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Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR NALTREXONE HYDROCHLORIDE


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All Clinical Trials for Naltrexone Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000195 ↗ Neurobiology of Opioid Dependence: 4 - 4 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.
NCT00000195 ↗ Neurobiology of Opioid Dependence: 4 - 4 Withdrawn Yale University Phase 2 1993-01-01 The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.
NCT00000196 ↗ Neurobiology of Opioid Dependence: 5 - 5 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.
NCT00000196 ↗ Neurobiology of Opioid Dependence: 5 - 5 Withdrawn Yale University Phase 2 1993-01-01 The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.
NCT00000230 ↗ Buprenorphine Detoxification With Two Types of Treatment. BBD III - 12 Completed National Institute on Drug Abuse (NIDA) Phase 2 1995-01-01 The purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with naltrexone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Naltrexone Hydrochloride

Condition Name

Condition Name for Naltrexone Hydrochloride
Intervention Trials
Alcoholism 55
Alcohol Dependence 50
Obesity 28
Opioid Dependence 20
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Condition MeSH

Condition MeSH for Naltrexone Hydrochloride
Intervention Trials
Alcoholism 124
Opioid-Related Disorders 97
Disease 50
Substance-Related Disorders 33
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Clinical Trial Locations for Naltrexone Hydrochloride

Trials by Country

Trials by Country for Naltrexone Hydrochloride
Location Trials
United States 816
Canada 15
Germany 13
China 12
Russian Federation 11
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Trials by US State

Trials by US State for Naltrexone Hydrochloride
Location Trials
New York 69
Connecticut 58
California 54
Pennsylvania 53
Texas 38
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Clinical Trial Progress for Naltrexone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Naltrexone Hydrochloride
Clinical Trial Phase Trials
Phase 4 104
Phase 3 62
Phase 2/Phase 3 36
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Clinical Trial Status

Clinical Trial Status for Naltrexone Hydrochloride
Clinical Trial Phase Trials
Completed 303
Recruiting 58
Not yet recruiting 47
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Clinical Trial Sponsors for Naltrexone Hydrochloride

Sponsor Name

Sponsor Name for Naltrexone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 96
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 61
Yale University 39
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Sponsor Type

Sponsor Type for Naltrexone Hydrochloride
Sponsor Trials
Other 523
NIH 180
Industry 133
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Naltrexone Hydrochloride: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Naltrexone hydrochloride, a medication initially developed to treat opioid and alcohol addiction, is now being explored for its potential in treating a variety of other conditions, including Long COVID and Myalgic Encephalomyelitis (ME). This article delves into the current clinical trials, market analysis, and future projections for naltrexone hydrochloride.

Clinical Trials: Exploring New Uses for Naltrexone Hydrochloride

Trials for Long COVID and ME

Clinical trials in Australia and other countries are investigating the efficacy of low-dose naltrexone (LDN) in alleviating symptoms of Long COVID and ME. The Australian trial, conducted by scientists from Griffith University’s National Centre for Neuroimmunology and Emerging Diseases (NCNED), involves 100 patients with Long COVID, with 50 receiving LDN and the other 50 a placebo. The study tracks multiple symptoms over three months, including cognitive function, pain, sleep, and fatigue, among others[1].

Mechanism of Action

Research has shown that LDN can "unlock" faulty calcium ion channels in immune cells, which is crucial for patients with ME and Long COVID. This discovery has prompted further clinical trials to formalize the decades of patient experiences with LDN[1].

Other Ongoing Trials

In addition to the Australian trial, other randomized controlled trials (RCTs) are underway. For example, a Canadian RCT is examining whether LDN can reduce fatigue in Long COVID patients with ME/CFS-like symptoms. Another study at Harvard University is investigating the response of ME/CFS patients to LDN and/or Mestinon, a drug used to treat myasthenia gravis[1].

Market Analysis: Current Trends and Drivers

Market Size and Growth

The global naltrexone hydrochloride market was valued at USD 1.5 billion in 2023 and is projected to reach USD 2.59 billion by 2031, growing at a compound annual growth rate (CAGR) of 7% from 2024 to 2031. This growth is driven by increasing awareness and treatment of alcohol and opioid addiction, as well as government initiatives and improvements in pharmaceutical formulations[2].

