DukeHealth.org: Duke Clinical Trials

Smoking and Decision-Making

Tue, 15 May 2012 10:30:59 -0400

Right-handed cigarette smokers are needed for a research study. Healthy, drug-free participants between the ages of 18 and 55 will be scheduled for two study visits. Both visits last about 2 hours and during the second visit participants will undergo an MRI scan. Compensation is $125 to $135.
No experimental medications involved.

Healthy Volunteers Needed for Research Study

Tue, 08 May 2012 10:45:24 -0400

The Duke Clinical Research Unit is looking for healthy volunteers to participate in a research study to assess the safety and tolerability of an investigational drug being evaluated for the potential treatment of antibiotic-resistant infections.

Eligibility Requirements

To be eligible to participate in this study, men and women must be:

Between the ages of 18 and 45
Weigh between 88 and 220 pounds
Take no medications
Non-smoker
Able to do overnight visits

Time Commitment

Two outpatient appointments and one three-night admission to the Duke Clinical Research Unit

Compensation

Participants will be compensated up to $1,350.

Live for Life Smoking Cessation Study -- Duke Employees Only

Mon, 07 May 2012 16:06:42 -0400

What is the study about?

The Research Study for Tobacco Cessation is an evaluation of the tobacco cessation programs offered through LIVE FOR LIFE, Duke's employee wellness program.

The purpose of this study is to investigate the potential relationship between genes you have inherited and your response to treatment to help you quit smoking cigarettes. It will also be used to determine the potential cost-effectiveness of the treatments used for smoking cessation.

Who can join?

To enroll in this study, you must be:

Enrolled in one of Duke’s health plans
Not currently pregnant
Not planning to leave Duke in the next six months
Interested in joining the Tobacco Cessation Program

What will I do as part of the study?

If the physician or physician assistant approves your participation, you will be asked to set a target quit-smoking date approximately five weeks out.

The study visit with LIVE FOR LIFE will take place as soon as possible after your screening visit. At this visit you will be given 21mg nicotine patches to apply daily for the next four weeks.

You will receive phone calls or e-mails from us weekly after you start using the nicotine patch. The last of these contacts will take place the day before your scheduled quit day.

Based on your response to the nicotine patches, you may be given the option to start taking Zyban with the nicotine patch or switch to Chantix. If the study physician feels that it is medically acceptable for you to take either Zyban or Chantix (based on information collected at the screening visit), you will be given the choice of which drug you prefer to take for the next 12 weeks. You will also select a new quit date for one week later.

Six months after your quit-smoking date you will be contacted by LIVE FOR LIFE staff to ask about your current smoking status. A saliva collection kit and instructions will also be sent to you in the mail.

What’s in it for me?

You will be reimbursed up to $150 for your participation in this study.

Another possible benefit from participation in this study is that you may quit smoking based on our recommendation about treatment. We hope the information learned from this study will benefit smokers in the future.

Who is conducting the study?

The principal investigator is Jed Rose, PhD, a professor in the Department of Psychiatry at Duke, and the director of the Duke Center for Nicotine and Smoking Cessation Research.

Information and Registration

Effects of Cigarette Mentholation on Brain Nicotine Accumulation During Smoking

Tue, 01 May 2012 10:26:13 -0400

The purpose of this study is to examine the rate that nicotine accumulates in your brain when smoking a menthol cigarette compared to a non-menthol cigarette.

This study consists of one physical screen and five study sessions over a three- to four-week period.

Physical Exam

The physical exam will take approximately two to two-and-a-half hours and includes a drug screen. If you test positive for illegal drugs, you will not be eligible to participate.

Study Sessions

If the physical screen confirms you are a good match for this study, you will be asked to return to the center for five study sessions.

The study sessions will involve the following types of visits:

Smoking evaluation sessions
Positron emission tomography (PET) sessions

Smoking Evaluation Sessions

There will be three smoking evaluation sessions -- each lasting approximately one-and-a-half to two hours. During these sessions, you may be asked to smoke one of your own cigarettes shortly after arriving for your visit. Your blood pressure, heart rate, and the CO (carbon monoxide) in your exhaled breath will be measured.

You will also smoke cigarettes through a smoking device that records information about your smoking habits and be asked to fill out questionnaires. At the end of the first session, you will be given study cigarettes to smoke for the next week or so.

You will also be asked to smoke several puffs of a cigarette from a smoking delivery system that controls how much smoke you inhale. This will be the same device you smoke from at the PET sessions.

PET Sessions

There will also be two positron emission tomography (PET) sessions -- each lasting approximately two to two-and-a-half hours.

