Creatine for Depressed Male and Female Methamphetamine Users
Recruiting · NCT02568878 · Interventional (participants receive a specific treatment) · Lead sponsor: Montana State University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
* Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users * Assess creatine's effect on methamphetamine use * Assess the safety of creatine in male methamphetamine users with depression
Who can take part
Age range
18 Years to 59 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse
- Current diagnosis of major depressive disorder (primary or substance-induced)
- Current diagnosis of an anxiety disorder (primary or substance-induced)
- Current Hamilton Depression Rating scale score \> or = to 16
- Current Hamilton Anxiety Scale score \> = to 18
- If taking a psychotropic medication for depressed or anxious mood, regimen must be stable for \> = to 4 weeks prior to creatine treatment initiation
Exclusion criteria
- Persons unable to provide adequate informed consent
- Persons who are at clinically significant suicidal or homicidal risk
- Primary substance-related diagnosis other than methamphetamine dependence or abuse
- Positive pregnancy test (females only)
- History of renal disease
- Clinically significant medical or neurological illness identified by history, physical exam and laboratory testing
- History of hypersensitivity reaction to creatine
Where it is running
1 location listed across 1 US state.
- Montana State University College of Nursing (Missoula campus) - Missoula, Montana, United States