University of Minnesota Medical School

Sleep Disorder Drug May Be Effective for Stimulant Abuse

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The wakefulness-promoting drug modafinil may be effective in the management of stimulant use disorders, especially when used along with other nonpharmacological interventions, new research shows.

Overdoses from opioids and fentanyl are currently in the spotlight, but stimulant use disorders are also a growing concern with many experts sounding the alarm that it is the next wave of addiction.

“Stimulant use is a serious public health concern in the United States, and as an addiction psychiatrist, I found it frustrating that there are no Food and Drug Administration-approved medications for the treatment of cocaine, methamphetamine, or other stimulant use disorders,” Patricia Dickmann, MD, medical director of addiction services at the Minneapolis VA Medical Center, University of Minnesota Medical School, told Medscape Medical News.

“I have a large patient population struggling with treatment-refractory stimulant use disorders, where the combination of bupropion and naltrexone is not effective, residential treatments are not effective, and I had read some smaller studies suggesting modafinil could be a possible treatment option,” Dickmann said.

The findings were presented here at the American Academy of Addiction Psychiatry (AAAP) 29th Annual Meeting.

Lower Abuse Potential

Modafinil antagonizes dopamine transporters to increase dopamine availability in the brain, but to a lower extent than amphetamines. Therefore, it has a lower potential for abuse or misuse compared with traditional prescription stimulants such as Adderall and Ritalin, she said.

Between July 2017 and September 2018, Dickmann and colleague Erica Dimitropoulos, PharmD, also from the Minneapolis VA Medical Center, performed a prospective case series of 15 patients seen in the Addiction Recovery Services clinic who had a DSM-5 diagnosis of stimulant use disorder.

The patients were offered treatment with off-label modafinil, titrated based on efficacy and tolerability.

All care, including psychotherapy and other psychotropic medications, was continued as usual. Five patients were diagnosed with cocaine use disorder, 10 patients with methamphetamine use disorder, and one patient was diagnosed with both.

The majority of patients had comorbid mental health disorders, including mood disorders, post-traumatic stress disorder, and schizophrenia, as well as comorbid substance use disorders.

None of the patients were prescribed atomoxetine, bupropion, naltrexone, stimulants, or topiramate, although one patient was prescribed mirtazapine for insomnia.

At the time of data collection (November 2018), the average prescribed dose of modafinil was 300 mg/day (range, 200 to 400 mg/day).

Self-reported stimulant use was reduced or eliminated in 10 patients (67%). Six patients (40%) reported abstinence, four patients (27%) reported reduced use, and five patients (33%) reported no change in use pattern. These self-reports were confirmed by urine drug screens. Two patients (13%) overused their prescribed modafinil.

Modafinil was well-tolerated in all cases, with no reported side effects, Dickmann said.

“These results are encouraging, and will be used to support the addition of modafinil to our formulary for use in patients with stimulant use disorders,” she said.

Limited Treatment Options

Jonathan C. Fellers, MD

Commenting on the findings for Medscape Medical News, Jonathan C. Fellers, MD, Tufts University School of Medicine and Director, Integrated Medication-Assisted Treatment, Maine Medical Center, Portland, said there are very limited treatment options for stimulant use disorders.

“Unlike opioids or alcohol, there’s no medications that we have available, so whenever you have a study that has a positive result it’s always encouraging,” Fellers told Medscape Medical News.

“Modafinil is a stimulant but it’s a mild stimulant. Instead of Adderall or Ritalin, which are schedule II stimulants, and have more abuse potential, modafinil is a schedule IV, which is less abusable,” he added.

Home Test for Pharyngitis May Reduce Unneeded Strep Cultures.

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A patient-driven approach to streptococcal pharyngitis diagnosis using a new home test score might save on unnecessary physician visits, cultures, and treatment, according to a retrospective cohort study published online November 4 in the Annals of Internal Medicine. However, some experts are skeptical of the home score algorithm and of its potential cost-savings.

