Cannabis Use
Conditions
Keywords
cannabis, guanfacine, treatment
Brief 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.
Detailed 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. 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.
Interventions
DRUGguanfacine-ER
guanfacine-er dispensed daily, starting at 1mg and increasing to 4mg/day or the maximum tolerated dose.
OTHERPlacebo
placebo will be dispensed similar to the active arm.
Sponsors
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cannabis Use as Measured by Ecological Momentary Assessments (EMA). | 12 weeks of study | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Brezing, MD
NYSPI
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.45 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 10 / 11 | 9 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
None listed