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ClinicalTrials.gov public records Last synced Oct 2, 2026, 7:32 AM EDT

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Showing 1–24 of 27 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Extended-release Guanfacine Hydrochloride Clear all
Completed Phase 2 Interventional Results available

SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)

NCT01470469
View directory record Official record
Conditions
Generalized Anxiety Disorder (GAD), Anxiety, Separation, Phobia, Social
Interventions
SPD503 (extended-release Guanfacine hydrochloride), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
6 Years to 17 Years
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
33
States / cities
Birmingham, Alabama • Carson, California • Imperial, California + 29 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01244490
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
Extended-release Guanfacine Hydrochloride, Atomoxetine Hydrochloride, Placebo Comparator
Drug
Lead sponsor
Shire
Industry
Eligibility
6 Years to 17 Years
Enrollment
338 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
11
States / cities
San Diego, California • Maitland, Florida • Atlanta, Georgia + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Results available

Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence

NCT01467999
View directory record Official record
Conditions
Cannabis Dependence
Interventions
Guanfacine
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 5, 2019 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

Guanfacine in Children With Tic Disorders

NCT01547000
View directory record Official record
Conditions
Tourette Disorder, Tourette Syndrome
Interventions
placebo, extended-release guanfacine (Intuniv)
Drug
Lead sponsor
Yale University
Other
Eligibility
6 Years to 17 Years
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
3
States / cities
New Haven, Connecticut • Tampa, Florida • New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 13, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional

Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome

NCT05657860
View directory record Official record
Conditions
Prader-Willi Syndrome, Aggression, Self-Injurious Behavior, Pathologic Processes, Behavioral Symptoms, Intellectual Disability, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Abnormalities, Multiple, Congenital Abnormalities, Chromosome Disorders, Genetic Diseases, Inborn, Obesity, Overnutrition, Nutrition Disorders, Antihypertensive Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Skin-Picking
Interventions
Guanfacine Extended Release, Placebo
Drug · Other
Lead sponsor
Maimonides Medical Center
Other
Eligibility
6 Years to 35 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Brooklyn, New York
Source: ClinicalTrials.gov public record
Updated Aug 19, 2024 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With ADHD

NCT01709695
View directory record Official record
Conditions
ADHD, Attention Deficit Hyperactivity Disorder
Interventions
Guanfacine Hydrochloride XR, Placebo
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
8 Years to 15 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 14, 2018 · Synced Oct 2, 2026, 7:32 AM EDT
Withdrawn Phase 4 Interventional

Guanfacine Extended Release and Mindfulness Skills Therapy

NCT03258476
View directory record Official record
Conditions
Stress Disorder
Interventions
Guanfacine Extended Release, Mindfulness Skills Therapy, Placebo
Drug · Behavioral
Lead sponsor
UConn Health
Other
Eligibility
10 Years to 20 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
1
States / cities
Farmington, Connecticut
Source: ClinicalTrials.gov public record
Updated Mar 8, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Combining Varenicline and Guanfacine for Smoking Cessation

NCT04198116
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline, Guanfacine ER
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
167 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2025
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

NCT00997984
View directory record Official record
Conditions
Attention-Deficit/Hyperactivity Disorder
Interventions
extended-release guanfacine hydrochloride (SPD503), placebo, extended-release guanfacine hydrochloride
Drug
Lead sponsor
Shire
Industry
Eligibility
6 Years to 12 Years
Enrollment
340 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
42
States / cities
Little Rock, Arkansas • El Centro, California • Rolling Hills Estates, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)

NCT01069523
View directory record Official record
Conditions
Attention Deficit Disorder With Hyperactivity
Interventions
Guanfacine Extended Release, Placebo
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
6 Years to 12 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Sep 3, 2012 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional

Inuniv and Working Memory

NCT01177306
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
extended release guanfacine
Drug
Lead sponsor
Lori A. Schweickert, MD
Individual
Eligibility
8 Years to 12 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
Cary, North Carolina
Source: ClinicalTrials.gov public record
Updated Jul 28, 2014 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

