- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192931
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Yasmin Peralta, BS
- Phone Number: 801 386 4773
- Email: yasmin.peralta@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female gender, ages 18-55 inclusive
- Current primary diagnosis of MA dependence or abuse, with MA preferred drug of abuse
- Current diagnosis of Major Depressive Disorder
- Current HAMD score > 15
- Clinical Global Impressions Severity depression score > 4
- If currently taking a psychotropic medication for depressed mood, regimen must be stable for > 4 weeks before randomization
Exclusion Criteria:
- Persons unable to provide adequate consent
- Persons who are at clinically significant suicidal or homicidal risk
- Primary substance-related diagnosis other than MA dependence or abuse
- Comorbid substance dependence diagnosis, other than nicotine (substance abuse diagnoses are not excluded)
- Positive pregnancy test
- Positive test for the antibody to the Human Immunodeficiency Virus (HIV)
- History of renal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Healthy Control
|
|
Active Comparator: Creatine monohydrate
5 grams of daily creatine monohydrate for 8 weeks
|
|
Placebo Comparator: Placebo
5 g of placebo for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8-weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8-weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Perry Renshaw, MD, PhD, MBA, University of Utah
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 73034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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