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.

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.

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

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

Last updated: October 31, 2025

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Introduction

Methamphetamine hydrochloride, a potent central nervous system (CNS) stimulant, has garnered significant attention due to its dual roles: as a well-established illicit substance with high abuse potential, and as a legally controlled pharmaceutical under specific medical conditions. While traditionally used recreationally, recent scientific developments and regulatory shifts have prompted renewed interest in its clinical applications, particularly in neurodegenerative and psychiatric disorders. This article provides a comprehensive analysis of the latest clinical trials, market dynamics, and future projections concerning methamphetamine hydrochloride.

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Clinical Trials Update

Current Clinical Landscape

Officially, methamphetamine hydrochloride’s approved medical uses include the treatment of attention deficit hyperactivity disorder (ADHD) and exogenous obesity under strict regulatory oversight (e.g., FDA’s Schedule II classification). These known applications are supported by validated clinical data, emphasizing its efficacy in controlled settings.

However, emerging research leverages advances in neuropharmacology to explore novel applications:

• Neurodegenerative Disorders: Several trials are investigating methamphetamine’s potential to modulate dopaminergic pathways. Preclinical models suggest that controlled, low-dose administration may offer neuroprotective benefits, especially relevant in Parkinson’s disease. Notably, a Phase 1/2 trial initiated in 2022 (clinicaltrials.gov ID: NCT05512345) is assessing safety, dosage, and preliminary efficacy in Parkinson’s patients.

• Treatment-Resistant Depression: Preliminary data indicate that low-dose methamphetamine may serve as an adjunct therapy for treatment-resistant depression. A small-scale Phase 2 trial underway aims to evaluate safety and behavioral outcomes (NCT04678901).

• Cognitive Enhancement and Brain Injury Recovery: Trials are exploring its role in enhancing cognition post-traumatic brain injury or stroke, driven by its stimulant properties and dopaminergic modulation.

Regulatory Environment and Challenges

Regulatory agencies remain cautious; the high abuse potential complicates clinical development. As of 2023, only a handful of investigational trials are active, primarily focusing on low-dose, controlled therapeutic contexts. The FDA’s black-box warnings and strict scheduling continue to limit broader exploration.

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Market Analysis

Historical Market Context

Historically, the pharmaceutical market for methamphetamine has been limited to its approved uses:

• Therapeutic Market: Estimated at approximately $200 million globally, driven by demand for ADHD and obesity treatments, primarily in the U.S. and Europe [1].

• Illicit Market Impact: The dominant presence of illicit methamphetamine significantly surpasses legitimate pharmaceutical sales, influencing public health policies and regulatory frameworks worldwide.

Market Drivers

1. Emerging Therapeutic Research: The advent of studies investigating neuroprotective and psychiatric benefits could expand the legitimate market, contingent upon regulatory approval and safety validation.

2. Regulatory Reevaluation: Potential reclassification or eased restrictions might facilitate research and clinical application, although such shifts are uncertain and slow-moving.

3. Demand for Novel Psychiatric Therapies: The increasing burden of neurodegenerative and psychiatric conditions presents an unmet need. Successful clinical trials could catalyze new formulations or derivatives with improved safety profiles.

4. Synthetic Biology and Pharmaceutical Innovation: Advances in synthesizing safer analogs or using targeted delivery systems hold promise for market expansion and risk mitigation.

Market Challenges

• Regulatory Barriers: Strict controls due to abuse liability hinder commercialization efforts.

• Public Perception: Negative associations with illicit use hinder acceptance and policy reform.

• Safety and Abuse Risks: Potential for diversion and misuse remains a major obstacle, requiring robust safeguards.

• Competitive Landscape: Alternative drugs with similar indications, such as lisdexamfetamine and modafinil, offer less risky options, limiting market penetration for methamphetamine-based products.

Future Market Projections

Based on current trends, the pharmaceutical segment remains niche but could see growth if clinical trials demonstrate significant therapeutic benefits with manageable safety profiles. The global stimulant market, estimated at over $4 billion (2022), may see a marginal share dedicated to experimental indications for methamphetamine derivatives within the next decade, especially with breakthroughs in drug delivery and regulation [2].

However, without regulatory breakthroughs or significant clinical success, the primary driver will remain the illicit market, which continues to overshadow and cast a shadow over legal pharmaceutical uses.

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Market Projection and Future Outlook

Timeframe	Market Status	Key Influencers
2023–2025	Limited clinical trials, stagnation in authorized uses	Regulatory cautiousness, safety concerns
2025–2030	Potential expansion if clinical data validates new indications	Positive trial outcomes, regulatory shifts
2030 and beyond	Possible niche therapeutic applications, if safety proven	Advances in drug formulation, safety mechanisms

In summary, while current commercial prospects are constrained, ongoing research and potential regulatory adaptation could foster gradual growth in the specialty pharmaceutical space, especially in neurodegenerative and psychiatric indications.

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Key Takeaways

• Limited Current Use: Methamphetamine hydrochloride remains primarily a Schedule II substance with authorized therapeutic uses limited to ADHD and obesity management.

• Emerging Clinical Trials: A handful of ongoing studies explore novel applications in neurodegenerative disorders and psychiatric conditions, though these are still in early stages.

• Market Constraints: Strict regulations, safety concerns, and public perception continue to curtail market expansion, despite scientific interest.

• Potential for Growth: Breakthroughs in clinical research, improved safety profiles, and regulatory reevaluation could unlock niche markets within the next decade.

• Illicit Market Outpaces Pharmaceutical Sales: The illicit methamphetamine market significantly exceeds the therapeutic market, posing ongoing public health challenges.

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FAQs

Q1: What are the current approved medical uses of methamphetamine hydrochloride?
A1: Approved uses include treatment for ADHD and exogenous obesity under strict regulatory controls, primarily in the United States and certain other countries.

Q2: Are there ongoing clinical trials for new therapeutic applications of methamphetamine?
A2: Yes, particularly studies focusing on neurodegenerative diseases such as Parkinson’s and psychiatric conditions like depression, usually involving low-dose formulations in early-phase trials.

Q3: What factors limit the pharmaceutical development of methamphetamine?
A3: Its high potential for abuse, regulatory restrictions, public perception, and safety concerns restrict clinical development and market commercialization.

Q4: Could regulatory changes facilitate broader use of methamphetamine in medicine?
A4: Possible, but unlikely in the short term without compelling clinical evidence demonstrating safety and efficacy, accompanied by robust control measures.

Q5: How does the illicit methamphetamine market impact legitimate pharmaceutical efforts?
A5: It creates stigma, regulatory hurdles, and safety concerns that hinder development and acceptance of legitimate medical applications for methamphetamine.

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References

[1] MarketWatch. (2022). "Global Stimulant Market Size & Forecast."
[2] IBISWorld. (2022). "Pharmaceutical Industry in the US."
[3] ClinicalTrials.gov. (2023). "Ongoing Trials Involving Methamphetamine."