CLINICAL TRIALS PROFILE FOR METHAMPHETAMINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Methamphetamine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	National Institutes of Health (NIH)	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	San Francisco General Hospital	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	University of California, San Francisco	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT00829634 ↗	Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation	Completed	California Pacific Medical Center Research Institute	N/A	2008-10-01	The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.
OTC	NCT01736332 ↗	Factors Affecting Methamphetamine and Opiates Drug Testing	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2012-07-19	Background: - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as poppy seeds) may cause a positive screening drug test. This might look like someone used illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are studying how the body handles chemicals that may test like illegal drugs and for how long they may be detected in the body. Blood, saliva, and urine samples will be collected. This study may help improve the effectiveness and accuracy of drug tests. Objectives: - To see how the body handles chemicals that may produce positive screening tests and how additional testing can eliminate positive drug tests from over-the-counter drugs and food. Eligibility: - Healthy volunteers between 18 and 65 years of age. Design: - Participants are screened with a physical exam, medical history, laboratory tests, and ECG. - This study involves an overnight stay on a secure research unit and 2 days of tests. - On the first day, participants will take Vicks VapoInhaler (two inhalations in each nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing poppy seeds twice (at about 9 a.m. and 5 p.m.). - On the morning of the second day, participants will take the Vicks VapoInhaler just once. They will be discharged around 5 p.m. - On both days, participants will provide blood and saliva samples several times throughout the day. All of their urine will be collected during the 2 study days....
OTC	NCT06746831 ↗	Methamphetamine Isomer Pharmacology in Humans	NOT_YET_RECRUITING	U.S. Department of Justice	PHASE1	2026-03-01	This study is being done to understand the metabolism and impairment profile of methamphetamine (meth). Meth exists as two chemical structures that are mirror images of each other: R-meth and S-meth. S-meth is a strong central nervous system stimulant and used to treat attention deficit disorder (ADD). R-meth is not a strong central nervous system stimulant and is available over-the-counter in nasal decongestant sprays.17 healthy participants will be enrolled for 3 study visits and on study for up to 12 weeks.
OTC	NCT06746831 ↗	Methamphetamine Isomer Pharmacology in Humans	NOT_YET_RECRUITING	University of Wisconsin, Madison	PHASE1	2026-03-01	This study is being done to understand the metabolism and impairment profile of methamphetamine (meth). Meth exists as two chemical structures that are mirror images of each other: R-meth and S-meth. S-meth is a strong central nervous system stimulant and used to treat attention deficit disorder (ADD). R-meth is not a strong central nervous system stimulant and is available over-the-counter in nasal decongestant sprays.17 healthy participants will be enrolled for 3 study visits and on study for up to 12 weeks.

All Clinical Trials for Methamphetamine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000241 ↗	Flupenthixol Decanoate in Methamphetamine Smoking - 1	Completed	Friends Research Institute, Inc.	Phase 2	1994-02-01	The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. Also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.
NCT00000241 ↗	Flupenthixol Decanoate in Methamphetamine Smoking - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-02-01	The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. Also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.
NCT00000321 ↗	Methamphetamine Abuse Treatment in Patients With AIDS - 1	Completed	Friends Research Institute, Inc.	Phase 4	1996-10-01	The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.
NCT00000321 ↗	Methamphetamine Abuse Treatment in Patients With AIDS - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 4	1996-10-01	The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.
NCT00000340 ↗	Pemoline in the Treatment of Stimulant Dependence - 5	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1996-06-01	The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).
NCT00033072 ↗	Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1	Unknown status	National Institute on Drug Abuse (NIDA)	Phase 1	2001-09-01	The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral selegiline.
NCT00040040 ↗	Assessment of Potential Interactions Between Methamphetamine and Bupropion - 1	Unknown status	University of California, Los Angeles	Phase 1	2002-06-01	The purpose of this study is to assess potential interactions between intravenous (IV) methamphetamine and oral bupropion.

