Methamphetamine Use DisorderRCT (05)NCT07226596
Non-Abstinence Outcomes in Methamphetamine Use Disorder
A study testing Contingency Management in people with Methamphetamine Use Disorder, run by William Stoops at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to 4 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, 40507
William W Stoops, PhD, 859-257-5388, william.stoops@uky.edu
About this study
Official title: 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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Contingency Management
- Keywords
- methamphetamine, treatment, behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Subjects will receive payments for providing methamphetamine negative urine samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: At baseline.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 1 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 2 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 3 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 4 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 5 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 6 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 7 of participation.
Mean Arterial Pressure
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Measured: Week 8 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 8 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 9 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 10 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 11 of participation.
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Measured: Week 12 of participation.
Endothelin-1
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Measured: At baseline.
Endothelin-1
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Measured: Week 6 of participation.
Endothelin-1
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Measured: Week 12 of participation.
Secondary outcomes (4)
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Measured: At baseline.
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Measured: Week 4 of participation.
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Measured: Week 8 of participation.
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Measured: Week 12 of participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start14 Jan 2026
- Primary completion4 Jan 2031 (estimated)
- Study completion4 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Stoops
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, William Stoops, University of Kentucky
- Investigators
- William W Stoops, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226596
- Sponsor's protocol ID
- 107171
- Other IDs
- R01DA064144
- Acronym
- RCT (05)
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Non-Abstinence Outcomes in the Treatment of Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT07226596
- Acronym / sponsor ID
- RCT (05) / 107171
- Conditions
- Methamphetamine Use Disorder
- Keywords
- methamphetamine, treatment, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- William StoopsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 4 Jan 2031 (estimated)
- Study completion
- 4 Jan 2031 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will receive payment for providing urine samples throughout the trial. |
| Contingency Management Group | Experimental | Behavioral: Contingency ManagementThis group will receive payment for providing methamphetamine negative urine samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementSubjects will receive payments for providing methamphetamine negative urine samples. | Behavioural | Contingency Management Group |
Primary outcome
Mean Arterial Pressure
Time frame: At baseline.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 1 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 2 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 3 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 4 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 5 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 6 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 7 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 8 of participation.
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 8 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 9 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 10 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 11 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
Time frame: Week 12 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Endothelin-1
Time frame: At baseline.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Endothelin-1
Time frame: Week 6 of participation.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Endothelin-1
Time frame: Week 12 of participation.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
4 secondary outcomes
Sleep
Time frame: At baseline.
Sleep
Time frame: Week 4 of participation.
Sleep
Time frame: Week 8 of participation.
Sleep
Time frame: Week 12 of participation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William W Stoops, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Methamphetamine Use Disorder, run by William Stoops at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William W Stoops, PhD (8592575388, william.stoops@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: At baseline.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.