A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
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|ClinicalTrials.gov Identifier: NCT02192931|
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : October 11, 2018
Methamphetamine (MA) addiction is a public health concern that causes substantial harm to individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion annually. This study proposes to address a critical aspect of this problem: the lack of any proven, FDA-approved pharmacological treatments for MA users. The proposal combines an intervention designed to improve energy metabolism in the brain, and a neuroimaging technique capable of measuring the neurochemicals that represent cerebral bioenergetic function. The study will replicate and extend a key neuroimaging finding from the investigators recent MA studies: that MA users have decreased phosphocreatine (PCr) levels in the brain, compared to healthy volunteers. Phosphocreatine is the substrate reservoir for the creatine kinase reaction, which reversibly converts PCr into adenosine triphosphate (ATP), the brain's major energy supply, and creatine. Neuronal energy demands are met through a shift in reaction equilibrium, which is designed to maintain the concentration of ATP constant. Research results from the investigators recent study also showed that female MA users have lower brain PCr levels compared to male users. These findings join the converging lines of evidence that MA use is associated with mitochondrial dysfunction, i.e. deficient energy metabolism, in the brain. Frequently, MA users also experience depression, as well as cognitive deficits. Interestingly, both of these entities are also linked to mitochondrial dysfunction in the brain.
The long-term goal of this research program is to define the alterations in brain chemistry that underlie MA use disorders, and to utilize translational magnetic resonance spectroscopy (MRS) neuroimaging to identify rational brain-based treatment targets. Once a hypothesis-driven intervention is identified, MRS can then be further employed in treatment studies, to verify that "target engagement" is achieved. The specific aims of this proposal are an example of this stepwise scientific process: the nutritional supplement creatine will be tested in a randomized, placebo-controlled study of women with MA use disorders, to investigate creatine's effect on cerebral PCr levels, depressive symptoms, and MA usage.
|Condition or disease||Intervention/treatment||Phase|
|Depression Dual Diagnosis Drug Addiction||Drug: Creatine monohydrate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Active Comparator: Creatine monohydrate
5 grams of daily creatine monohydrate for 8 weeks
Drug: Creatine monohydrate
Placebo Comparator: Placebo
5 g of placebo for 8 weeks
Drug: Creatine monohydrate
|No Intervention: Healthy Control|
- Hamilton Depression Rating Scale (HAMD) scores [ Time Frame: 8-weeks ]Change in HAMD scores will be evaluated over the course of the 8-week treatment period.
- Beck Anxiety Inventory (BAI) scores [ Time Frame: 8-weeks ]Change in BAI scores will be evaluated over the course of the 8-week treatment period.
- Neurochemistry measured by magnetic resonance spectroscopy [ Time Frame: 8-weeks ]Neurochemistry, such as PCr, NAA and GABA, will be measured pre- and post-creatine/placebo treatment.
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): NCT02192931
|Contact: Lindsay Scholl, BS||801 386 firstname.lastname@example.org|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Lindsay Scholl, BS 801-386-4773 email@example.com|
|Principal Investigator:||Perry Renshaw, MD, PhD, MBA||University of Utah|