Interventions for Children With Attention and Reading Disorders

NCT01133847
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder, Reading Disabilities
Interventions
Methylphenidate, Intensive reading instruction, Parent Training, Mixed Salt Amphetamine, Atomoxetine, Guanfacine
Drug · Behavioral
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
7 Years to 12 Years
Enrollment
222 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2015
U.S. locations
2
States / cities
Cincinnati, Ohio • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 11, 2017 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers

NCT00901576
View directory record Official record
Conditions
Healthy
Interventions
SPD503, Concerta, SPD503 + Concerta
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 45 Years
Enrollment
38 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Hackensack, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder

NCT02048241
View directory record Official record
Conditions
Intermittent Explosive Disorder, Childhood Aggression, Oppositional Defiant Disorder, Attention Deficit Disorder
Interventions
Parent Management Training, Placebo, Intuniv
Behavioral · Other · Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
6 Years to 12 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 13, 2018 · Synced Oct 2, 2026, 7:32 AM EDT
Terminated Not applicable Interventional Accepts healthy volunteers Results available

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

NCT02259517
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder
Interventions
Guanfacine, Lisdexamfetamine
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
6 Years to 17 Years
Enrollment
38 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 2, 2023 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of SPD503 in Combination With Psychostimulants

NCT00734578
View directory record Official record
Conditions
ADHD
Interventions
SPD503-AM, SPD503-PM, Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
6 Years to 17 Years
Enrollment
461 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
61
States / cities
Dothan, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 53 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Recruiting Phase 2 Interventional Accepts healthy volunteers

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders

NCT03764098
View directory record Official record
Conditions
Alcohol Use
Interventions
Guanfacine ER, Placebo
Drug · Other
Lead sponsor
Yale University
Other
Eligibility
21 Years to 70 Years
Enrollment
160 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2026
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Feb 27, 2026 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Guanfacine Clinical Trial for Smoking Cessation

NCT02051309
View directory record Official record
Conditions
Smoking Cessation
Interventions
Guanfacine, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 65 Years
Enrollment
121 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2020
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Dec 29, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 4 Interventional Results available

Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

NCT01238575
View directory record Official record
Conditions
Pervasive Development Disorders
Interventions
placebo, extended-release guanfacine
Other · Drug
Lead sponsor
Yale University
Other
Eligibility
5 Years to 14 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
5
States / cities
Los Angeles, California • New Haven, Connecticut • Atlanta, Georgia + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 31, 2020 · Synced Oct 2, 2026, 7:32 AM EDT
Terminated Phase 4 Interventional Results available

Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

NCT01156051
View directory record Official record
Conditions
Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder, Insomnia, Sleep Disorders
Interventions
Guanfacine extended-release tablets, Placebo comparator
Drug
Lead sponsor
Children's Specialized Hospital
Other
Eligibility
6 Years to 12 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
2
States / cities
Hamilton, New Jersey • Toms River, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 11, 2014 · Synced Oct 2, 2026, 7:32 AM EDT
Withdrawn Phase 4 Interventional

Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome

NCT04066088
View directory record Official record
Conditions
Prader-Willi Syndrome
Interventions
Placebo, Guanfacine extended release (GXR)
Other · Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
6 Years to 35 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 26, 2020 · Synced Oct 2, 2026, 7:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

NCT00919867
View directory record Official record
Conditions
Healthy
Interventions
SPD503, VYVANSE, SPD503 and VYVANSE
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 45 Years
Enrollment
42 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Hackensack, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 7:32 AM EDT
Recruiting Phase 4 Interventional

Treating Young Children With Attention Deficit Hyperactivity Disorder

NCT07300956
View directory record Official record
Conditions
Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions
Guanfacine (GUA), Methylphenidate (MPH)
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
3 Years to 5 Years
Enrollment
370 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
5
States / cities
Palo Alto, California • Boston, Massachusetts • Kansas City, Missouri + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2026 · Synced Oct 2, 2026, 7:32 AM EDT
Recruiting Phase 2 Interventional

Guanfacine for Alcohol Use Disorder (AUD)

NCT06629259
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Guanfacine Extended Release (XR), Placebo
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
2
States / cities
Indianapolis, Indiana • Newark, New Jersey
Source: ClinicalTrials.gov public record
Updated May 11, 2026 · Synced Oct 2, 2026, 7:32 AM EDT