NCT07226596

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Jan 2031

First Submitted

Initial submission to the registry

November 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2031

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

November 6, 2025

Last Update Submit

January 22, 2026

Conditions

Methamphetamine Use Disorder

Keywords

methamphetaminetreatmentbehavioral intervention

Outcome Measures

Primary Outcomes (17)

  • Mean Arterial Pressure

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

    At baseline.

  • Mean Arterial Pressure

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

    Week 1 of participation.

  • Mean Arterial Pressure

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

    Week 2 of participation.

  • Mean Arterial Pressure

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

    Week 3 of participation.

  • Mean Arterial Pressure

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

    Week 4 of participation.

  • Mean Arterial Pressure

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

    Week 5 of participation.

  • Mean Arterial Pressure

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

    Week 6 of participation.

  • Mean Arterial Pressure

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

    Week 7 of participation.

  • Mean Arterial Pressure

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

    Week 8 of participation.

  • Mean Arterial Pressure

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

    Week 8 of participation.

  • Mean Arterial Pressure

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

    Week 9 of participation.

  • Mean Arterial Pressure

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

    Week 10 of participation.

  • Mean Arterial Pressure

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

    Week 11 of participation.

  • Mean Arterial Pressure

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

    Week 12 of participation.

  • Endothelin-1

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

    At baseline.

  • Endothelin-1

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

    Week 6 of participation.

  • Endothelin-1

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

    Week 12 of participation.

Secondary Outcomes (4)

  • Sleep

    At baseline.

  • Sleep

    Week 4 of participation.

  • Sleep

    Week 8 of participation.

  • Sleep

    Week 12 of participation.

Study Arms (2)

Control Group

NO INTERVENTION

This group will receive payment for providing urine samples throughout the trial.

Contingency Management Group

EXPERIMENTAL

This group will receive payment for providing methamphetamine negative urine samples throughout the trial.

Behavioral: Contingency Management

Interventions

Contingency ManagementBEHAVIORAL

Subjects will receive payments for providing methamphetamine negative urine samples.

Contingency Management Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507, United States

RECRUITING

Study Officials

  • William W Stoops, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William W Stoops, PhD

CONTACT

8592575388william.stoops@uky.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2025

First Posted

November 10, 2025

Study Start

January 14, 2026

Primary Completion (Estimated)

January 4, 2031

Study Completion (Estimated)

January 4, 2031

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified participant level data will be findable and identifiable using the unique number assigned to this grant application by NIDA. Where the data are available and how to access the data will be identified in any publications and presentations about these data. The repository and funding source will also be acknowledged in any publications and presentations. The Open Science Framework, which is a generalist repository, will be the data repository. This repository has policies and procedures in place that will provide data access to qualified researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
No later than one year after the completion of the funded project period. Data will be available indefinitely after that.
Access Criteria
Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes.

Locations

US(1)