The investigators are conducting a 10-week brain imaging and medication study. They are doing the research to study the response of Attention-Deficit/ Hyperactivity Disorder (ADHD) in youth with Autism Spectrum Disorder (ASD) on extended-release formulation of mixed amphetamine salts (MAS) (also know as Adderall XR). The investigators also want to find out if taking MAS has any effect on the brains of children and adolescents with ADHD and ASD. This study will help researchers better understand how the use of MAS to treat ADHD effects children and adolescents with ASD. The investigators will compare MAS to a placebo. The placebo will look exactly like the MAS capsules but will contain no MAS. During this study, participants may get a placebo instead of MAS. Placebos are used in research studies to see if the study results are due to the study drug or due to other reasons.
Participants with ASD and ADHD will complete 4-weeks of treatment with the study medication or placebo. They will complete bi-weekly study visits virtually via a telemedicine platform with the study doctor and complete questionnaires. On alternating weeks, they will meet with a Massachusetts General Hospital (MGH) study team member to discuss medication adherence and potential side effects. Participants will have the option to attend all study visits in-person if participants prefer. They will also complete baseline and endpoint Magnetic Resonance (MR) scan visits at Massachusetts Institute of Technology (MIT). During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.
Participants without ADHD or ASD will complete eligibility screening with MGH. If eligible, they will be invited to baseline and endpoint MR scan visits at MIT. During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.

Start Date15 Oct 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT04635826

/ WithdrawnPhase 4IIT

The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.

Start Date01 Jul 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05650775

/ CompletedPhase 1IIT

Biomarkers of ADHD Treatment Response

The goal of this translational biomarker study is to use electroencephalography (EEG) to identify brain signatures that will predict a child's response to two of the most commonly prescribed ADHD medications, methylphenidate and mixed amphetamine salts. The main questions the investigators aim to answer are:
1. Do children with ADHD who show symptom reduction with methylphenidate have different EEG profiles than children who do not respond well to methylphenidate?
2. Do children who respond better to mixed amphetamine salts than to methylphenidate have unique EEG profiles?
The investigators will measure brain activity before the participating children have tried any stimulant medications, and then again after a 3-week trial of Concerta (methylphenidate). Participants who do not show significant symptom improvement on Concerta will then complete a 3-week trial of Adderall (mixed amphetamine salts), and the study will measure brain activity while those children are on the best dose of Adderall. The investigators will collect information from the child, caregivers, and teachers each week to measure ADHD symptom improvement and side effects. This study will therefore follow the typical treatment approach used in the Boston Children's Hospital Developmental Medicine Clinic, but the investigators will add measures of brain functioning before and after medication.

Start Date17 Feb 2023

Sponsor / Collaborator

The Children's Hospital Corp.

100 Clinical Results associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

100 Translational Medicine associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

100 Patents (Medical) associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

257

Literatures (Medical) associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

01 Nov 2025·ADDICTION

United States trends in non‐prescribed use of Adderall and Ritalin: Population Assessment of Tobacco and Health (PATH) Study estimates from 2013 to 2022

Article

Author: Mallama, Celeste ; Rising, Joshua P. ; Radin, Rose ; Parks, Michael J. ; Kimmel, Heather L. ; Han, Beth ; Compton, Wilson M. ; Creamer, MeLisa R.

Abstract:

Background and Aims:

Dispensing of prescription stimulants to adults has risen dramatically over the past decade. Examining trends in nonprescribed use of prescription stimulants can inform public health responses. Most studies in the United States (U.S.) have faced challenges in assessing trends over time due to changes in survey methodologies and variation in populations assessed. We examined data from the Population Assessment of Tobacco and Health (PATH) Study to assess changes in nonprescribed use of prescription stimulants in the U.S. from 2013 to 2022.

Design:

The PATH Study is an ongoing longitudinal study of U.S. youth and adults, representative of the civilian noninstitutionalized population. Repeated cross‐sectional estimates at each wave were used (8 total waves). Trends from Wave (W) 1 (September 2013–December 2014) to W7 (January 2022–April 2023) were assessed. Full‐sample and replicate weights were used; joinpoint analyses and wave‐to‐wave comparisons were applied to test trends.

