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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
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lindsay Scholl, BS 801 386 4773 lindsay.scholl@utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Lindsay Scholl, BS    801-386-4773    lindsay.scholl@utah.edu   
Sponsors and Collaborators
Perry Renshaw
Investigators
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Principal Investigator: Perry Renshaw, MD, PhD, MBA University of Utah

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Responsible Party: Perry Renshaw, Professor of Psychiatry, University of Utah
ClinicalTrials.gov Identifier: NCT02192931     History of Changes
Other Study ID Numbers: 73034
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors