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NCT Number: NCT07226596

Non-Abstinence Outcomes in Methamphetamine Use Disorder

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.

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Key information

Conditions

Methamphetamine Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

Location status: Recruiting

Location contact

William W Stoops, PhD

CONTACT

[email protected]

859-257-5388

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contingency Management

Behavioral

Subjects will receive payments for providing methamphetamine negative urine samples.

Primary outcomes

  1. Mean Arterial Pressure

    Time frame: At baseline.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  2. Mean Arterial Pressure

    Time frame: Week 1 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  3. Mean Arterial Pressure

    Time frame: Week 2 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  4. Mean Arterial Pressure

    Time frame: Week 3 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  5. Mean Arterial Pressure

    Time frame: Week 4 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  6. Mean Arterial Pressure

    Time frame: Week 5 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  7. Mean Arterial Pressure

    Time frame: Week 6 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  8. Mean Arterial Pressure

    Time frame: Week 7 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  9. Mean Arterial Pressure

    Time frame: Week 8 of participation.

    Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg

  10. Mean Arterial Pressure

    Time frame: Week 8 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  11. Mean Arterial Pressure

    Time frame: Week 9 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  12. Mean Arterial Pressure

    Time frame: Week 10 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  13. Mean Arterial Pressure

    Time frame: Week 11 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  14. Mean Arterial Pressure

    Time frame: Week 12 of participation.

    Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg

  15. Endothelin-1

    Time frame: At baseline.

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  16. Endothelin-1

    Time frame: Week 6 of participation.

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

  17. Endothelin-1

    Time frame: Week 12 of participation.

    Endothelin-1 levels will be measured. They will be recorded in pg/ml.

Secondary outcomes

  1. Sleep

    Time frame: At baseline.

    Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.

  2. Sleep

    Time frame: Week 4 of participation.

    Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.

  3. Sleep

    Time frame: Week 8 of participation.

    Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.

  4. Sleep

    Time frame: Week 12 of participation.

    Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.

Study contacts

Contact information is provided by the study sponsor or research team.

William W Stoops, PhD

CONTACT

[email protected]

8592575388

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Advancing Non-Abstinence Outcomes in the Treatment of Methamphetamine Use Disorder

Acronym: RCT (05)

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Nov 10, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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