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.