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.
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. Due to a federally mandated, institution-wide pause in research activities under our Federal Wide Assurance (FWA) the study and all research was paused on June 23, 2023. Received a interest continuation for participants enrolled when paused and last participant completed on September 8, 2023. NYSPI institutional approval to proceed with research and data analysis was granted on 02/09/2026.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
guanfacine-er dispensed daily, starting at 1mg and increasing to 4mg/day or the maximum tolerated dose.
placebo will be dispensed similar to the active arm.
STARS Clinic at Columbia and NYSPI Department of Psychiatry
New York, New York, United States
Change in Cannabis Use as Measured by Ecological Momentary Assessments (EMA).
Change in quartiles of use 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.
Time frame: 12 weeks of study
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