Setting:

Civilian noninstitutionalized U.S. youth and adults.

Participants/Cases:

Youth aged 12–17 and adults aged 18 + were assessed, with a total of 45 727 participants at wave 1 (Ns vary by wave).

Measurements:

Past 12‐month (P12M) prevalence of nonprescribed use of Ritalin or Adderall was assessed. Nonprescribed use of stimulants was assessed across subgroups according to age (12–17, 18–24, 25–39, ≥40) and sex (male, female).

Findings:

While wave‐to‐wave comparisons showed fluctuations across certain waves, overall, there were no statistically significant changes in P12M prevalence of Ritalin or Adderall nonprescribed use (1.3% at W1 and 1.5% at W7) across the study period. However, statistically significant differences in trends existed across age groups. Among 12–17 year‐olds, nonprescribed use prevalence remained stable (1.4% in W1 and 1.5% in W7). Nonprescribed use prevalence also remained stable for 18–24‐year‐olds from W1 to W3, but then significantly declined (p = 0.016) from W3 (5.3%) to W7 (2.6%). There were no significant changes in nonprescribed use prevalence among 25–39‐year‐olds (1.7% in W1 and 2.4% in W7) and those aged ≥40 (0.3% in W1 and 0.9% in W7). Across most waves, young adults aged 18–24 had a statistically significantly higher prevalence of nonprescribed use. Neither sex had significant trends in P12M nonprescribed use prevalence.

Conclusions:

Despite an increase in dispensing of prescription stimulant medications in the United States, the prevalence of nonprescribed Ritalin or Adderall use does not appear to have increased, as assessed in the nationally representative Population Assessment of Tobacco and Health (PATH) Study. The prevalence of nonprescribed Ritalin or Adderall use among young adults aged 18–24, the age group with the highest nonprescribed use prevalence, declined 2013 to 2022.

01 Aug 2025·Journal of Mass Spectrometry and Advances in the Clinical Lab

Urine methamphetamine-to-amphetamine ratio by LC-MS/MS to differentiate methamphetamine use from pharmaceutical impurity in patients prescribed amphetamine

Article

Author: Kang, Phillip ; Tolan, Nicole V ; Thomas, Victoria L ; Snyder, Marion L ; Gildenberg, Melissa ; Melanson, Stacy E F ; Wolf, Clara E ; Contella, Lindsey

Introduction:

Patients compliant with prescribed amphetamine (AMPH) should not have detectable methamphetamine (METH) in their urine; detectable METH typically indicates illicit use. However, we have identified patients with results suggestive of METH as an impurity in prescribed AMPH.

Objectives:

Derive a METH:AMPH ratio cut-off from a training set of patients compliant with AMPH prescriptions to differentiate METH as an impurity from illicit use.

Methods:

Retrospective review of AMPH and METH-positive cases by liquid chromatography-tandem mass spectrometry (LC-MS/MS) at Brigham and Women's Hospital (BWH) and Luxor Scientific. Correlated results with clinical and medication history and compliance with prescribed medications.

Results:

The median ± interquartile range (IQR) METH:AMPH ratio for the Adderall training sets was 0.43 ± 0.31 % and 0.05 ± 0.040 %, with a maximum ratio of 1.125 % and 0.125 % at BWH and Luxor, respectively. The median ± IQR METH:AMPH ratio for the Luxor d-AMPH training set was 0.039 ± 0.028 %, with a maximum ratio of 0.09 %; not statistically different from the Adderall training set. Assessment of the BWH test set where METH < AMPH (n = 22) revealed that METH was likely due to an impurity (n = 10), distant METH mis/use (n = 11), or requiring further analysis (n = 1). METH was also detected by LC-MS/MS in a commercial AMPH calibrator and in Adderall XR.

Discussion:

METH may represent an impurity in the AMPH formulation. Laboratories are encouraged to define a METH:AMPH ratio below which an impurity is the likely explanation for METH and/or to increase the METH positivity cut-off to 50 or 100 ng/mL to reduce potential false-accusations of illicit METH use.

