Clinical Trials

Multiple clinical trials have evaluated the therapeutic potential of nefazodone hydrochloride across psychiatric and substance use disorders, primarily focusing on cocaine-related conditions, general substance abuse, marijuana dependence, and social anxiety disorder. Ranging from Phase 2 to Phase 4, these completed studies were sponsored by organizations such as Boston Medical Center, Emory University, and the National Institute on Drug Abuse. Overall, these investigations explored the compound's pharmacological impact on substance dependence, relapse intervention, and neuroendocrine responses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00249509 COMPLETED
Marijuana Abuse
National Institute on Drug Abuse (NIDA)
 2000-09 PHASE2
NCT00015210 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
Boston Medical Center
 1997-02 PHASE2
NCT00231348 COMPLETED
Social Anxiety Disorder (SAD)
Emory University
 PHASE4
NCT00000286 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 1996-12 PHASE2
NCT00000293 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 1999-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2017-01-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nefazodone hydrochloride acts as an atypical antidepressant by antagonizing serotonin receptors and inhibiting presynaptic serotonin reuptake, which attenuates serotonergic downstream signal transduction to modulate central monoaminergic activity. This attenuation of central serotonin pathway signaling alters reward processing and emotional circuitry, supporting its clinical investigation for treating social anxiety disorder and substance-related conditions such as cocaine and marijuana abuse.

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.