Open-Label Creatine Study for Female Meth Users

Study Overview
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Brief Summary
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Study Purposes and Objectives: The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language. Methamphetamine use is of great concern in the state of Utah because it's the primary drug of threat in the state, and is the primary drug of choice among females between the ages of 18 and 24. The primary hypothesis of the study is that eight weeks of oral creatine supplementation will result in improvements in depression rating scores in female MA users. Secondary hypotheses include the following: 1) creatine supplementation will result in a decrease in the number of positive MA screens; 2) NAA and Cr concentrations will increase after eight weeks of oral creatine supplementation; and 3) PCr/β-NTP levels in the frontal lobe using 31P MRS will increase after eight weeks of creatine monohydrate oral supplementation.

Official Title
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Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users

Conditions
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Depression, Dual Diagnosis, Substance Use

Intervention / Treatment
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* Drug: Creatine monohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be female Must be between the ages of 13 and 55 years Methamphetamine must be primary drug of choice Must have used methamphetamine within the last 6 months For participants > 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of > 17 For participants < 18 years of age, must have a Children Depression Rating Scale (CDRS) score of > 40 Must be able to give informed consent Exclusion Criteria: Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder Known pregnancy or positive urine HCG test Current serious homicidal or suicidal risk Young Mania Rating Scale (YMRS) score > 7 Inability to comply with the protocol Contraindication to an MR scan Positive HIV test Known sensitivity to creatine monohydrate Inclusion criteria for healthy comparison group: Must be female Must be between the ages of 13 and 55 years Must be able to give informed consent Exclusion criteria for healthy comparison group: Significant current medical illness DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary psychotic symptoms, substance use disorders, and anxiety disorders) Known pregnancy or positive urine HCG test Contraindication to an MR scan Inability to comply with the protocol Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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> | Drug: Creatine monohydrate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Rating Scores | Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression. | 8-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy | Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless. | 8 weeks |