PET scans are used to show chemical and functional changes within your body. During these scans, you will be asked to lie on an imaging table and remain still for about 45 minutes while the images are being taken.

Blood samples will be taken to measure the amount of nicotine and cotinine (a byproduct of nicotine) in your blood. Your blood pressure, heart rate, and the CO in your exhaled breath will also be measured.

Compensation

Your entire participation in this study will last approximately three to four weeks. If you complete all study visits and study requirements, you will be compensated up to $300. You will receive a check in the mail after you complete study participation. Please allow four to six weeks for your payment to be processed.

For further information or to find out if you qualify, please call 1-888-525-DUKE (888-525-3853) or e-mail smoking@duke.edu.

Hepatitis C Research Study -- BMS AI444-052

Fri, 20 Apr 2012 11:20:25 -0400

Duke University Medical Center is conducting a research study to compare how well the hepatitis C virus (HCV RNA) is decreased with the investigational drug, BMS-790052, combined with pegylated interferon-alfa 2a (pegIFNα) and ribavirin (RBV) compared to telaprevir (TVR) combined with pegylated interferon-alfa 2a (pegIFNα) and ribavirin (RBV), in patients with chronic hepatitis-C virus who have not been treated before.

Eligibility

To participate in this study, you must be an adult at least 18 years old who:

Has the chronic hepatitis C genotype 1
Has screening laboratory values, tests, and physical exam within acceptable ranges

Duration

If you take part in the study, your participation could last for approximately 72 weeks(about one-and-a-half years).

This will include a screening phase, a study drug period that could last up to 48 weeks, and a follow-up period that may last up until 72 weeks after your first dose of study drug.

Hepatitis C Research Study -- Gilead (GS-US-334-0107)

Fri, 20 Apr 2012 11:12:46 -0400

Duke University Medical Center is conducting a study to determine if GS-7977 in combination with ribavirin for 12 weeks is safe and able to eliminate the HCV infection from the body.

Eligibility Criteria

To participate in this study, you must be an adult who meets the following criteria:

Has hepatitis C genotype 2 or 3
Screening laboratory values, test, and physical exam within acceptable ranges

Duration

Your participation could last for approximately 42 weeks.

Hepatitis C Research Study -- Vertex (VX11-222-106)

Fri, 20 Apr 2012 11:02:31 -0400

Duke University Medical Center is conducting a research study to learn more about the safety and effects of the combination of VX-222, telaprevir, Peg-IFN, and RBV in people with chronic hepatitis C and cirrhosis.

Eligibility

To participate in this study, you must be an adult between the ages of 18 and 70 who has:

The chronic hepatitis C genotype 1 and cirrhosis
Screening laboratory values, tests, and physical exam within acceptable ranges

Duration

If you take part, you may be in the study for up to 100 weeks, or about two years. This will include a screening period of up to four weeks, a study treatment period of up to 48 weeks, and a follow-up period of up to 48 weeks.

Healthy Males Needed for a Research Study

Tue, 10 Apr 2012 10:46:54 -0400

The Duke Clinical Research Unit (DCRU) is looking for healthy males to participate in a research study to assess the effects of pretreatment with an investigational drug on the acute inflammatory response after endotoxin challenge.

Eligibility Requirements

Must be between ages 18 and 40
Weigh between 121 and 209 lbs.
Take no medications
Be a non-smoker
Able to do overnight visits

Compensation up to $3,925 for participation.

Alzheimer's Disease Study

Thu, 05 Apr 2012 16:03:06 -0400

The Duke Clinical Research Unit (DCRU) is looking for adults to participate in a research study to evaluate the safety and tolerability of an investigational drug for the treatment of Alzheimer's disease with mild cognitive impairment.

Eligible Participants must

Be age 50 or older
Have a diagnosis of mild Alzheimer's disease
Have frequent contact with a friend or spouse who is willing to attend all outpatient visits and can be involved as a project partner

Study Requirements

Seven outpatient visits and one admission
Physical exam
Cognitive assessments
Routine clinical laboratory tests
MRI at screening visit and final visit

Compensation

Participants will be compensated up to $1800

Project partners will be compensated up to $650

Hepatitis C and Human Immunodeficiency Virus type 1 (HIV) Research Study -- Vertex (VX-950-115)

Thu, 05 Apr 2012 15:52:33 -0400

Duke University Medical Center is conducting a research study to learn more about the safety and effects of the combination of telaprevir, peginterferon alfa-2a (Peg-IFN) and ribavirin (RBV) in subjects with chronic hepatitis C (HCV) and human immunodeficiency virus (HIV).

