A Trial of Guanfacine-er for Cannabis Use Disorder

NCT05273567 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 81031K23DA045080-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use

Keywords

cannabis; guanfacine; treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Guanfacine-ER

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo will be taken nightly and titrated and tapered similar to the active arm.

Other: Placebo

Interventions

guanfacine-ER DRUG

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

Also known as: Intuniv-er

Guanfacine-ER

Placebo OTHER

placebo will be dispensed similar to the active arm.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

STARS Clinic at Columbia and NYSPI Department of Psychiatry

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christina Brezing, MD

  NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: June 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

US (1)