RecruitingPhase 3NCT02568878

Creatine for Depressed Male and Female Methamphetamine Users

An Open-Label Pilot Study of Creatine for Depressed Male and Female Methamphetamine Users

Sponsor

Montana State University

Enrollment

29 participants

Start Date

Nov 1, 2015

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety Methamphetamine Dependence

Summary

* 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

Eligibility

Min Age: 18 YearsMax Age: 59 Years

Inclusion Criteria6

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 Criteria7

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