Eligibility Criteria

To participate in this study, you must be an adult between the ages of 18 and 70 who meets the following criteria:

Chronic hepatitis C genotype 1 and HIV
Screening laboratory values, tests, and physical exam within acceptable ranges

Duration

If you take part in the study, your participation could last for approximately 124 weeks (about two-and-a-third years). This will include a screening period that could last up to 28 days, a treatment period that could last up to 48 weeks, and a follow-up period that could last up to 24 weeks.

CREATE: Cognitive Remediation after Trauma Exposure

Thu, 05 Apr 2012 09:21:06 -0400

Have you suffered from a traumatic brain injury or post-traumatic stress disorder (PTSD)? Are you having ongoing cognitive problems? Are you 18-55 years of age?

If so, you might be eligible to participate in a research study at Duke University that examines the effectiveness of two FDA-approved medications in reducing cognitive symptoms.

Eligible subjects can earn up to $425 for participation in this 15-week study.

Dal-Outcomes 2

Tue, 27 Mar 2012 16:17:49 -0400

This study will test an investigational new drug called dalcetrapib in patients who are considered to be at elevated risk to experience an event, such as a heart attack or a stroke, from cardiovascular disease in the future.

The word “investigational” means the study drug is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

Dalcetrapib has been shown to increase HDL cholesterol in previous studies. If dalcetrapib increases the HDL cholesterol in patients who are considered at risk for cardiovascular disease, then it is thought that these patients would be less likely to have a cardiovascular event such as a heart attack, stroke, or peripheral arterial disease.

Eligibility Requirements

To be eligible to participate in this trial, participants must meet the following requirements:

Male and female patients older than 45 years of age with stable coronary heart disease (CHD), CHD risk equivalents, or at elevated risk for CHD
Have one of the following:

Stable coronary heart disease (CHD)
Prior ischemic stroke (more than three months prior to randomization)
Carotid artery stenosis greater than 50 percent on prior angiography or ultrasound
Prior documentation of peripheral artery disease
Patients with pharmacologically treated type 2 diabetes and one or more additional risk factor for CHD

Agree to have all study procedures performed
Competent and willing to provide written, informed consent to participate in this clinical study

Study of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Adolescents and Adults with Fragile X Syndrome

Thu, 22 Mar 2012 10:00:12 -0400

This is a 20-week research study of adolescents and adults who have been diagnosed with fragile X syndrome and are socially impaired.

The purpose of this study is to evaluate if the investigational drug STX209 is effective in managing symptoms associated with fragile X syndrome as well as if STX209 is safe and able to be tolerated. Participants will receive either active medication or placebo (sugar) pills.

Eligibility Requirements

To be eligible for this study, participants must:

Be between the ages of 12 and 50 years
Have fragile X syndrome
Have difficulties with social reactions or being around others
Not have any other significant medical conditions (e.g. heart disease, high blood pressure, lung disease, liver or kidney failure, unstable seizure disorder, thyroid disease)

Contact Lens Challenge Study

Wed, 21 Mar 2012 16:10:31 -0400

This study is looking to compare the normal swelling response of a contact lens in corneas of people who have undergone cornea transplantation to those who have not.

People who have not undergone a cornea transplant and who are over the age of 50 are asked to participate.

You will have an OCT photo taken to get a baseline thickness. An OCT photo is a low-level infrared light that takes cross sectional images (pictures like slides) of your cornea. No contact with the eye is made.

You will then be provided with a single-use contact lens to wear for two hours. Your cornea will swell slightly from wearing the contact lens (this is a normal response).

OCT photos will be taken every 20 minutes after the removal of the contact lens until your cornea returns to its normal thickness (average of about 3 hours).

This is a one time study visit.

You will receive a $50 Target gift card as a result of your participation.

Hepatitis C Study -- FISSION Study (P7977-1231)

Thu, 15 Mar 2012 16:25:09 -0400

Duke University Medical Center is conducting a study to help determine if the investigational drug PSI-7977 in combination with ribavirin for 12 weeks is safe and able to eliminate the HCV infection from your body. The word “investigational” means the study drug, PSI-7977, is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

Eligibility Criteria

To participate in this study, you must be an adult who meets the following criteria:

Chronic hepatitis C, genotype 3
Screening laboratory values, test, and physical exam within acceptable ranges

Duration

The study drug phase will last 12 or 24 weeks, depending on your which group you are assigned.

After you stop taking the study drug, you will return for follow up visits. This follow up phase will last 24 weeks after your last dose of study drug.