Open-Label Creatine Study for Female Meth Users

NCT02189915 | Terminated Results

• 1 other identifier: 53737
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Depression Rating Scores

  Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.

  8-week

Secondary Outcomes (1)

• Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy

  8 weeks

Study Arms (1)

Creatine monohydrate

EXPERIMENTAL

Drug: Creatine monohydrate

Interventions

Creatine monohydrate DRUG

Creatine monohydrate

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Significant current or past medical conditions, such as cardiovascular, renal or endocrine disorders
• DSM-IV diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
• Known pregnancy or positive urine HCG test
• Current serious homicidal or suicidal risk
• Young Mania Rating Scale (YMRS) score \> 7
• Inability to comply with the protocol
• Contraindication to an MR scan
• Positive HIV test
• Known sensitivity to creatine monohydrate
• Must be female
• Must be between the ages of 13 and 55 years
• Must be able to give informed consent
• Significant current medical illness
• 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)
• Known pregnancy or positive urine HCG test

Sponsors & Collaborators

• Perry Renshaw: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depression; Substance-Related Disorders

Interventions

Creatine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Perry Renshaw, MD, PhD, MBA
• Organization: The Brain Institute of the University of Utah

perry.renshaw@hsc.utah.edu

801-587-1216

Study Officials

• Perry Renshaw, MD, PhD, MBA

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 15, 2014
• Study Start: January 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 20, 2016
• Results First Posted: May 20, 2016

Record last verified: 2016-04

Locations

US (1)