Status:
COMPLETED
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
Lead Sponsor:
Perry Renshaw
Conditions:
Depression
Dual Diagnosis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
Brief Summary
Methamphetamine (MA) addiction is a public health concern that causes substantial harm to individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion annually. This study...
Eligibility Criteria
Inclusion
- Female gender, ages 18-55 inclusive
- Current primary diagnosis of MA dependence or abuse, with MA preferred drug of abuse
- Current diagnosis of Major Depressive Disorder
- Current HAMD score \> 15
- Clinical Global Impressions Severity depression score \> 4
- If currently taking a psychotropic medication for depressed mood, regimen must be stable for \> 4 weeks before randomization
Exclusion
- Persons unable to provide adequate consent
- Persons who are at clinically significant suicidal or homicidal risk
- Primary substance-related diagnosis other than MA dependence or abuse
- Comorbid substance dependence diagnosis, other than nicotine (substance abuse diagnoses are not excluded)
- Positive pregnancy test
- Positive test for the antibody to the Human Immunodeficiency Virus (HIV)
- History of renal disease
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02192931
Start Date
September 1 2014
End Date
January 31 2023
Last Update
April 8 2025
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108