ADAPT-2 Study Results: Although Low, Overall Response Drug Combo May Help Some Meth Addicts

ADAPT-2 Study Results: Although Low, Overall Response Drug Combo May Help Some Meth Addicts TrialsiteN

Although much attention has focused on the opioid epidemic, a parallel methamphetamine crisis rages on while the COVID-19 pandemic continues compounding health care problems across the United States and beyond. With no approved treatments, such as is the case for opioids, a new study, known as ADAPT-2, sponsored by the University of Texas Southwestern Medical Center, points to the potential for a combination of two drugs approved by the U.S. Food and Drug Administration (FDA): one approved for depression and the other for opioid addiction. Of the population under study, 13.6% revealed meth free urine in tests as compared to only 2.5% of those given a placebo. Meth addiction ravages human health and these study results should be at least reviewed by physicians and addiction health professionals.

Meth in America: a Crisis

Approved and regulated Schedule II of the Controlled Substances Act, the drug is approved for pharmacological use in the treatment of attention deficit hyperactivity disorder and treatment-resistant obesity, but it’s primarily abused as a recreational, illicit drug. As many as 440,000 people per month are using the drug illicitly. The drug is controlled in some areas by Mexican drug cartels and was made well-known by the television series “Breaking Bad.” As reported by the National Institute on Drug Abuse, meth deaths continue to rise.

The Study

With the results published in the New England Journal of Medicine, the study (NCT03078075), known as ADAPT-2, was sponsored by the University of Texas Southwestern Medical Center, in combination with the National Institute of Drug Abuse (NIDA) as well as the prominent the contract research organization (CRO), called The Emmes Company, LLC. Led by Principal investigator Madhukar H. Trivedi, MD, the study’s protocol called for 403 participants in the double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder.

Principal investigator Madhukar Trivedi commented on the study, “This is a very serious illness with fatal consequences for which there are no available treatments.” Dr. Trivedi stated, “There is hope now for methamphetamine disorder.”

The Results

As reported in the NEJM, the overall responses were low. The 403 total participants were segmented into “stage 1” and 225 patients in “stage 2.” In this first stage, 16.5% of the total in the naltrexone and bupropion group and 3.4% in the placebo group had any response. Meanwhile, in the stage 2 group, 11.4% in the naltrexone and bupropion group responded, while in group 2, 1.8% of the placebo had any response. Hence, the weighted average reported was 13.6% with naltrexone and bupropion and 2.5% with placebo for an overall treatment effect of 11.1 percentage points–the Wald z test statistic came to 4.53; P<0.001.

Some adverse events were reported with the drug combination groups, such as gastrointestinal disorders, tremors, malaise, hyperhidrosis and anorexia. Of the total in the naltrexone and bupropion group, 3.6% (8 of 223) experienced some form of a serious adverse event.

The study team came to the conclusion that those fighting methamphetamine use disorder during a 12 week period taking a combination of extended-release injectable naltrexone and oral extended-release bupropion that overall response was “low” but was considerably higher than those of patients on placebo.

Trial Site Organization Participation

The study involved support from some prominent health centers. In California, the University of California, Los Angeles Center for Behavioral Addiction Medicine (CBAM) participated, as did the Substance Use Research Unit (SURU) at the San Francisco Department of Public Health. In the Pacific Northwest recovery organization, CODA Inc. participated, while up in Minnesota, Hennepin County Medical Center—Berman Center for Research was actively involved. In South Carolina, the study involved Pickens County Behavioral Health Services (BHS), while the nexus of the study, of course, was the University of Texas Southwestern Medical Center along with the University of Texas Health Science Center’s Center for Neurobehavioral Research on Addiction (CNRA).

Funding & Support

The study was funded by NIH-based funding as well as government money from the Department of Health and Human Services and support from the Emmes Company. The biotech company Alkermes provided Vivitrol (extended-release naltrexone) and a matched placebo free of charge for use in the trial as part of a deal with NIDA.

Lead Research/Investigator

Madhukar H. Trivedi, MD 

Call to Action: Physicians and addiction professionals should review this study.