27 Mar 2025·Cureus Journal of Medical Science

A Case Report: Lisdexamfetamine-Induced Delusional Parasitosis

Article

Author: Kelsey, John ; Chen, Xialing Ann

Attention-deficit hyperactivity disorder (ADHD) is generally treated with stimulant medications without significant complications. Delusional parasitosis (Ekbom syndrome) can occur secondary to ADHD treatment. It is a rare condition defined as having a fixed, false belief that one is infected with insects, parasites, or organisms and that one experiences cutaneous sensations without any clinical evidence of infestation. Although stimulant treatment with methylphenidate or mixed amphetamine salts has been associated with delusional parasitosis, there is yet a case in the literature illustrating delusional infestation secondary to lisdexamfetamine. The following case is unique in that lisdexamfetamine caused delusional parasitosis in a 53-year-old man with ADHD who previously tolerated mixed amphetamine salts and armodafinil without side effects. The discontinuation of lisdexamfetamine, coupled with a second-generation antipsychotic, quickly resolved the delusion. For those who may prescribe lisdexamfetamine or treat patients with ADHD, it is crucial to carefully assess medication use, as discontinuation or dose adjustment of the suspected causative drug can have a positive impact on the course of delusional parasitosis.

133

News (Medical) associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

30 Oct 2025

·endpoints.news

Takeda makes some pipeline cuts, says generic competition softens Q2 sales

Takeda said Thursday it has ended work on several early- and mid-stage drug candidates, adding that its second quarter sales took a hit from “generic erosion” and “unfavourable” exchange rates. The Japanese drugmaker nixed an AstraZeneca-partnered candidate for multiple system atrophy called TAK-341 after it missed the primary and secondary endpoints in a Phase 2 trial, according to a financial report . It also terminated two Phase 1 programs for narcolepsy (TAK-925) and acute myeloid leukemia (TAK-012), citing “strategic considerations.” Takeda obtained TAK-012 as part of its 2021 acquisition of GammaDelta Therapeutics. The cell therapy candidate was one of several programs impacted by Takeda’s broader decision to end all work on cell therapies earlier this month. Elsewhere, the company dropped a MASH asset called TAK-647 as part of a “portfolio prioritization.” The drug was originally developed by Pfizer, which licensed it out to Shire in 2016. Takeda then acquired Shire for $62 billion in 2019. Takeda has been trimming its pipeline as part of a multi-year rehaul designed in part to focus its resources on six late-stage programs that it believes could deliver billions of dollars in sales. These include its narcolepsy candidate, oxeporexton, which had a positive Phase 3 readout in September. The company has also been bulking out its late-stage pipeline through deals, licensing a Phase 3 ADC and a Phase 3-ready bispecific from Innovent for $1.2 billion upfront earlier this month. Meanwhile, Takeda’s Q2 revenues, from July to September, slid about 4% from the same time last year to JPY 2.2 trillion ($14.3 billion). The drop was largely due to weaker sales in the company’s neuroscience franchise, driven by generic competition for its ADHD medicine Vyvanse in the US. Vyvanse sales plummeted about 46% to $692.6 million, while its other ADHD drug Adderall XR declined 33% to $68.8 million. Takeda’s major depressive disorder treatment Trintellix was separately impacted by the redesign of Medicare Part D, with sales down 7% to $370.2 million.

