Open-Label Creatine Study for Female Meth Users

NCT ID: NCT02189915

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Depression; Dual Diagnosis; Substance Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Creatine monohydrate

Group Type: EXPERIMENTAL

Creatine monohydrate

Intervention Type: DRUG

Interventions

Creatine monohydrate

Intervention Type: DRUG

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

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

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

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Perry Renshaw

OTHER

Sponsor Role: lead

Responsible Party

Perry Renshaw

Professor of Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Perry Renshaw, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

53737

Identifier Type: -

Identifier Source: org_study_id