Creatine for Depressed Male and Female Methamphetamine Users

Study Overview
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Brief Summary
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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

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

Conditions
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Depression, Anxiety, Methamphetamine Dependence

Intervention / Treatment
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* Drug: Creatine monohydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine monohydrate<br>5 grams of daily creatine monohydrate by mouth for 8 weeks | Drug: Creatine monohydrate<br> <br> * Other names: Creapure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD) Scores |  | This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation). | 
| Hamilton Anxiety Rating Scale (HAMA) Scores |  | This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported methamphetamine use |  | This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation). | 
| Incidence of treatment-emergent adverse events |  | Adverse events will be reviewed monthly for safety concerns and presented at study completed (anticipated: 12 months after study initiation). | 
| Percent of positive urine drug screens for methamphetamine |  | This data will be assessed after 12 participants have completed the study and again after a completed sample size of 24 is achieved. The data will be presented at study completion (anticipated: 12 months after study initiation). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Anxiety, Methamphetamine dependence