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Studies Needing Volunteers

Who Benefits from Medical Research?

You, your children, and your grandchildren benefit from medical research; we all do. You can help ensure a healthier tomorrow for you and your loved ones by participating in clinical trails available at the Minneapolis Medical Research Foundation. The following list gives details of some of the MMRF studies that are looking for volunteers. Check this list often as it is always changing!

 

Alcohol Dependence Study

Description: The Hennepin Faculty Associates Addiction Medicine Program is participating in clinical trials for the purpose of evaluating the safety and effectiveness of an investigational medication in promoting abstinence from alcohol during the treatment of alcohol dependence.

The orally administered form of the medication has been approved by the Food and Drug Administration (FDA). Taken daily, and combined with counseling, it has been shown to reduce craving, enhance abstinence and decrease relapse to heavy drinking.

The study medication, which is not yet approved by the FDA, is designed to replace daily oral dosing with monthly injections by using a time-release technology that is FDA-approved for use in other medications.

Qualified participants in the study will receive intramuscular (upper buttocks) injections of either the medication or a placebo (no active pharmaceutical ingredients) once a month over the course of 3 months. In addition, they will receive counseling, a physical exam, lab tests, and diagnostic work at no cost.

Candidates for the study will need to go through a screening process, but the general inclusion and exclusion criteria are as follows:

Criteria for Inclusion: To participate in the study, you must:

  • Be between the ages of 18 to 65
  • Have experienced recent heavy drinking and have the desire to stop
  • Be able to achieve at least 3 days in a row of sobriety without detoxification medications
  • Not be dependent on any drug of abuse (other than nicotine)
  • Be available to participate in the study for 3-1/2 months
  • Not be pregnant or nursing

Criteria for Exclusion: To participate in the study, you can't:

  • Currently be taking prescription medication(s)
    • to prevent alcohol consumption
    • neuroleptic medication
    • coumadin
  • Currently be in need of inpatient detoxification from alcohol
  • Be dependent on any drug of abuse other than nicotine
  • Currently be in court-mandated alcohol or drug abuse treatment or are awaiting legal proceedings which could result in incarceration during the study
  • Have a history of pancreatitis
  • Have chronic or episodic pain conditions which reasonably require opiate medications for pain control
  • Have any psychiatric or medical condition that would interfere with safe participation in the study procedures

For More Information: To inquire further about participating in this study, please call the HFA Addiction Medicine Program at (612) 347-3915.

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Angiogenesis Studies

Heart

Study Description: This study is a Phase IIa clinical trial evaluating the gene for VEGF-2 for safety and effectiveness. Vascular Endothelial Growth Factor (VEGF) is one of several growth hormones that are naturally produced in your body. These hormones are specific to your blood vessels and cause them to start the growth of tiny arteries, called collaterals, where blood flow is limited. For example, when the arteries that deliver blood to your heart muscle, called coronary arteries, are narrowed or blocked, your body will secrete growth factors, such as VEGF and FGF to grow new collaterals. These new arteries will deliver blood flow to the areas that are compromised. However, collaterals are much smaller than the major arteries in your heart and deliver smaller amounts of blood flow to the heart muscle. The gene for VEGF-2 is available only in clinical trials that are under the Federal Drug Administration's (FDA) supervision. The VEGF gene Phase II clinical trial is being done at about 4 hospitals in the United States. Patients must go through a screening process to evaluate if they qualify for the study (including treadmill exercise tests, cancer screening, and eye exams). Once it is determined that they qualify, patients sign a consent form and are enrolled into the clinical trial. The VEGF-2 gene is delivered to the heart by injection directly into the heart muscle during an open-heart surgery. Patients are followed for 12 months.

Criteria for Inclusion: To participate in the study, you must have:

  • Chest pain/Angina which interferes with quality of life
  • Abnormal nuclear perfusion scan
  • Abnormal coronary angiogram and not a good candidate for surgery or angioplasty

For More Information: Please call 612-347-2875.

Legs

Study Description: The study is an open-label, dose escalating, phase I clinical study of intramuscular gene therapy for FGF-1 in patients with severe peripheral artery occlusive disease. The study will assess the clinical effect of the treatment and safety of the gene encoding for Fibroblast Growth Factor (FGF-1) at escalating doses given by intramuscular injections into the affected leg. The study population is persons with Severe Peripheral Artery Occlusive Disease (PAOD) as defined by rest pain, non-healing ulcers or other evidence of tissue loss due to arterial insufficiency in the affected leg, and angiographic evidence of total occlusion in an artery of the affected leg. Subjects are followed for 6 months post-treatment assessments.

Entry Criteria

Inclusion:

  • Age greater than 18 years old
  • Severe peripheral artery occlusive disease with rest pain, non-healing ulcers or gangrene
  • Angiographic evidence of total occlusion
  • Not a candidate for percutaneous or surgical revascularization

Exclusion:

  • Malignancy: history of cancer
  • Renal dysfunction: Creatinine of > 1.8 mg/%
  • Proliferative Retinopathy
  • Lower extremity surgery, angioplasty within 2 months

For More Information: Please call 612-347-2875.

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Diabetes and Weight Loss

Weight Loss Study

Study Description: A 2-year research study that provides intensive nutrition and exercise counseling and the opportunity to take an investigational weight loss medication.

Inclusion Criteria: To participate in the study you must

  • Be 40+ lbs. overweight
  • Not be taking any medications for diabetes, high blood pressure, depression, or thyroid problems
  • Not be taking any prescription, herbal, or over-the-counter weight loss medications

For More Information: Please call the Hennepin Center for Diabetes and Metabolism Clinical Research line at 612-347-6814.

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Hepatitis C

3AR: Botanical Compound for Treatment of Hepatitis C.

Study Description: This NIH-sponsored study will examine whether a combination of traditional Chinese herbal medicines (3AR) improves symptoms and laboratory parameters in patients with chronic hepatitis C (HCV). HCV has emerged as a major public health issue in the United states. Current treatment regimens (based on interferons) lead to long-term remission in only a minority of patients.

This is a placebo-controlled, randomized, blinded study that will examine the short-term effectiveness of 3AR in patients with HCV. The treatment phase is 12 weeks, followed by two follow-up visits in the ensuing 8 weeks. Herbal medications, laboratory tests, and medical check ups will be provided at no cost.

Inclusion/exclusion criteria:

  • Confirmed HCV with a prior evaluation by a specialist
  • Abnormal ALT
  • Symptomatic fatigue that impacts on the patient's quality of life
  • No other major medical issues

For More Information: please call Jennifer 612-337-7378

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Sleep Study

Description: MMRF investigators at the Minnesota Regional Sleep Disorders Center are looking for women to participate in a study on the efficacy of Zolpidem in the treatment of insomnia in peri- and post-menopausal women. Study duration is 4 - 6 weeks. Participants could earn up to $300.

Inclusion Criteria: Women interested in participating should:

  • Be between 40 and 60 years old
  • Be peri- or post-menopausal for at least six months
  • Have difficulty maintaining sleep or have non-restorative sleep
  • Experience hot-flashes or night sweats that interfere with sleep
  • Be in good physical and mental health
  • Have no other sleep disorders

For More Information: Please call the Minnesota Regional Sleep Disorders Center at 612-347-4031.

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