Clinical Trials

Yohimbine hydrochloride has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, focusing on central nervous system and autonomic disorders such as major depression, post-traumatic stress disorder, orthostatic hypotension, opioid use disorder, and erectile dysfunction. Supported by academic institutions and federal agencies—including the National Institute of Mental Health and the VA Office of Research and Development—these studies have involved both healthy volunteers and specific patient populations. The broader trial landscape encompasses completed, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04231708 NOT_YET_RECRUITING
Opioid Use Disorder
Wayne State University
 2026-10 PHASE2
NCT06430580 COMPLETED
Cannabis Use Disorder
Florida State University
 2024-09-30 EARLY_PHASE1
NCT06939608 COMPLETED
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2025-04-28
NCT07127146 NOT_YET_RECRUITING
Parkinson Disease
Hospices Civils de Lyon
 2025-10-01
NCT06018727 WITHDRAWN
Borderline Personality Disorder
University of North Carolina, Chapel Hill
 2024-07 PHASE4
NCT03154567 COMPLETED
Marijuana Abuse
Wayne State University
 2017-11-01 PHASE1
NCT04346394 WITHDRAWN
Parkinson Disease
Nathaniel M. Robbins
 2021-05-11 EARLY_PHASE1
NCT04180969 WITHDRAWN
Stress; Healthy
Wayne State University
 2023-04-10 PHASE2
NCT04181515 WITHDRAWN
Stress; Opioid-use Disorder
Wayne State University
 2023-04-10 PHASE2
NCT04359147 COMPLETED
Yohimbine; Hydrocortisone; Yohimbine + Hydrocortisone; Placebo
Charite University, Berlin, Germany
 2019-11-01
NCT04346394 Withdrawn
Parkinson Disease
Nathaniel M. Robbins|Dartmouth-Hitchcock Medical Center
 2021-05-11 Early Phase 1
NCT00748059 COMPLETED
Autonomic Nervous System Diseases; Orthostatic Hypotension; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Intolerance
Vanderbilt University Medical Center
 1996-12 PHASE1
NCT04051619 Completed
Opioid Use Disorder
Brown University
 2020-01-06 Phase 1
NCT02963181 TERMINATED
Hypotension, Orthostatic; Hypertension; Autonomic Nervous System Diseases
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2018-03-01 EARLY_PHASE1
NCT03520543 COMPLETED
Healthy Controls
Hospices Civils de Lyon
 2018-05-21 PHASE1
NCT02470026 COMPLETED
Major Depressive Disorder; Early Life Trauma
Charite University, Berlin, Germany
 2014-06
NCT00223691 COMPLETED
Autonomic Failure; Orthostatic Hypotension
Vanderbilt University
 2002-03 PHASE1
NCT03670212 COMPLETED
Cigarette Smoking
Wayne State University
 2016-01-07 PHASE1
NCT01031979 COMPLETED
Post-Traumatic Stress Disorder
VA Office of Research and Development
 2010-12-01 PHASE2
NCT01593215 COMPLETED
Type 2 Diabetes
Anders Rosengren, MD PhD
 2012-05 PHASE2
NCT02541071 COMPLETED
Intrusive Memories
Charite University, Berlin, Germany
 2013-11
NCT01621620 UNKNOWN
Pain
Tel-Aviv Sourasky Medical Center
 2012-08
NCT00958880 COMPLETED
Social Anxiety Disorder
Southern Methodist University
 2009-03 PHASE3
NCT00535002 COMPLETED
Cocaine Related Disorders
Medical University of South Carolina
 2007-09 PHASE2
NCT00605904 COMPLETED
Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2008-01 PHASE2
NCT00975325 COMPLETED
Erectile Dysfunction
Walter Ritter GmbH & Co
 2009-10 PHASE4
NCT00078715 COMPLETED
Depression, Involutional; Major Depresssion
National Institute of Mental Health (NIMH)
 2004-03 PHASE2
NCT00734422 COMPLETED
Phobic Disorders
VU University of Amsterdam
 2008-07 PHASE2; PHASE3
NCT00605904 Completed
Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)|National Institutes of Health Clinical Center (CC)
 2008-01 Phase 2
NCT00217048 COMPLETED
Healthy Volunteers
Mayo Clinic
 2005-06 PHASE1; PHASE2
NCT00000196 Withdrawn
Opioid-Related Disorders
Yale University|National Institute on Drug Abuse (NIDA)
 1993-01 Phase 2
NCT00814047 COMPLETED
Blood Flow Velocity; Autoregulation; Ocular Physiology
Medical University of Vienna
 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-12-30)

Check the Yohimbine HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Yohimbine HCl selectively binds to and antagonizes presynaptic α2-adrenergic receptors, blocking negative feedback loops to increase central and peripheral norepinephrine release. This elevated noradrenergic activity enhances sympathetic outflow and vascular resistance, supporting its clinical investigation for orthostatic hypotension, erectile dysfunction, and stress-related neurological disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.