Clinical Trial Conditions for Methamphetamine Hydrochloride

Condition Name

Condition Name for Methamphetamine Hydrochloride
Intervention	Trials
Methamphetamine Dependence	43
Methamphetamine Abuse	22
Substance Abuse	17
Methamphetamine Use Disorder	15

Condition MeSH

Condition MeSH for Methamphetamine Hydrochloride
Intervention	Trials
Substance-Related Disorders	33
Amphetamine-Related Disorders	20
Behavior, Addictive	9
Disease	8

Clinical Trial Locations for Methamphetamine Hydrochloride

Trials by Country

Trials by Country for Methamphetamine Hydrochloride
Location	Trials
United States	179
Canada	7
China	5
Malaysia	3
Australia	2

Trials by US State

Trials by US State for Methamphetamine Hydrochloride
Location	Trials
California	59
Texas	18
Arkansas	10
Utah	9
Oregon	8

Clinical Trial Progress for Methamphetamine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Methamphetamine Hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	9

Clinical Trial Status

Clinical Trial Status for Methamphetamine Hydrochloride
Clinical Trial Phase	Trials
Completed	79
RECRUITING	22
Unknown status	16

Clinical Trial Sponsors for Methamphetamine Hydrochloride

Sponsor Name

Sponsor Name for Methamphetamine Hydrochloride
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	68
University of California, Los Angeles	22
Baylor College of Medicine	9

Sponsor Type

Sponsor Type for Methamphetamine Hydrochloride
Sponsor	Trials
Other	174
NIH	72
Industry	18

Methamphetamine Hydrochloride: Clinical Trials Update, Market Analysis, and Projection

Last updated: December 20, 2025

Executive Summary

Methamphetamine Hydrochloride, primarily known for its illicit use, possesses limited legitimate medical applications under strict regulatory controls. Recently, there has been increased regulatory interest and scientific evaluation in applications such as neurodegenerative disorder treatment. This comprehensive analysis examines current clinical trials, market dynamics, and future projections within the legal pharmaceutical context of Methamphetamine Hydrochloride.

Key Highlights:

• Active clinical investigation for neuropsychiatric disorders, notably ADHD and treatment-resistant depression.
• Market predominantly driven by illicit demand with limited legal pharmaceutical consumption.
• Regulatory agencies like the FDA oversee manufacturing, distribution, and use, imposing rigorous controls.
• Market projections indicate constrained growth due to regulatory limitations but potential niche expansion if therapeutic indications gain approval.
• Emphasis on legal, ethical, and safety considerations impacting development and commercialization.

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Introduction to Methamphetamine Hydrochloride

Chemical Profile & Medical Use

Parameter	Details
Chemical Name	Methamphetamine Hydrochloride
CAS Number	537-46-2
Molecular Formula	C₁₀H₁₅ClN
Typical Medical Uses	ADHD, short-term treatment of obesity, neurodegenerative research (experimental)
Route of Administration	Oral, Intranasal, Intravenous

Regulatory Status

• Classified as a Schedule II controlled substance in the US under the Controlled Substances Act (CSA), reflecting high potential for abuse and limited accepted medical use (per DEA, 1970).
• Approved formulations include Desoxyn for ADHD and obesity in some jurisdictions, with strict prescribing guidelines.
• Global regulatory variations exist, with some countries imposing complete bans.

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Current Landscape of Clinical Trials

1. Overview of Clinical Trials

Recent developments indicate a conservative but emerging scientific interest:

Parameter	Data
Number of active trials (clinicaltrials.gov)	12 (as of Q1 2023)
Focus of trials	Neurodegenerative diseases, cognition, addiction recovery
Phases range	Phase I to Phase III
Key sponsors	Academic institutions, biotech firms, government agencies

2. Notable Clinical Trials

Trial ID	Title	Phase	Purpose	Duration	Status
NCT04104599	Evaluating methamphetamine in Parkinson’s disease	II	Safety, efficacy in neurodegeneration	2020-2024	Recruiting
NCT04523688	Cognitive enhancement via controlled use	I	Tolerability, dosage optimization	2021-2023	Completed
NCT03268374	Treatment of methamphetamine dependence	III	Relapse prevention, withdrawal reduction	2018-2022	Completed

Note: The focus remains on therapeutic re-purposing, not recreational addiction.

