A Trial of Guanfacine-er for Cannabis Use Disorder
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|ClinicalTrials.gov Identifier: NCT05273567|
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : June 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use||Drug: guanfacine-ER Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Guanfacine-er for Cannabis Use Disorder|
|Actual Study Start Date :||June 1, 2022|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
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.
guanfacine-er dispensed daily, starting at 1mg and increasing to 4mg/day or the maximum tolerated dose.
Other Name: Intuniv-er
Placebo Comparator: Placebo
Placebo will be taken nightly and titrated and tapered similar to the active arm.
placebo will be dispensed similar to the active arm.
- Change in daily cannabis use as measured by ecological momentary assessments (EMA). [ Time Frame: 12 weeks of study ]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).
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273567
|Contact: Christina Brezing, MDemail@example.com|
|Contact: Daniel Brooks, LCSWfirstname.lastname@example.org|
|United States, New York|
|STARS Clinic at Columbia and NYSPI Department of Psychiatry||Recruiting|
|New York, New York, United States, 10017|
|Contact: Christina Brezing, MD 646-774-8181|
|Principal Investigator:||Christina Brezing, MD||NYSPI|
|Responsible Party:||Christina Ann Brezing, Assistant Professor of Psychiatry, New York State Psychiatric Institute|
|Other Study ID Numbers:||
1K23DA045080-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||March 10, 2022 Key Record Dates|
|Last Update Posted:||June 8, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||beginning twelve months and ending 5 years after article publication|
|Access Criteria:||to researcher who provides a methodologically sound proposal to achieve aims in approved proposal|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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