Open-Label Creatine Study for Female Meth Users

Perry Renshaw

Status: Terminated

Conditions: Dual Diagnosis; Substance Use; Depression

Treatments: Drug: Creatine monohydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02189915

53737

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 13 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Creatine monohydrate

Experimental group

Treatment:

Drug: Creatine monohydrate