CLINICAL TRIALS PROFILE FOR DOLOPHINE HYDROCHLORIDE

All Clinical Trials for Dolophine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00149630 ↗	Pharmacogenetics of Disulfiram for Cocaine	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2005-01-01	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00149630 ↗	Pharmacogenetics of Disulfiram for Cocaine	Completed	Yale University	Phase 2	2005-01-01	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00149630 ↗	Pharmacogenetics of Disulfiram for Cocaine	Completed	Baylor College of Medicine	Phase 2	2005-01-01	Previous research has shown that disulfiram, a medication sometimes used for treating alcoholism, discourages cocaine use among cocaine addicts who are undergoing methadone treatment. By blocking the enzyme dopamine beta hydroxylase (DBH), disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users. This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH.
NCT00726830 ↗	Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer	Terminated	National Cancer Institute (NCI)	N/A	2009-03-01	RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.
NCT00726830 ↗	Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer	Terminated	M.D. Anderson Cancer Center	N/A	2009-03-01	RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.

Clinical Trial Conditions for Dolophine Hydrochloride

Condition Name

Condition Name for Dolophine Hydrochloride
Intervention	Trials
Pain	2
Postoperative Pain	1
Brain and Central Nervous System Tumors	1
Lymphoproliferative Disorder	1

Condition MeSH

Condition MeSH for Dolophine Hydrochloride
Intervention	Trials
Pain, Postoperative	4
Opioid-Related Disorders	2
Syndrome	2
Head and Neck Neoplasms	1

Clinical Trial Locations for Dolophine Hydrochloride

Trials by Country

Trials by Country for Dolophine Hydrochloride
Location	Trials
United States	12

Trials by US State

Trials by US State for Dolophine Hydrochloride
Location	Trials
New York	3
Illinois	2
Texas	2
Missouri	1
California	1

Clinical Trial Progress for Dolophine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dolophine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Dolophine Hydrochloride
Clinical Trial Phase	Trials
Completed	7
Withdrawn	2
Enrolling by invitation	1

Clinical Trial Sponsors for Dolophine Hydrochloride

Sponsor Name

Sponsor Name for Dolophine Hydrochloride
Sponsor	Trials
State University of New York at Buffalo	2
Northwestern University	2
National Institute on Drug Abuse (NIDA)	2

Sponsor Type

Sponsor Type for Dolophine Hydrochloride
Sponsor	Trials
Other	16
NIH	5

DOLOPHINE HYDROCHLORIDE: Clinical Trials, Market Analysis, and Projections

Introduction

DOLOPHINE HYDROCHLORIDE, commonly known as methadone hydrochloride, is a synthetic opioid used primarily for the management of severe pain and the treatment of opioid addiction. This article delves into the clinical trials, market analysis, and future projections for this crucial medication.

Clinical Trials and Efficacy

Treatment of Opioid Addiction

Clinical trials have extensively evaluated the efficacy of methadone hydrochloride in the treatment of opioid addiction. A notable study compared moderate- vs high-dose methadone in outpatient treatment, showing that both doses were effective in reducing opioid-positive urine samples over time. However, the high-dose group demonstrated a continued decline in opioid-positive test results beyond the initial weeks of treatment, suggesting a potential benefit of higher doses in maintaining long-term treatment efficacy[4].

Pain Management

Methadone hydrochloride is also indicated for the management of severe pain that requires daily, around-the-clock, long-term opioid treatment. Clinical studies emphasize the importance of slow titration due to the high variability in the pharmacokinetic profile of methadone, which can lead to significant differences in the time required to achieve stable doses[1].

Market Analysis

Current Market Size

The global methadone hydrochloride market has shown significant growth in recent years. As of 2024, the market size was estimated to be around $67 million[2] and $172.86 million[3], depending on the source and specific market segmentation.

Growth Projections

The market is projected to grow substantially over the next several years. By 2030, the market is expected to reach $89 million, growing at a Compound Annual Growth Rate (CAGR) of 4.8%[2]. More extended projections suggest that the market could exceed $437.27 million by 2037, with a CAGR of 7.4% from 2025 to 2037[3].