AcquisitionPhase 3Cell TherapyPhase 2Phase 1

03 Sep 2025

·www.einpresswire.com

Ascendant NYC Brings Attention to the Hidden Risks of Stimulant Misuse

Clinicians at Ascendant warn that long-term stimulant use can leave people drained, anxious, and vulnerable to depression. NEW YORK, NY, UNITED STATES, September 3, 2025 / EINPresswire.com / -- Ascendant Intensive Outpatient Program NYC , a boutique addiction treatment center in Midtown Manhattan, is calling attention to the growing dangers of stimulant misuse—from prescription drugs like Adderall ® to street drugs such as methamphetamine and crack cocaine. These substances are often prescribed or used with the intent to help, yet misuse has fueled a steady rise in dependence and treatment admissions nationwide. Prescription stimulants can be effective when taken as directed, particularly for conditions like ADHD. Still, misuse is common. Adderall ® , for instance, is sometimes taken without a prescription by students or professionals chasing sharper focus or more energy. Methamphetamine, though available in limited medical use under the name Desoxyn ® , is more often found in illicit forms that are unpredictable and highly addictive. Crack cocaine, a potent stimulant with a notorious reputation, continues to circulate on the streets under names like “snow” or “blow.” Misuse often goes beyond simply taking too many pills. Crushing and snorting Adderall ® , injecting meth, or smoking crack are all methods that intensify the high but dramatically increase health risks. Overdose, seizures, heart problems, and long-term cognitive decline are not rare outcomes. Federal data show that in 2021, more than 3.7 million people in the U.S. misused prescription stimulants, and cocaine was linked to nearly two out of five overdose deaths in 2016. Clinicians at Ascendant warn that long-term stimulant use can leave people drained, anxious, and vulnerable to depression. Withdrawal is another hurdle: cravings, paranoia, and mood swings make quitting extremely difficult without medical oversight. To support individuals and families, Ascendant NYC provides: 24/7 medical detox to manage withdrawal safely. Residential and outpatient programs for different stages of recovery. Therapies such as Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and trauma-focused care. Wellness services including mindfulness, art therapy, and peer counseling for lasting support. The center emphasizes that stimulant misuse doesn’t follow one profile. High school students, college athletes, busy executives, or individuals with existing mental health struggles may all be at risk. Recognizing early warning signs—such as erratic sleep, paranoia, or “doctor shopping”—can open the door to timely treatment. About Ascendant NYC Ascendant NYC is a boutique addiction treatment center located in Midtown Manhattan, offering detox, residential, and outpatient programs. Since 2018, the center has provided compassionate, evidence-based care for individuals struggling with substance use. With an emphasis on safety, privacy, and individualized treatment, Ascendant helps clients rebuild their lives with the tools and support needed for long-term recovery. Admission Office Ascendant Intensive Outpatient Program NYC +1 (917) 924-4456 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

20 May 2025

·www.prnewswire.com

Federal Indictment Against NJ Doctor Collapses in Stunning DOJ Reversal, as Obtained by Health Law Alliance

Prosecutors Dismiss All Charges in Nation's Last-Remaining Insys Prosecution SHORT HILLS, N.J., May 20, 2025 /PRNewswire/ -- The U.S. Department of Justice has dismissed all federal criminal charges against prominent New Jersey urologist Dr. Mukaram Gazi, who had been charged with accepting more than $130,000 in bribes from Insys Therapeutics in exchange for prescribing Subsys, a fentanyl-based medication, and unlawful distribution of controlled substances, including Adderall. The four-count indictment, which was part of a broader federal and state initiative targeting opioid-related misconduct, was dismissed in its entirety, with no plea agreement, no financial penalties, and no admission of guilt. All charges were dropped, including healthcare fraud, anti-kickback violations, and violations of the Controlled Substances Act. As a result of the dismissal, Dr. Gazi is the only individual among 35 individuals prosecuted for Insys-related offenses since 2014 to be exonerated. The victory was secured by Anthony Mahajan, a former federal prosecutor and now the founding partner of Health Law Alliance, a boutique law firm that specializes in defending healthcare professionals in complex civil, regulatory, and criminal matters. "This type of outcome is uncommon in federal healthcare prosecutions," noted a legal observer familiar with criminal cases involving medical professionals. The indictment, announced in November 2021, connected Dr. Gazi to Insys, whose executives, including founder John Kapoor, were convicted for unlawfully promoting Subsys for use in patients outside the FDA-approved label. However, the evidence in the case ultimately failed to support the accusations against Dr. Gazi, prompting federal prosecutors to dismiss the case shortly before trial. Dr. Gazi's defense relied, in part, on the authority given physicians under the law to prescribe drugs "off label" for the advancement of medicine and patient care. The law also permits doctors to be compensated appropriately by pharmaceutical and medical device companies for participating in "speaker programs" and other educational activities. The dismissal underscores the importance of prosecutorial restraint in complex medical cases, particularly where criminal prosecution may chill lawful behavior and inhibit patient care. For more information, contact Health Law Alliance at (800) 345-4125 or [email protected]. SOURCE Health Law Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