“Globally, group A streptococcal (GAS) pharyngitis affects hundreds of millions of persons each year,” write Andrew M. Fine, MD, MPH, from the Division of Emergency Medicine-Main 1, Boston Children’s Hospital in Massachusetts, and colleagues. “In the United States, more than 12 million persons make outpatient visits for pharyngitis; however, clinicians cannot differentiate GAS pharyngitis from other causes of acute pharyngitis (for example, viral) on the basis of a physical examination of the oropharynx.”

Most cases of sore throat are viral, rather than bacterial, and therefore are self-limiting and transient even without antibiotic treatment. To classify risk for GAS pharyngitis and guide management of adults with acute pharyngitis, the American College of Physicians and Centers for Disease Control and Prevention recommend use of clinical scores to identify low-risk patients. According to consensus guidelines, such patients should not be tested or treated for GAS pharyngitis.

The goal of this study was to help patients decide when to visit a clinician for evaluation of sore throat. The study sample consisted of 71,776 patients at least 15 years of age who were evaluated for pharyngitis from September 2006 to December 2008 at one of a national chain of retail health clinics.

Using information from patient-reported clinical variables, as well as local incidence of GAS pharyngitis, the investigators created a score and compared it with the Centor score and other traditional scores, using information from clinicians’ assessments. Clinical variables in the new score were fever, absence of cough, and age.

The investigators estimated outcomes if patients who were at least 15 years of age with sore throat did not visit a clinician when the new score indicated less than 10% likelihood of GAS pharyngitis, compared with being managed by clinicians following guidelines using the Centor score. The researchers suggest that following this strategy would avoid 230,000 clinician visits in the United States each year, and that 8500 patients with GAS pharyngitis who would have received antibiotics under clinician management would not receive antibiotics.

A limitation of this approach is current lack of availability of real-time information about the local incidence of GAS pharyngitis, which is needed to calculate the new score. Study limitations include retrospective design and reliance on self-report of symptoms.

“A patient-driven approach to pharyngitis diagnosis that uses this new score could save hundreds of thousands of visits annually by identifying patients at home who are unlikely to require testing or treatment,” the authors write.

Experts Question Limitations and Cost-Savings of the New Score

In an accompanying editorial, Edward L. Kaplan, MD, MMC, from the Department of Pediatrics, University of Minnesota Medical School in Minneapolis, warns of limitations of the new home score. These include overly broad age range, as GAS pharyngitis is rare in persons older than 50 years, and the assumption that GAS pharyngitis has even prevalence across communities.

Dr. Kaplan recommends stratification by age categories and notes that uncomplicated GAS pharyngitis has not been reportable to health departments for several decades in most states, making incidence difficult to determine. Other limitations include failure to account for potential effects of the decisions made by the multiple clinicians from more than 70 clinics attended by patients in this sample, and lack of differentiation of true GAS infection from upper respiratory tract “carriers” among adults.

“Until we have a proven cost-effective vaccine to protect against Streptococcus pyogenes, we cannot expect the magnitude of this medical and public health issue to decrease,” Dr. Kaplan writes. “Even if a cost-effective vaccine is developed, how it may affect true infections and the carrier state in children may be entirely different in adults. Fine and colleagues have proposed an interim approach, but there are surely others.”

In a second editorial, Robert M. Centor, MD, from the University of Alabama at Birmingham in Huntsville, questions the potential cost-savings if the new score were widely used. Alternative strategies to improve treatment and reduce costs include clinical assessment that eliminates testing for patients at low risk, as well as the use of generic antibiotics for those with GAS pharyngitis. He also warns that all guidelines and recommendations for GAS pharyngitis apply only to patients who have had symptoms for fewer than 3 days.

“If symptoms persist or worsen, then the patient no longer has acute pharyngitis; therefore, we should use a different diagnostic and therapeutic approach,” he writes.

Other questions posed by Dr. Centor include whether patients would actually download and use such a test before deciding whether to seek medical care for sore throat and why many physicians, clinics, and emergency departments do not follow published guidelines recommending against antibiotic use for patients with low probability of GAS pharyngitis.

“Although the goals [of this study] are admirable, the approach does not seem practical or cost-saving,” Dr. Centor concludes. “We have more practical strategies for decreasing costs for patients with sore throat.