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Medisorb Naltrexone study

Aurora Behavioral Health Services, in conjunction with the Center for Addiction and Behavioral Health Research, is currently conducting a study for individuals experiencing problems with alcohol usage. 

There are a number of ways to help people with alcohol problems. The Medisorb Naltrexone study is designed to test the effectiveness and safety of an injectable form of the drug naltrexone. Naltrexone is a medication that orally has been shown to help people with alcohol problems.

Tell me more about the naltrexone medication

Naltrexone, in the pill form, is FDA-approved and is used in the treatment of alcohol dependence. Naltrexone has been reported to reduce both craving and the reinforcing euphoric (high) qualities of alcohol. Given to alcohol dependent patients, it has been shown to reduce the tendency to heavy drinking, reduce the number of drinking days, and reduce the total amount of alcohol consumed.

What does Medisorb Naltrexone mean? 

Naltrexone alone is currently available in a daily pill form. Medisorb Naltrexone however is an injectable, extended-release drug delivery technology that allows once-a-month dosing of naltrexone. The Medisorb Naltrexone drug delivery technology is designed to enhance compliance with the naltrexone medication by removing the need for taking pills everyday. In addition, the Medisorb Naltrexone drug delivery system provides therapeutic drug levels consistently over a one-month period, which is unlike oral medication drug levels that tend to fluctuate in your body.

As a participant in this study, you may receive: Medisorb Naltrexone 190 mg or Medisorb Naltrexone 380 mg or Placebo (inactive medication) for Medisorb Naltrexone 190 mg or 350 mg. You will not know if you are receiving the real medication or the placebo, however 2 out of 3 participants will receive the active medication.

What are the injections like and how many will I receive?

Trained professionals will administer the injections, and they will use special needles that have been designed to reduce discomfort. As a participant in this study you will receive an injection into the muscle of your buttocks once every 4 weeks over a 24-week (or 6-month) period for a total of 6 injections.

Is counseling also a part of this study?

Yes. Regardless of whether you receive active medication or placebo, all Medisorb Naltrexone participants will receive the BRENDA intervention. The BRENDA intervention is a six-stage model designed to help facilitate recovery for people with alcohol dependence. The BRENDA model provides direct feedback and advice to participants about their biological, psychological, and social status with respect to addiction related consequences.

What is my part in the study?

Assessment

When you come in to learn about the study, the risks and benefits of participating will be explained to you. Before you are accepted for participation in the study, you will be interviewed, complete some paper and pencil questionnaires, undergo some lab tests, and receive a brief medical exam. If you are not eligible for the Medisorb Naltrexone study, other treatment options will be explained to you.

The study is not appropriate for persons under 18 or for women who are pregnant, breastfeeding or thinking about becoming pregnant.

Treatment 

Participants will randomly be assigned to one of the four different conditions. All participants will meet regularly with a medical professional such as a nurse or doctor.

How often will I have to come for appointments? 

Initially you will visit the Clinical Research Unit every week for the first 4 weeks. Visits will then gradually decrease to every other week and then finally to once a month. During the months in which you will be visiting the Clinical Research Unit only once, you will also have regular telephone contact with study staff.

Will I have to pay for my treatment? 

No, there is no charge for any assessment, medication, treatment, or lab tests that you receive as part of the Medisorb Naltrexone study.

Is the program confidential? 

We will do everything possible to keep all records confidential. We cannot absolutely assure confidentiality. You will be assigned a confidential code number so your name will not be associated with information given or identified anywhere in the research results. Research files will be kept separate from your hospital medical records.

What are my responsibilities? 

You are expected to keep your appointments on time and to be free from alcohol during your visits to the Clinical Research Unit. If you are unable to attend a session, you should let the study staff know at least 24 hours in advance. For more information regarding the study, please call 414-219-3509.