Clinical trial NCT02189915: Open-Label Creatine Study for Female Meth Users
Official title: Open-Label Creatine Monohydrate Supplementation in Depressed Female Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Dual Diagnosis
Substance Use
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 14
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Must be female
2. Must be between the ages of 13 and 55 years
3. Methamphetamine must be primary drug of choice
4. Must have used methamphetamine within the last 6 months
5. For participants \> 18 years of age, must have a Hamilton Depression Rating Scale (HDRS or HAM-D) score of \> 17
6. For participants \< 18 years of age, must have a Children Depression Rating Scale (CDRS) score of \> 40
7. Must be able to give informed consent

Exclusion Criteria:

1. Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
2. DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
3. Known pregnancy or positive urine HCG test
4. Current serious homicidal or suicidal risk
5. Young Mania Rating Scale (YMRS) score \> 7
6. Inability to comply with the protocol
7. Contraindication to an MR scan
8. Positive HIV test
9. Known sensitivity to creatine monohydrate

Inclusion criteria for healthy comparison group:

1. Must be female
2. Must be between the ages of 13 and 55 years
3. Must be able to give informed consent

Exclusion criteria for healthy comparison group:

1. Significant current medical illness
2. DSM-IV disorder identified by the SCID (to include bipolar I, bipolar II, bipolar NOS, major depressive disorder, dysthymia disorder, depressive disorder NOS, primary psychotic symptoms, substance use disorders, and anxiety disorders)
3. Known pregnancy or positive urine HCG test
4. Contraindication to an MR scan
5. Inability to comply with the protocol
6. Positive urine drug screen (unless it is positive for a low dose prescription opiate that is taken as prescribed)

Primary outcomes:
measure: Depression Rating Scores
timeFrame: 8-week
Secondary outcomes:
measure: Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Perry Renshaw, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: