We are recruiting depressed, female methamphetamine users who are between the ages of 18 and 55 years old.
Why Study Methamphetamine Use?
Methamphetamine is the primary drug of threat in Utah and accounts for 15.6% of substance abuse treatment admissions. Nearly 75% of those in treatment are women and mothers. Methamphetamine use often results in very negative psychological, social, legal and occupational consequences.
What Does Depression Have To Do With Meth Use?
Depression and methamphetamine use often occur together. Short- and long-term methamphetamine use can result in mood changes. Some individuals may begin using methamphetamine to alleviate symptoms of depression.
What Is Creatine?
Creatine occurs naturally in the body and is made in the liver and kidneys. Most of us eat about 2 grams of creatine in our food every day. It plays a part in many processes and chemical reactions in the body. Some medical conditions other than depression have been treated with creatine.
Will Creatine Affect My Drug Screens?
Creatine does not cause false positive drug tests.
What Is The Name Of The Study?
A Feasibility Placebo-Controlled Study of Creatine in Depressed Meth-Using Females
What Is A Placebo-Controlled Study?
In a placebo-controlled study, half of participants receive treatment (creatine) and half of participants receive a placebo so that researchers can see if creatine is truly a more effective treatment than having no treatment at all.
Who Can Be In The Study?
In order to be in the study you must meet these criteria:
- Methamphetamine must be your drug of choice.
- You have to have used within the past six months.
- You must be a female between the ages of 18 and 55 years.
- You must meet criteria for depression during your screening visit.
- You cannot have a current DSM-IV or DSM-V diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Your HIV and pregnancy tests must be negative.
- You cannot have a significant current or past medical, neurological, or psychiatric co-morbidity.
What Are The Benefits Of Being In The Study?
We hope that creatine and one-on-one clinical attention will benefit you and that your depression will improve. There may also be benefits to society, called “indirect benefits.” The study may help doctors understand depression in methamphetamine users so future patients will receive better treatment.
This study may help doctors understand if creatine is more effective for female methamphetamine users with depression compared to no treatment.
You will have your brain scanned twice in the study; these brain scans may help doctors understand how methamphetamine affects the brain and if taking creatine results in any brain changes.
What Do I Have To Do If I Am In The Study?
If you are interested in participating in the study, we will schedule an appointment for you to meet our study staff. You will undergo a screening visit to determine if you are eligible to participate. We will ask you some questions and draw your blood to make sure you are healthy and fit our criteria.
If you are eligible and decide that you want to be in the study, you will receive your first brain scan. You will also start taking the study drug each day. You will come to study visits twice a week for eight weeks where we will keep track of your use and labs.
At the end of eight weeks you will receive your second brain scan and will stop taking the study drug. After not taking study drug for two weeks, you will come in for your final appointment to make sure your labs are normal.
What If I Am On Probation? Will Any of my Information or Drug Screens Be Available For My Probation Officer?
No. We have a certificate of confidentiality from the federal government. All of your records about this research study will be kept locked up so only the researchers can see them. All the information we collect about you will be kept in a locked cabinet, or on computers that are protected by passwords.
What Do I Do If I Want More Information About The Study?
Please don't hesitate to contact us at 801-587-1549.
383 Colorow Drive
Salt Lake City, Utah 84108