A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
Primary Purpose
Depression, Dual Diagnosis, Drug Addiction
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Creatine monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Creatine monohydrate
Placebo
Healthy Control
Arm Description
5 grams of daily creatine monohydrate for 8 weeks
5 g of placebo for 8 weeks
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale (HAMD) scores
Change in HAMD scores will be evaluated over the course of the 8-week treatment period.
Secondary Outcome Measures
Beck Anxiety Inventory (BAI) scores
Change in BAI scores will be evaluated over the course of the 8-week treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02192931
Brief Title
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
Official Title
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Perry Renshaw
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Dual Diagnosis, Drug Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Creatine monohydrate
Arm Type
Active Comparator
Arm Description
5 grams of daily creatine monohydrate for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 g of placebo for 8 weeks
Arm Title
Healthy Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Creatine monohydrate
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAMD) scores
Description
Change in HAMD scores will be evaluated over the course of the 8-week treatment period.
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI) scores
Description
Change in BAI scores will be evaluated over the course of the 8-week treatment period.
Time Frame
8-weeks
Other Pre-specified Outcome Measures:
Title
Neurochemistry measured by magnetic resonance spectroscopy
Description
Neurochemistry, such as PCr, NAA and GABA, will be measured pre- and post-creatine/placebo treatment.
Time Frame
8-weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Renshaw, MD, PhD, MBA
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
We'll reach out to this number within 24 hrs