Non-Abstinence Outcomes in Methamphetamine Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contingency Management.
- Who it may be relevant to
- Registry conditions: Methamphetamine Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Advancing Non-Abstinence Outcomes in the Treatment of Methamphetamine Use Disorder
Overview
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
- Behavioral Contingency Management
Subjects will receive payments for providing methamphetamine negative urine samples.
Primary outcome measures
- Mean Arterial Pressure [Time frame: At baseline.]
- Mean Arterial Pressure [Time frame: Week 1 of participation.]
- Mean Arterial Pressure [Time frame: Week 2 of participation.]
- Mean Arterial Pressure [Time frame: Week 3 of participation.]
- Mean Arterial Pressure [Time frame: Week 4 of participation.]
- Mean Arterial Pressure [Time frame: Week 5 of participation.]
- Mean Arterial Pressure [Time frame: Week 6 of participation.]
- Mean Arterial Pressure [Time frame: Week 7 of participation.]
- Mean Arterial Pressure [Time frame: Week 8 of participation.]
- Mean Arterial Pressure [Time frame: Week 8 of participation.]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Psychopharmacology of Addiction Laboratory — Lexington
Identifiers
NCT: NCT07226596 · 107171 · R01DA064144