Creatine for Depressed Male and Female Methamphetamine Users
NCT ID: NCT02568878
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
29 participants
INTERVENTIONAL
2015-11-30
2017-05-31
Brief Summary
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* Assess creatine's effect on methamphetamine use
* Assess the safety of creatine in male methamphetamine users with depression
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Creatine monohydrate
5 grams of daily creatine monohydrate by mouth for 8 weeks
Creatine monohydrate
Interventions
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Creatine monohydrate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
59 Years
ALL
No
Sponsors
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Montana State University
OTHER
Responsible Party
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Tracy Hellem
Assistant Professor
Principal Investigators
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Tracy Hellem, PhD
Role: PRINCIPAL_INVESTIGATOR
Montana State University
Locations
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Montana State University College of Nursing (Missoula campus)
Missoula, Montana, United States
Countries
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Central Contacts
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Facility Contacts
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Tracy Hellem, PhD
Role: primary
Role: backup
Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id