A Trial of Guanfacine-er for Cannabis Use Disorder

Cannabis Use Clinical Trial

Official title:

A Randomized Controlled Trial of Guanfacine-er for Cannabis Use Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05273567
• Other study ID #: 8103
• Secondary ID: 1K23DA045080-01A
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to investigate the effect of guanfacine-ER on reductions in cannabis use and explore its effects on impulsivity and withdrawal through a hybrid in-person and virtual trial of treatment-seeking individuals with Cannabis Use Disorder (CUD), and assessing the feasibility of the virtual components of the study.

Description:

This will be a 12-week randomized, double-blind, placebo-controlled trial, of guanfacine-ER compared to placebo for CUD. 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 or maximum dose as tolerated through week 4. Patients will be maintained on the medication through week 11. During week 11, they will begin a taper to discontinuation, decreasing the dose of guanfacine by 1mg every 4 days until stopped during the last week of the study (week 12). The primary purpose of this study is therefore to investigate the effect of guanfacine-ER on reductions in cannabis use and explore its effects on impulsivity and withdrawal through a hybrid in person and virtual trial of treatment-seeking individuals with CUD. In light of COVID-19 viral transmission mitigation policies, we will make use of the technological applications of virtual visits, remote administration of urine drug testing and medication, and ecological momentary assessments (EMA) in conjunction with once monthly in person visits to the clinic during weeks 1, 4, 8, 12.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Meets DSM-V criteria for a current cannabis use disorder

• Seeking treatment for cannabis use disorder with goal to reduce or stop use

• THC-positive drug screen

• Capable of giving informed consent and complying with study procedures

• Access to internet and devices capable of completing study procedures

• capability of receiving mailed packages for study supplies

Exclusion Criteria:

• Lifetime history of DSM-V diagnosis of schizophrenia or schizoaffective disorder

• Current DSM-V criteria for a psychiatric disorder supported by the MINI that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on psychotropic medication for at least 2 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (guanfacine-ER). Any medical or psychiatric conditions that in the investigator's judgment would interfere with safe participation in the study will be exclusionary.

• Individuals who meet DSM-V criteria for any moderate to severe substance use disorder other cannabis, caffeine or nicotine use disorders

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

• Legally mandated to participate in a substance use disorder treatment program

• Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide

• Known history of allergy, intolerance, or hypersensitivity to guanfacine

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

• Individuals currently being treated with the antihypertensive medications, including the class of alpha 2 agonists that have a potential drug-interaction with guanfacine based on adrenergic modulation

• Individuals currently taking medications that may interact adversely with guanfacine and deemed not clinically safe by study physician at consent, such as rifampicin, ketoconazole, St. John's Wort, and amitriptyline.

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana Abuse

Intervention

Drug:
• guanfacine-ER
guanfacine-er dispensed daily, starting at 1mg and increasing to 4mg/day or the maximum tolerated dose.

Other:
• Placebo
placebo will be dispensed similar to the active arm.

Locations

Country	Name	City	State
United States	STARS Clinic at Columbia and NYSPI Department of Psychiatry	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily cannabis use as measured by ecological momentary assessments (EMA).	Change in number of days of use per week as compared to baseline. Participants will complete ecological momentary assessments (EMA) daily on any internet-accessible device (smart phone, computer, tablet). The daily EMA will assess cannabis use during quartiles of the day. Participants will mark "Yes" if they used cannabis from 12AM-6AM, 6AM-12PM, 12PM-6PM, or 6PM-12AM for each 24 hour period of the study. Primary Outcome will dichotomize each day as a use day (1) or a non using day (0).	12 weeks of study