Non-Abstinence Outcomes in Methamphetamine Use Disorder
ConditionMethamphetamine Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWilliam Stoops
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Contingency Management
BehavioralSubjects will receive payments for providing methamphetamine negative urine samples.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Contingency Management GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Time frame
At baseline.2
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Time frame
Week 1 of participation.3
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Time frame
Week 2 of participation.4
Mean Arterial Pressure
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Time frame
Week 3 of participation.Secondary outcomes
1
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Time frame
At baseline.2
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Time frame
Week 4 of participation.3
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Time frame
Week 8 of participation.4
Sleep
Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.
Time frame
Week 12 of participation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
William Stoops
Lead sponsor
University of Kentucky
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov