Non-Abstinence Outcomes in Methamphetamine Use Disorder (RCT (05))

June 5, 2026 updated by: William Stoops

Advancing Non-Abstinence Outcomes in the Treatment of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40507
        • Recruiting
        • Psychopharmacology of Addiction Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
This group will receive payment for providing urine samples throughout the trial.
Experimental: Contingency Management Group
This group will receive payment for providing methamphetamine negative urine samples throughout the trial.
Behavioral: Contingency Management
Subjects will receive payments for providing methamphetamine negative urine samples.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure
Time Frame: At baseline.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
At baseline.
Mean Arterial Pressure
Time Frame: Week 1 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 1 of participation.
Mean Arterial Pressure
Time Frame: Week 2 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 2 of participation.
Mean Arterial Pressure
Time Frame: Week 3 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 3 of participation.
Mean Arterial Pressure
Time Frame: Week 4 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 4 of participation.
Mean Arterial Pressure
Time Frame: Week 5 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 5 of participation.
Mean Arterial Pressure
Time Frame: Week 6 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 6 of participation.
Mean Arterial Pressure
Time Frame: Week 7 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 7 of participation.
Mean Arterial Pressure
Time Frame: Week 8 of participation.
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Week 8 of participation.
Mean Arterial Pressure
Time Frame: Week 8 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 8 of participation.
Mean Arterial Pressure
Time Frame: Week 9 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 9 of participation.
Mean Arterial Pressure
Time Frame: Week 10 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 10 of participation.
Mean Arterial Pressure
Time Frame: Week 11 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 11 of participation.
Mean Arterial Pressure
Time Frame: Week 12 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Week 12 of participation.
Endothelin-1
Time Frame: At baseline.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
At baseline.
Endothelin-1
Time Frame: Week 6 of participation.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Week 6 of participation.
Endothelin-1
Time Frame: Week 12 of participation.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Week 12 of participation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline.
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.
Week 4 of participation.
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.
Week 8 of participation.
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.
Week 12 of participation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
William Stoops

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William W Stoops, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 107171
  • R01DA064144 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

No later than one year after the completion of the funded project period. Data will be available indefinitely after that.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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