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

W

William Stoops

Status

Enrolling

Conditions

Methamphetamine Use Disorder

Treatments

Behavioral: Contingency Management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07226596
R01DA064144 (U.S. NIH Grant/Contract)
107171

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups

Control Group
No Intervention group
Description:
This group will receive payment for providing urine samples throughout the trial.
Contingency Management Group
Experimental group
Description:
This group will receive payment for providing methamphetamine negative urine samples throughout the trial.
Treatment:
Behavioral: Contingency Management

Trial contacts and locations

1

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Central trial contact

William W Stoops, PhD

Data sourced from clinicaltrials.gov

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