UTSW Leads 3 Studies That Are Largest Ever for Stimulant Use Disorders

Hundreds of patients will participate in the trials at UT Southwestern and other sites across the country. According to the National Institute on Drug Abuse, an estimated 1.6 million people over age 12 in the U.S. have methamphetamine use disorder (MUD) and 1.4 million have cocaine use disorder (CUD).

drugs and a bank card

Researchers at Dallas’ UT Southwestern Medical Center are leading three multicenter clinical trials focused on potential treatment for methamphetamine or cocaine addiction that are funded by the National Institute on Drug Abuse (NIDA).

Dr. Madhukar Trivedi

UTSW said that hundreds of patients will participate in the trials at UT Southwestern and other sites across the country, making them the largest trials ever conducted for this purpose, Principal Investigator Madhukar Trivedi, M.D., Professor of Psychiatry, said in a statement.

“Prevalence of methamphetamine and cocaine use disorders continues to increase, and there are no treatments approved by the U.S. Food and Drug Administration for either of these conditions,” said Trivedi, an Investigator in the Peter O’Donnell Jr. Brain Institute and founding Director of the Center for Depression Research and Clinical Care at UT Southwestern. “These studies could offer the first medical treatments for individuals suffering from stimulant addictions and help them regain control over their lives.”

According to NIDA, an estimated 1.6 million people over age 12 in the U.S. have methamphetamine use disorder (MUD) and 1.4 million have cocaine use disorder (CUD).

It said that tens of thousands of people die from these chronic conditions annually, and those who survive typically have vast disruptions in their social relationships, work, and other aspects of daily life.

More on the studies

The three studies are funded at a total of nearly $30 million and are evaluating the effectiveness of drugs and other therapies for the conditions.

According to UTSW, they include:

  • A randomized, double-blind, placebo-controlled trial to test injections of extended-release naltrexone every three weeks and extended-release buprenorphine every four weeks for people with CUD. Naltrexone is prescribed for opioid use disorder and alcohol use disorder. A combination similar to this that used injections of extended-release naltrexone and oral sustained-release bupropion showed promise for patients with MUD in a study by Dr. Trivedi and colleagues published in 2021 in the New England Journal of Medicine.
  • A trial to test the feasibility and efficacy of transcranial magnetic stimulation for patients with either MUD or CUD. The procedure uses magnetic fields to stimulate cortical regions of the brain.
  • A trial comparing the feasibility, efficacy, and safety of intravenously delivered ketamine (an anesthetic) versus midazolam (a sedative) in patients with MUD.

A fourth study that is expected to begin next year is a randomized, double-blind, placebo-controlled trial to test the efficacy of extended-release naltrexone plus bupropion XL compared with matched injectable and oral placebo in reducing methamphetamine use in individuals with moderate or severe MUD.

This study is being done to replicate the findings from Trivedi’s 2021 study.

Seeking ‘treatments that can truly help patients’

Trivedi also has received funding from NIDA for several smaller trials focused on other aspects of substance use disorders, UTSW said.

These include a study aimed at developing new approaches to recruit Black patients with substance abuse disorders for clinical trials to reduce health disparities; a study exploring a potential method to supervise patients who take methadone at home to treat opioid abuse disorder; and a study assessing the feasibility of web-based software to help primary care physicians screen, diagnose, and prescribe treatments for opioid abuse disorder.

“Substance abuse disorders bring immense bias and stigma, but they are medical conditions that need treatments,” Trivedi said. “These trials may result in treatments that can truly help patients.”

Trivedi holds the Betty Jo Hay Distinguished Chair in Mental Health and the Julie K. Hersh Chair for Depression Research and Clinical Care, and also has served as a consultant to companies that develop treatments for substance abuse disorders.

UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education.

Its faculty members have received six Nobel Prizes and include 26 members of the National Academy of Sciences, 21 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators.

UTSW said its full-time faculty of more than 3,100 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments.

UT Southwestern physicians provide care in more than 80 specialties to more than 120,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 5 million outpatient visits a year, the school said.

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