100 Deals associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate	-	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	United States	Teva Women's Health, Inc.	19 Jan 1960

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02979327 (CTgov)	Phase 4	-	30	Adderall (Adderall)	kghekbzowm(bpomvruzul) = vmqjyiyvko abnmvhpxqa (dgclaehsun, 2) View more	-	14 Jan 2025
				Placebo (Placebo)	kghekbzowm(bpomvruzul) = yuzftzwpnd abnmvhpxqa (dgclaehsun, 2) View more
NCT03945175 (MYDAYIS, CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	52	Placebo	cnrdipaiak(kjhqxrasrz) = stdtoswrqs zyxbkpmmlp (ptirsxpybo, 11.4) View more	-	29 Jun 2023
NCT03810703 (HAP, CTgov)	Phase 1	Bipolar II disorder	93	Placebo oral capsule (Placebo Arm)	cyfcrtiqge(fdjgyqkocy) = rgxrtieyvq gowmnjsztb (lpkvehrgeb, 8.84) View more	-	22 Feb 2023
				d-amphetamine (Amphetamine 10 mg Arm)	cyfcrtiqge(fdjgyqkocy) = jvcrblihiw gowmnjsztb (lpkvehrgeb, 4.46) View more
NCT02803229 (MJ-ADHD, CTgov)	Phase 2/3	Attention Deficit Disorder With Hyperactivity \| Cannabis withdrawal	33	Matched placebo (Placebo)	nctxzuwuhe = cdlskaftuv hqetroxhfg (fomkwyjuuz, aiqshaeikk - gxeasniikn) View more	-	09 Apr 2021
				Adderall-XR (Adderall-XR)	nctxzuwuhe = inrcgecdci hqetroxhfg (fomkwyjuuz, nzvtkksshe - xcpqdymyiz) View more
NCT03325881 (Pubmed) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	89	SHP465 MAS	brpxlpgxfc(oqhbqllmrx): difference = -1.9 (95% CI, -6.8 to 3.1), P-Value = 0.451 View more	Negative	01 Nov 2020
				Placebo
NCT03325894 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	141	SHP465-112+SHP465 (Group A (Antecedent Studies))	dommejvzgd = swrrwgrbgg ayabesboib (vqkbiobdtv, zhcqredavs - fvyzrkbjyp) View more	-	05 Feb 2020
				SHP465 (Group B (Direct Enrollment))	dommejvzgd = mmqraafywi ayabesboib (vqkbiobdtv, nkbmwlxlwi - xmxzttuizg) View more
NCT03327402 (CTgov)	Phase 1	Attention Deficit Disorder With Hyperactivity	24	SHP465	fpraabaryy(urcqoudwbo) = ozdkcrfahe kpgvgoytht (kgwlpsfplw, 32.6) View more	-	29 Jan 2020
NCT03530631 (CTgov)	Phase 4	-	4	Adderall (Adderall/Truth)	jvpdtpghia = dhdmcmttyk qophdpcerm (xdgdropmdp, tjibssdyot - bnqebmxoeh) View more	-	14 Oct 2019
				Placebo (Placebo/Truth)	jvpdtpghia = ytzzpaddox qophdpcerm (xdgdropmdp, pvsrcfsoea - znwnudqlqw) View more
NCT03325881 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	89	Placebo (Placebo)	abjotjrmpm(iguhqcyyyv) = rkmtzuvara oqnecwkenj (hiixueafpx, xpbobrnlck - izekapzshu) View more	-	13 Aug 2019
				SHP465 (SHP465)	abjotjrmpm(iguhqcyyyv) = yrafkqolaq oqnecwkenj (hiixueafpx, fchojjivod - jioxwkaflw) View more
NCT02466425 (Pubmed \| J Child Adolesc Psychopharmacol) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	264	SHP465 MAS	rjydcdzaew(gceogxvvpo): difference = -9.9 (95% CI, -13.0 to -6.8), P-Value = <0.001 View more	Positive	01 Feb 2018
				Placebo

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