Regional Market Share

Geographically, North America and Europe hold a significant share of the methadone hydrochloride market. However, the Asia Pacific and other regions are expected to witness substantial growth in the coming years due to increasing awareness and favorable government policies[5].

Market Trends and Drivers

Growing Prevalence of Opioid Addiction

The rising prevalence of opioid addiction is a major driver of the methadone hydrochloride market. Increasing awareness and acceptance of methadone as a treatment option, along with favorable government policies to combat the opioid crisis, are contributing to market growth[5].

Advances in Formulation and Technology

Advances in formulation, such as extended-release formulations, are enhancing patient outcomes and compliance. Research on combination therapies with other drugs is also aimed at reducing side effects and improving treatment efficacy[5].

Increasing Geriatric Population

The growing geriatric population suffering from chronic diseases is another factor driving the market. Methadone oral solutions, which are easier to consume for patients with difficulty swallowing tablets, are anticipated to account for a significant market share in the forecast period[3].

Challenges and Regulatory Considerations

Stringent Regulations

Methadone hydrochloride is subject to stringent regulations due to its potential for misuse. These regulations govern its prescription and distribution, which can impact market dynamics and industry growth. Regulatory changes can also affect the market size and growth rate[5].

Potential Side Effects

The potential side effects associated with methadone hydrochloride, such as CNS and respiratory depression, are a significant concern. These side effects necessitate close monitoring of patients and can hinder market growth to some extent[1].

Key Market Players

Major players in the methadone hydrochloride market include Roxane Laboratories, Mallinckrodt, Siegfried Ltd, MACFARLAN SMITH, and Tianjin Central Pharma. Other notable companies such as Eli Lilly and Sanofi are also involved in the market[2][5].

End User Concentration

The primary end users of methadone hydrochloride are individuals seeking treatment for opioid addiction and pain management. Hospitals, clinics, and rehabilitation centers account for a significant portion of the demand for this medication[5].

Conclusion

DOLOPHINE HYDROCHLORIDE is a critical medication in the treatment of opioid addiction and severe pain. Clinical trials have demonstrated its efficacy, and market projections indicate significant growth driven by increasing prevalence of opioid addiction, advances in formulation, and favorable government policies. However, the market must navigate stringent regulations and potential side effects to continue its growth trajectory.

Key Takeaways

• Clinical Efficacy: Methadone hydrochloride is effective in treating opioid addiction and managing severe pain, with clinical trials supporting its use in both moderate and high doses.
• Market Growth: The global methadone hydrochloride market is projected to grow significantly, with a CAGR of 4.8% to 7.4% over the next several years.
• Regional Trends: North America and Europe currently dominate the market, but the Asia Pacific and other regions are expected to see substantial growth.
• Regulatory Considerations: Stringent regulations and potential side effects are key challenges that the market must address.
• Market Drivers: Growing prevalence of opioid addiction, advances in formulation, and favorable government policies are driving market growth.

FAQs

What is DOLOPHINE HYDROCHLORIDE used for?

DOLOPHINE HYDROCHLORIDE, or methadone hydrochloride, is used for the management of severe pain and the treatment of opioid addiction, including detoxification and maintenance treatment.

What are the key drivers of the methadone hydrochloride market?

The key drivers include the growing prevalence of opioid addiction, advances in formulation and technology, and favorable government policies to combat the opioid crisis.

What are the potential side effects of methadone hydrochloride?

Potential side effects include CNS and respiratory depression, which require close monitoring of patients.

Who are the major players in the methadone hydrochloride market?

Major players include Roxane Laboratories, Mallinckrodt, Siegfried Ltd, MACFARLAN SMITH, and Tianjin Central Pharma.

What is the projected market size of methadone hydrochloride by 2030?

The market is projected to reach $89 million by 2030, growing at a CAGR of 4.8% from 2024 to 2030[2].

Sources

1. Boehringer Ingelheim. Dolophine Tablets.pdf.
2. Valuates Reports. Global Methadone Hydrochloride Market Insights, Forecast to 2030.
3. Research Nester. Methadone Market Size, Trends | Growth Analysis - 2037.
4. JAMA Network. Moderate- vs High-Dose Methadone in the Treatment of Opioid Dependence.
5. Data Insights Market. Decoding Methadone Hydrochloride's Market Size Potential by 2033.