NCT07226596 · William Stoops
Non-Abstinence Outcomes in Methamphetamine Use Disorder
(RCT (05))
What this study is about
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this goal measurement in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced methamphetamine use.
View original scientific description
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced methamphetamine use. These data will be used to change current accepted methamphetamine treatment endpoints and accelerate identification of therapies for methamphetamine use disorder.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- be age 18 years or older;
- self-report methamphetamine use in the week prior to screening;
- provide a methamphetamine-positive urine sample at screening;
- meet DSM-5 criteria for moderate-severe Methamphetamine Use Disorder (MUD);
- be seeking treatment for their methamphetamine use
- be able and willing to commit to the 12-week intervention, as well as the 12-week post-intervention follow-up
- Individuals who meet these criteria and are stably maintained on buprenorphine or methadone for Opioid Use Disorder (OUD) will also be eligible to participate.
Exclusion criteria
- current or past medical or psychiatric illness (e.g., physical dependence on any drug other than buprenorphine requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, severe diagnosis for a SUD other than MUD or treated OUD) that would interfere with study participation in the opinion of the study physicians
- poor venous access precluding blood draws
Where
- Lexington, Kentucky
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations