Open-Label Creatine Study for Female Meth Users
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|ClinicalTrials.gov Identifier: NCT02189915|
Recruitment Status : Terminated (Received funding for the next phase of the study)
First Posted : July 15, 2014
Results First Posted : May 20, 2016
Last Update Posted : May 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Dual Diagnosis Substance Use||Drug: Creatine monohydrate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
|Experimental: Creatine monohydrate||
Drug: Creatine monohydrate
- Depression Rating Scores [ Time Frame: 8-week ]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.
- Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189915
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Perry Renshaw, MD, PhD, MBA||University of Utah|