Exercise in Methamphetamine Use Disorder Upregulation and Neural Function (NCT03709667) | Clinical Trial Compass
CompletedEarly Phase 1
Exercise in Methamphetamine Use Disorder Upregulation and Neural Function
United States113 participantsStarted 2019-06-26
Plain-language summary
The purpose of this research study is to determine the effects of an exercise intervention and health-education program on brain dopamine receptors and on cognitive functions that have been linked to these receptors.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Language: Participants must be fluent in English, as demonstrated by verbal skills sufficient to participate in a conversation, including the ability to ask and answer questions at a level that assures adequate understanding of the study. A comprehension quiz will be administered.
✓. Age 18-65 years
✓. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate to severe stimulant use disorder assessed by MINI.
✓. Vital Signs: Within the clinically acceptable normal range (e.g., resting pulse 50 to 99/min, blood pressure between 85-150 mm Hg systolic and 45-90 mm Hg diastolic.
✓. Labs: hematology and chemistry laboratory test results within normal (+/- 10%) limits.
✓. Right handed.
Exclusion criteria
✕. Neurological disease: history of seizure disorder, brain injury with loss of consciousness \> 30 min, or other neurological disorder that would interfere with informed consent, data interpretation or participant safety.
✕. Musculoskeletal disease that would prevent participation in exercise.
✕. Current psychotic disorder assessed by the MINI.
✕. Current suicidal ideation/plan, assessed by the Patient Health Questionnaire-9.
✕. Heart disease: Hypertension or unstable pulmonary or cardiovascular disease that would interfere with participation in the EX regimen
✕. Evidence of untreated or unstable medical illness, including endocrine, autoimmune, renal, hepatic, or active infectious disease, which might compromise safe participation (HIV+ participants must be receiving a stable regimen of antiretroviral medication throughout the course of the study).
✕. Pregnancy \[Women must provide negative pregnancy urine tests before study entry\].
✕. Asthma or use of theophylline, α- and β-adrenergic agonists, or other sympathomimetics.