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UTSW-led studies are largest ever for stimulant use disorders

NIDA-funded trials will test possible treatments for methamphetamine, cocaine abuse

UT Southwestern Medical Center is leading three multicenter clinical trials funded by the National Institute on Drug Abuse (NIDA) focused on potential treatments for methamphetamine or cocaine addiction.

Madhukar Trivedi, M.D.

Madhukar Trivedi, M.D., Professor of Psychiatry at UT Southwestern, holds the Betty Jo Hay Distinguished Chair in Mental Health and the Julie K. Hersh Chair for Depression Research and Clinical Care.

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, said Principal Investigator Madhukar Trivedi, M.D., Professor of Psychiatry at Peter O’ Donnell Jr. Brain Institute.

“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. These studies could offer the first medical treatments for individuals suffering from stimulant addictions and help them regain control over their lives,” said Dr. 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.

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), according to NIDA. Tens of thousands die from these chronic conditions each year, and those who survive typically have vast disruptions in their social relationships, work, and other aspects of daily life.

The three studies, funded at a total of nearly $30 million, are evaluating the effectiveness of drugs and other therapies for the conditions. 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, 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 Dr. Trivedi’s 2021 study.

Dr. Trivedi has also received funding from NIDA for several smaller trials focused on other aspects of substance use disorders. 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,” Dr. Trivedi said. “These trials may result in treatments that can truly help patients.”

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