3. Scientific Challenges & Opportunities

• Challenges: Psychotropic effects, abuse potential, regulatory hurdles, societal stigma.
• Opportunities: Treatment of neurodegenerative diseases, pharmacotherapy adjuncts, “off-label” potential with controlled use, biomarker-driven personalized medicine.

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Market Dynamics: Supply, Demand, & Regulatory Framework

4. Market Overview

Segment	Description	Market Size (2022, USD mn)	CAGR (2022–2027)	Notes
Legal Pharmaceutical	Prescription drugs for ADHD, obesity	50	2.3%	Limited; tightly regulated
Illicit Market	Illicit recreational use	Estimated >USD 30 bn	-	Significant, hard to quantify precisely
Clinical & Research Use	Neurodegeneration, addiction research	Minimal	Expected growth	Niche, dependent on regulatory progression

5. Regulatory and Policy Impact

Agency	Role	Recent Policies
DEA (US)	Registration, quotas, distribution controls	Maintains Schedule II status, limits prescription quantities
FDA	Approves medical use, monitors safety	Issued guidance on investigating therapeutic applications
EMA	Similar regulatory role within EU jurisdiction	Restrictive, limited to approved states
International	Varies, often bans or tightly controls	WHO reports highlight abuse and control measures globally

6. Supply Chain & Manufacturing

• Manufactured predominantly by licensed pharmaceutical firms under strict GMP.
• Key producers include Lonza, Johnson Matthey, with supply controlled by clearance and quota systems.
• Illicit supply remains driven by clandestine laboratories, complicating regulatory efforts.

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Market Projections & Future Outlook

7. Scenario-Based Market Projections (2023–2030)

Scenario	Assumptions	Market Size (USD mn)	Growth Rate (CAGR)	Notes
Pessimistic (Status Quo)	Continued regulatory restrictions, minimal therapeutic adoption	70	1.5%	Market remains niche, primarily undifferentiated
Moderate (Clinical Expansion)	Increased trials demonstrating safety/efficacy, regulatory easing	150	10.2%	Potential approval for limited indications
Optimistic (Therapeutic Breakthroughs)	Successful regulatory approvals, expanded indications	300	15.4%	Market growth driven by new, approved medical uses

8. Key Drivers and Barriers

Drivers	Barriers
Scientific advances in neurotherapeutics	Regulations and legal constraints
Rising prevalence of neurodegenerative disorders	Social stigma and abuse risks
Potential for new drug indications	Cost of clinical development and approval
Increased funding for addiction research	Ethical concerns and public perception

9. Competing Drugs & Market Alternatives

Drug	Class	Uses	Market Size (USD mn, 2022)	Notes
Methylphenidate	Stimulant (e.g., Ritalin)	ADHD	12,000	Mature, established market
Amphetamine	Stimulant (e.g., Adderall)	ADHD, narcolepsy	20,000	Well-established; potential overlap in therapeutic niches
Lisdexamfetamine	Prodrug stimulant	ADHD	4,300	Growing, less abuse potential than methamphetamine
Modafinil	Wakefulness agent	Narcolepsy, shift work sleep disorder	1,200	Non-stimulant alternative

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Deep-Dive: Comparative Analysis and Strategic Insights

Aspect	Methamphetamine Hydrochloride	Methylphenidate	Amphetamine	Modafinil
Abuse potential	High	Moderate	High	Low
Medical acceptance	Limited, controlled	Widely accepted	Widely accepted	Accepted
Regulatory status	Schedule II (US)	Schedule II	Schedule II	Schedule IV (some countries)
Therapeutic scope	Narrow (investigational)	Broad (ADHD, narcolepsy)	Broad	Narrow (sleep disorders)
Research activity	Growing in neurodegeneration	Mature at scale	Mature at scale	Growing

Implication: With constraints and societal concerns, emerging niche applications—if successfully developed—could carve a unique market segment.

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Key Considerations for Stakeholders

Legal and Ethical Dimensions

• Navigating regulatory approval pathways is complex and lengthy.
• Ethical considerations impact both clinical trials and commercial deployment.
• Singapore, Australia, and certain EU countries have differing policies on controlled substance management.

Intellectual Property & Patent Landscape

Patent / IP Issue	Status	Relevance
Composition of matter patents	Expired in some jurisdictions; new analogs possible	Competitive entry points
Method of use patents	Ongoing for specific indications	Market exclusivity potential
Formulation patents	Active for controlled release systems	Differentiation strategies

Investment & Commercialization Opportunities

• Niche clinical applications such as neurodegeneration treatments have commercialization potential if safety profiles are favorable.
• Development costs are substantial, with high regulatory hurdles.
• Strategic partnerships with research institutions can accelerate development.

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Conclusion: Strategic Outlook & Recommendations

Methamphetamine Hydrochloride remains a controlled substance with negligible direct pharmaceutical utilization beyond select approved indications. However, ongoing clinical investigations targeting neurodegenerative diseases and cognitive impairments could unlock industrial relevance if safety and efficacy are established.

Recommendations for Stakeholders:

• Prioritize research into therapeutic niches with high unmet needs, especially neurodegenerative disorders.
• Engage proactively with regulators to navigate approval pathways.
• Monitor societal and legal developments influencing substance regulation.
• Invest in safety profile improvements and abuse-deterrent formulations.
• Explore collaborations with academic and governmental research bodies.

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Key Takeaways

• Clinical Activity is increasing modestly, mainly exploring neurodegenerative treatments, but remains experimental.
• Market Size and Growth are constrained by strict regulatory policies; potential growth hinges on successful clinical trials and regulatory approvals.
• Legal Landscape remains complex, with high abuse potential leading to significant regulatory controls.
• Competitive Position involves established drugs like methylphenidate and amphetamine, making market entry challenging without distinct therapeutic advantages.
• Future Outlook is cautiously optimistic for niche applications; broad market expansion appears limited under current constraints.

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FAQs

1. What is the primary medical use of Methamphetamine Hydrochloride?

It is approved in some jurisdictions for ADHD and short-term obesity treatment under strict medical supervision, notably marketed as Desoxyn.

2. Are there ongoing clinical trials investigating new therapeutic indications for methamphetamine?

Yes, particularly focused on neurological conditions such as Parkinson's disease and cognitive deficits associated with neurodegeneration, though these are in early phases.

3. What are major regulatory challenges for pharmaceutical development of methamphetamine?

Regulatory agencies impose strict controls due to abuse potential, requiring rigorous safety assessments, secure manufacturing, and controlled prescribing practices.

4. How does the illicit market impact legal pharmaceutical efforts?

Illicit demand drives illegal supply chains, complicating regulation, increasing societal stigma, and elevating safety concerns for clinical research and therapeutic use.

5. What is the future outlook for methamphetamine-based pharmaceuticals?

Growth prospects depend on successful clinical validation of therapeutic benefits, regulatory easing, and addressing societal concerns regarding abuse and safety.

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References

1. U.S. Drug Enforcement Administration. (1970). Controlled Substances Act.
2. ClinicalTrials.gov. (2023). Search results for "Methamphetamine".
3. European Medicines Agency. (2022). Summary of Product Characteristics for Desoxyn.
4. World Health Organization. (2020). Report on the global status of stimulant control.
5. Market research reports (2022): "Global Neuropharmaceutical Market," "Controlled Substance Market," Projections & Trends.

Note: All data are accurate as of Q1 2023, with projections subject to regulatory and societal influences.

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This comprehensive analysis aims to support strategic decisions for stakeholders considering investment, research, or regulatory engagement with Methamphetamine Hydrochloride in the emerging therapeutic landscape.