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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Christina Ann Brezing, New York State Psychiatric Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cannabis Use Drug: guanfacine-ER Other: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: Guanfacine-ER
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.
 Drug: guanfacine-ER
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.
 Other: Placebo
placebo will be dispensed similar to the active arm.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Christina Brezing, MD 646-774-6132 cb3108@columbia.edu
Contact: Daniel Brooks, LCSW 9178611270 daniel.brooks@nyspi.columbia.edu

Locations
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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      
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Christina Brezing, MD NYSPI
More Information
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Responsible Party: Christina Ann Brezing, Assistant Professor of Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT05273567    
Other Study ID Numbers: 8103
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)
Supporting Materials: Study Protocol
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Ann Brezing, New York State Psychiatric Institute:
cannabis
guanfacine
treatment
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs