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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Baclofen Clear all
Completed Phase 3 Interventional Results available

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

NCT00516503
View directory record Official record
Conditions
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Interventions
baclofen/amitriptyline/ketamine gel, placebo
Drug · Other
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older
Enrollment
208 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
165
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Aurora, Illinois + 104 more
Source: ClinicalTrials.gov public record
Updated Aug 23, 2017 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional

Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

NCT00000303
View directory record Official record
Conditions
Cocaine-Related Disorders
Interventions
Baclofen
Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1997
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jul 10, 2016 · Synced Sep 25, 2026, 4:48 AM EDT
Terminated Phase 1 Interventional

Botox vs. Baclofen for Upper Limb Spasticity

NCT00280280
View directory record Official record
Conditions
Spasticity
Interventions
intramuscular Botox versus oral baclofen
Drug
Lead sponsor
Vanderbilt University
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 19, 2012 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional

Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine

NCT00218166
View directory record Official record
Conditions
Cocaine-Related Disorders
Interventions
GABA Agonists
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 50 Years
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2005
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Jan 10, 2017 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional Results available

A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

NCT01076283
View directory record Official record
Conditions
Alcoholism
Interventions
Baclofen, Cyproheptadine
Drug
Lead sponsor
Brown University
Other
Eligibility
21 Years to 65 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Oct 16, 2013 · Synced Sep 25, 2026, 4:48 AM EDT
Terminated Phase 2 Interventional Results available

Baclofen Effects on Smoking Urge and Withdrawal

NCT00257894
View directory record Official record
Conditions
Nicotine Use Disorder, Nicotine Dependence, Smoking, Tobacco Use Disorder
Interventions
Baclofen, Placebo
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years to 65 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2008
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Nov 3, 2015 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Baclofen for Treating Anxiety and Alcoholism

NCT01751386
View directory record Official record
Conditions
Alcoholism, Alcohol Dependence, Alcohol Drinking Related Problems, Alcohol Drinking, Anxiety Disorder
Interventions
Baclofen, Placebo
Drug · Other
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Eligibility
21 Years to 65 Years
Enrollment
39 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2016
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 17, 2017 · Synced Sep 25, 2026, 4:48 AM EDT
Withdrawn Phase 2 Interventional

A Study of Baclofen ER

NCT02003664
View directory record Official record
Conditions
Cocaine Dependence
Interventions
Baclofen ER, Placebo
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 60 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 7, 2016 · Synced Sep 25, 2026, 4:48 AM EDT
Terminated Phase 2 Interventional Results available

Preventing Alcohol Withdrawal With Oral Baclofen

NCT01937364
View directory record Official record
Conditions
Alcoholism, Alcohol Withdrawal
Interventions
Baclofen, Placebo
Drug
Lead sponsor
Essentia Health
Other
Eligibility
21 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
2
States / cities
Duluth, Minnesota • Fargo, North Dakota
Source: ClinicalTrials.gov public record
Updated May 4, 2017 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

NCT05257447
View directory record Official record
Conditions
Pharmacokinetics
Interventions
Baclofen 20 mg Tablet, Chlorzoxazone 500 mg Tablet, Baclofen 20mg tablet and Chlorzoxazone 500 mg tablet
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 55 Years
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 30, 2023 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional

Baclofen for the Treatment of Cocaine Dependence - 1

NCT00082485
View directory record Official record
Conditions
Cocaine-Related Disorders
Interventions
Baclofen, Placebo
Drug · Other
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 99 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
8
States / cities
San Francisco, California • Torrance, California • Denver, Colorado + 5 more
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Sep 25, 2026, 4:48 AM EDT
Terminated Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

NCT04251819
View directory record Official record
Conditions
Acute Pain, Analgesia
Interventions
Placebos, Baclofen 5 mg, Baclofen 10mg
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2024
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jan 6, 2026 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional

Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

NCT01288716
View directory record Official record
Conditions
Autism Spectrum Disorders
Interventions
Arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
5 Years to 21 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
24
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2013 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS

NCT03319732
View directory record Official record
Conditions
Multiple Sclerosis, Spasticity, Muscle
Interventions
Arbaclofen
Drug
Lead sponsor
RVL Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
323 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Fresno, California
Source: ClinicalTrials.gov public record
Updated Aug 8, 2022 · Synced Sep 25, 2026, 4:48 AM EDT
Not listed Early Phase 1 Interventional

Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

NCT06274021
View directory record Official record
Conditions
Spinal Cord Injuries, Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
Interventions
Transcutaneous spinal stimulation at 100 Hz, Transcutaneous spinal stimulation at 50 Hz, Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen, Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine, Sham transcutaneous spinal stimulation
Device · Combination Product
Lead sponsor
University of Mississippi Medical Center
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
2
States / cities
Jackson, Mississippi
Source: ClinicalTrials.gov public record
Updated Jun 30, 2024 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers

Baclofen for Children With Rumination Syndrome

NCT05975684
View directory record Official record
Conditions
Rumination Syndrome
Interventions
Baclofen, Placebo
Drug
Lead sponsor
Nationwide Children's Hospital
Other
Eligibility
4 Years to 18 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2025
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Mar 5, 2026 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Early Phase 1 Interventional Results available

Neurophysiological and Acute Pharmacological Studies in FXS Patients

NCT02998151
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Acamprosate, Lovastatin, Minocycline, Placebo, Baclofen
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
15 Years to 55 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 25, 2021 · Synced Sep 25, 2026, 4:48 AM EDT
Not listed Not applicable Interventional Accepts healthy volunteers

Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)

NCT04530955
View directory record Official record
Conditions
Injuries, Spinal Cord, CVA (Cerebrovascular Accident), Traumatic Brain Injury, MS (Multiple Sclerosis), Muscle Spasticity, Cerebral Palsy, Spastic
Interventions
Prometra II Programmable Pump - Flowonix Medical
Device
Lead sponsor
Culicchia Neurological Clinic
Other
Eligibility
22 Years to 85 Years
Enrollment
92 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
1
States / cities
Marrero, Louisiana
Source: ClinicalTrials.gov public record
Updated Sep 27, 2020 · Synced Sep 25, 2026, 4:48 AM EDT
Active, not recruiting Phase 2 Interventional

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

NCT05418049
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Baclofen, Memantine, Roflumilast, Placebo
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
18 Years to 45 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 4 Interventional Results available

SISTERS: Spasticity In Stroke Study - Randomized Study

NCT01032239
View directory record Official record
Conditions
Severe Spasticity
Interventions
intrathecal baclofen
Drug
Lead sponsor
MedtronicNeuro
Industry
Eligibility
18 Years to 75 Years
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2016
U.S. locations
9
States / cities
Irvine, California • Washington D.C., District of Columbia • Doral, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2018 · Synced Sep 25, 2026, 4:48 AM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers

NCT01172509
View directory record Official record
Conditions
Autism
Interventions
R-baclofen
Drug
Lead sponsor
Gonzalez-Heydrich, Joseph, M.D.
Individual
Eligibility
18 Years to 30 Years
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2012
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 20, 2015 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Not applicable Interventional

Effects of Flourish HEC on Localized Provoked Vulvodynia

NCT05478746
View directory record Official record
Conditions
Vulvodynia, Vestibulodynia, Vulvar Diseases, Vulvar Vestibulitis, Vulvar Pain
Interventions
BioNourish, a component of the Flourish HEC kit, Control - no intervention
Device · Other
Lead sponsor
Vaginal Biome Science
Other
Eligibility
18 Years to 52 Years · Female only
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Virginia Beach, Virginia
Source: ClinicalTrials.gov public record
Updated Feb 5, 2024 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Not applicable Interventional

Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder

NCT00320047
View directory record Official record
Conditions
Eating Disorders, Bulimia Nervosa
Interventions
Baclofen
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 55 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 11, 2013 · Synced Sep 25, 2026, 4:48 AM EDT
Completed Phase 2 Interventional Results available

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

NCT01980706
View directory record Official record
Conditions
Alcoholism
Interventions
Baclofen, Placebo
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 65 Years
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 11, 2019 · Synced Sep 25, 2026, 4:48 AM EDT