Market Segmentation

The market is segmented based on type (oral, injectable, implant), application (alcohol dependence treatment, opioid dependence treatment, opioid overdose reversal, others), and geographical regions. The demand for naltrexone hydrochloride is rising due to the growing prevalence of substance addiction and the need for effective treatment alternatives[2].

Key Drivers

  • Government Support: Strong government financing and legislative efforts for addiction treatment programs are significant drivers.
  • Public Awareness: Increased public knowledge of treatment options for alcoholism and opioid addiction.
  • Pharmaceutical Advancements: Improvements in medication composition, such as extended-release versions, enhance treatment outcomes and patient adherence.
  • Healthcare Infrastructure: Growing healthcare infrastructure in developing nations supports market expansion[2][3].

Market Projections: Future Outlook

Expanding Therapeutic Uses

The naltrexone market is expected to grow significantly due to the continuous development of new therapeutic uses. The drug's ability to modulate the immune system and reduce inflammation makes it a potential treatment for autoimmune diseases, which are on the rise. According to the National Health Council, autoimmune conditions are affecting over 50 million Americans, with certain studies anticipating a 3-12% annual increase in incidence[3].

Market Growth Predictions

By 2034, the global naltrexone market is projected to reach USD 30.8 billion, growing at a CAGR of 3.6% from 2024 to 2034. This growth is fueled by the increasing incidence of autoimmune diseases and the rising number of people addicted to alcohol and opioids[3].

Challenges and Considerations

Evidence Base

Despite its versatile use, the evidence base for LDN in treating conditions outside its licensed scope remains patchy. Few clinical trials have formally tested its efficacy, leading to cautious optimism among patients and researchers[1].

Regulatory and Safety Aspects

Naltrexone hydrochloride has a strong safety profile, but its use in new indications requires rigorous clinical trials to establish efficacy and safety. The drug undergoes significant first-pass metabolism, and its oral bioavailability varies widely, which can affect its therapeutic efficacy[4].

Key Takeaways

  • Clinical Trials: Ongoing trials are exploring the use of LDN for Long COVID and ME, building on patient experiences and preliminary research.
  • Market Growth: The naltrexone hydrochloride market is expected to grow significantly due to increasing awareness of addiction treatments and the development of new therapeutic uses.
  • Drivers: Government support, public awareness, pharmaceutical advancements, and growing healthcare infrastructure are key drivers of market growth.
  • Challenges: The need for robust clinical trials to establish the efficacy and safety of LDN in new indications remains a significant challenge.

FAQs

What is the primary use of naltrexone hydrochloride?

Naltrexone hydrochloride is primarily used to treat opioid and alcohol addiction by acting as an opioid receptor antagonist.

What are the new potential uses of low-dose naltrexone (LDN)?

LDN is being explored for its potential in treating Long COVID, Myalgic Encephalomyelitis (ME), chronic pain, multiple sclerosis, and other autoimmune and inflammatory diseases.

What is the current market size of the naltrexone hydrochloride market?

The global naltrexone hydrochloride market was valued at USD 1.5 billion in 2023.

What is the projected growth rate of the naltrexone hydrochloride market?

The market is expected to grow at a CAGR of 7% from 2024 to 2031, reaching USD 2.59 billion by 2031.

What are the key drivers of the naltrexone hydrochloride market growth?

Key drivers include government support for addiction treatment, public awareness, pharmaceutical advancements, and growing healthcare infrastructure in developing nations.

Sources

  1. The Sick Times: "Clinical trials explore how Low-Dose Naltrexone could help people with Long COVID"[1]
  2. Market Research Intellect: "Naltrexone Hydrochloride Market Size and Projections"[2]
  3. Transparency Market Research: "Naltrexone Market Size, Share and Growth Report, 2034"[3]
  4. DrugBank: "Naltrexone: Uses, Interactions, Mechanism of Action"[4]

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