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Cocaine and Methamphetamine Have Zero FDA-Approved Treatments. New FDA Guidance and Three Active Trials Are Finally Changing That.

For the first time, the FDA has told researchers exactly how to run a trial for cocaine or meth — a critical step toward pharmacotherapy that does not yet exist for 57,500 annual deaths.

ByThe Rize NewsroomMay 22, 20262 min readStimulants

The scale of a problem with no approved solution

Here is an uncomfortable fact about the American overdose crisis: the two substances killing more people every year — methamphetamine and cocaine — have zero FDA-approved medications to treat them.

Opioid use disorder has three: methadone, buprenorphine, and naltrexone. Alcohol use disorder has four. But for the 57,500 Americans who died of stimulant-involved causes in 2022, and for the millions more still in active use, there is no equivalent of Suboxone.

What the FDA guidance does

The FDA recently published its first-ever draft guidance for clinical trial design specifically targeting cocaine use disorder, methamphetamine use disorder, and prescription stimulant use disorder. The guidance clarifies what counts as success, who to enroll, and how to design the control arm. For researchers who have spent years navigating regulatory ambiguity, this is a genuine unlock.

The pipeline

Mirtazapine showed an 8% lower daily risk of methamphetamine use versus placebo in a Phase 3 JAMA Psychiatry RCT (McKetin et al. 2026) at six Australian clinics. Already generic and cheap.

Extended-release naltrexone + bupropion is recruiting for Phase 3 (NCT06233799), primary completion October 2026.

IV ketamine for methamphetamine is in NIDA CTN planning stages.

What works right now

Contingency management is the most evidence-supported intervention for stimulant use disorder. The VA has implemented it broadly. Only California and Washington have Medicaid waivers covering it.

Residential treatment remains effective for severe methamphetamine use disorder, particularly programs using the Matrix Model.

Why this matters for people in recovery

Effective treatment exists — residential programs, intensive outpatient with CM, and medication-assisted support for co-occurring disorders. The research pipeline means pharmacotherapy options are genuinely coming.

At Rize, our matching algorithm factors in the type of services a facility offers — including whether a program uses the Matrix Model, offers CM, or specializes in stimulant use disorder. Find treatment options near you

Sources Cited

  1. 01.A
    FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use DisordersFDA
  2. 02.A
    NIDA CTN Stimulant Use Disorder Task Force Results: 2024 UpdateDrug and Alcohol Dependence Reports
  3. 03.A
    Trial of Extended-Release Naltrexone/Bupropion for Methamphetamine Use DisorderClinicalTrials.gov
  4. 04.B
    Contingency Management for Stimulant Use Disorder and Opportunities for State Medicaid CoverageHealth Law and Policy Brief

Filed Under

sciencepolicytreatmentMethamphetamineCocaineTreatmentPolicyScience

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