smokers. [2020]