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Non-Abstinence Outcomes in Methamphetamine Use Disorder

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07226596
Acronym
RCT (05)
Enrollment
300
Registered
2025-11-10
Start date
2026-01-14
Completion date
2031-01-04
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Use Disorder

Keywords

methamphetamine, treatment, behavioral intervention

Brief summary

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.

Interventions

BEHAVIORALContingency Management

Subjects will receive payments for providing methamphetamine negative urine samples.

Sponsors

William Stoops
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Arterial PressureAt baseline.Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Endothelin-1At baseline.Endothelin-1 levels will be measured. They will be recorded in pg/ml.

Secondary

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

Countries

United States

Contacts

CONTACTWilliam W Stoops, PhD
william.stoops@uky.edu8592575388
PRINCIPAL_INVESTIGATORWilliam W Stoops, PhD

University of Kentucky

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026