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....

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	18
Substance Abuse	16
Amphetamine-Related Disorders	11

Condition MeSH

Condition MeSH for Methamphetamine Hydrochloride
Intervention	Trials
Substance-Related Disorders	30
Amphetamine-Related Disorders	20
Disease	8
HIV Infections	7

Clinical Trial Locations for Methamphetamine Hydrochloride

Trials by Country

Trials by Country for Methamphetamine Hydrochloride
Location	Trials
United States	156
Canada	5
China	5
Malaysia	3
Australia	2

Trials by US State

Trials by US State for Methamphetamine Hydrochloride
Location	Trials
California	55
Texas	15
Arkansas	9
Utah	8
Illinois	8

Clinical Trial Progress for Methamphetamine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Methamphetamine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	6
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Methamphetamine Hydrochloride
Clinical Trial Phase	Trials
Completed	78
Unknown status	16
Recruiting	14

Clinical Trial Sponsors for Methamphetamine Hydrochloride

Sponsor Name

Sponsor Name for Methamphetamine Hydrochloride
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	64
University of California, Los Angeles	22
Baylor College of Medicine	9

Sponsor Type

Sponsor Type for Methamphetamine Hydrochloride
Sponsor	Trials
Other	161
NIH	67
Industry	16

Methamphetamine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Methamphetamine hydrochloride, a potent and intensely addictive stimulant, has been a focus of both medical and illicit use. This article delves into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials for Methamphetamine Use Disorder

Ketamine-Assisted Psychotherapy

A recent clinical trial at the University of California, San Francisco (UCSF), aims to investigate the feasibility and safety of using intramuscular (IM) ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in patients with or at risk for HIV. This Phase 2 pilot study involves 12 participants who will receive three doses of IM ketamine and seven sessions of manualized psychotherapy. The trial assesses the feasibility, safety, and tolerability of this treatment approach[1].

Monoclonal Antibody Treatment

The University of Arkansas for Medical Sciences (UAMS) is conducting a Phase 2 clinical trial for IXT-m200, a monoclonal antibody designed to counter the effects of methamphetamine. Funded by a $13.8 million NIH grant, this trial, known as the OUTLAST trial, aims to reduce or prevent the euphoric effects of methamphetamine by keeping it in the bloodstream and out of the brain. IXT-m200 has received FDA Fast Track Designation, indicating its potential to address an unmet medical need[3].

Two-Drug Combination Therapy

A UCLA-led clinical trial, ADAPT-2, has shown promising results using a combination of injectable naltrexone and extended-release oral bupropion (NTX+BUPN) to treat methamphetamine use disorder. The study found a 27% increase in methamphetamine-negative urine tests in the treatment group compared to an 11% increase in the placebo group, indicating reduced methamphetamine use up to 12 weeks after treatment initiation[4].

Market Analysis

Global Market Size and Growth

The global methamphetamine market was valued at USD 557.16 million in 2022 and is projected to reach USD 881.32 million by 2030, growing at a CAGR of 5.9% during the forecast period 2023-2030. This growth is driven by the increasing demand for methamphetamine hydrochloride (Desoxyn) for medical conditions such as ADHD, exogenous obesity, and narcolepsy[2].

Market Segmentation

The market is segmented based on the route of administration, with the oral segment holding the highest market share due to its convenience, non-invasiveness, and cost-effectiveness. The oral route is commonly used for treating ADHD, obesity, and narcolepsy[2].

Regional Analysis

Europe is expected to be the fastest-growing region due to the increasing demand for Desoxyn for various medical conditions and the presence of a well-established regulatory framework for the pharmaceutical industry. Key players in this region include Recordati S.p.A. and Hikma Pharmaceuticals plc[2].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the global methamphetamine market due to lockdowns, travel restrictions, and disruptions in supply chains. However, the market is expected to recover as these restrictions ease and production and distribution normalize[2].

Market Drivers and Challenges

Drivers

• The pleasurable effects of methamphetamine and its increasing demand as a medication for ADHD and other conditions are significant drivers of the market.
• The convenience and effectiveness of oral administration routes contribute to the market growth[2].

Challenges

• The illicit use and misuse of methamphetamine pose significant challenges, including legal and regulatory hurdles.
• The lack of FDA-approved medications for methamphetamine use disorder and overdose complicates treatment efforts[3][4].

Future Projections

Expanding Medical Applications

The demand for methamphetamine hydrochloride is expected to increase as its applications in treating ADHD, obesity, and narcolepsy expand. Companies are likely to benefit from broadening their product offerings to countries with higher incidences of these conditions[2].

Innovative Treatments

Clinical trials like those involving ketamine-assisted psychotherapy and monoclonal antibody treatments (e.g., IXT-m200) may offer new avenues for treating methamphetamine use disorder. Successful outcomes from these trials could lead to new treatment options and market growth[1][3].

Regulatory Support

The FDA Fast Track Designation for drugs like IXT-m200 indicates a regulatory environment that supports the development of treatments for serious and unmet medical needs. This support is likely to facilitate faster approval and market entry for innovative treatments[3].

Key Takeaways

• Clinical trials are underway to explore new treatments for methamphetamine use disorder, including ketamine-assisted psychotherapy and monoclonal antibody treatments.
• The global methamphetamine market is projected to grow significantly, driven by increasing demand for medical applications.
• Europe is expected to be a key growth region due to its regulatory framework and market demand.
• The COVID-19 pandemic had a temporary negative impact on the market, but recovery is anticipated.
• Innovative treatments and regulatory support are crucial for addressing the unmet medical needs related to methamphetamine use disorder.

FAQs

What is the current status of clinical trials for methamphetamine use disorder?

Clinical trials are ongoing, including a UCSF trial on ketamine-assisted psychotherapy and a UAMS trial on the monoclonal antibody IXT-m200. These trials aim to find effective treatments for methamphetamine use disorder[1][3].

How is the global methamphetamine market projected to grow?

The global methamphetamine market is projected to grow from USD 557.16 million in 2022 to USD 881.32 million by 2030, at a CAGR of 5.9% during the forecast period 2023-2030[2].

What are the main drivers of the global methamphetamine market?

The main drivers include the pleasurable effects of methamphetamine and its increasing demand as a medication for ADHD and other medical conditions[2].

How has COVID-19 impacted the methamphetamine market?

COVID-19 has negatively impacted the market due to lockdowns, travel restrictions, and supply chain disruptions. However, the market is expected to recover as these restrictions ease[2].

Are there any FDA-approved medications for methamphetamine use disorder?

Currently, there are no FDA-approved medications specifically for methamphetamine use disorder. However, clinical trials are exploring various treatment options, including combination therapies and monoclonal antibodies[3][4].

Sources

1. Ketamine Therapy for Methamphetamine Use Disorder & HIV. ClinicalTrials.gov.
2. Methamphetamine Market | Size, Share, Growth | 2023 - 2030. Virtuemarketresearch.com.
3. NIH Awards $13.8 Million to Test UAMS-Discovered Drug for Methamphetamine Use Disorder Treatment. News.uams.edu.
4. Clinical trial shows promising results in a two-drug combination that reduces methamphetamine use. UCLAhealth.org.