Disclaimer: This approach to treatment is still under active investigation to confirm it is safe for patients and effective when used in conjunction with other approved therapies. We strongly discourage use of nicotine in any form, including tobacco smoking, smokeless tobacco, and patches, unless you have been advised by your physician to use it. While nicotine therapy is commonly used to help people quit smoking, it has not been proven to be safe and effective as a therapy for patients living with sarcoidosis. Please contact the study coordinators if you have questions about the study and always discuss any treatment decisions, including use of alternative therapies, with your doctor.
FSR is committed to informing patients and their loved ones about emerging therapies and research surrounding this disease. This includes sharing the outcomes of trials such as this which is understandably of great interest to our community. This particular trial is estimated to be completed in October 2019.
The main purpose of this study is to investigate if treatment with Habitrol Nicotine patches is beneficial for the treatment of sarcoidosis.
This is a placebo-controlled study. Patients who are selected for the trial will be randomly assigned to one of two groups, the control group and experimental group. Those research participants in the control group will receive placebo patches for 7 months, a treatment designed to have no real effect on their condition. Those participants in the experimental group will receive treatment with Habitrol Nicotine patches for the same time period.
Both groups will be contacted weekly by phone for the first 3 weeks then monthly for the duration of the study to monitor for any side effects. The following information and samples will be collected:
- Medical History
- Spirometry, a common test used to assess how well your lungs work by measuring how much air you inhale, how much you exhale and how quickly you exhale.
- CT Scans, a diagnostic medical test that, like traditional x-rays, produces multiple images or pictures of the inside of the body.
- Physical Exam
- Blood Samples for nicotine and nicotine metabolites
Criteria that may make you able to participate in this trial include:
- Adult male and female patients ≥ 18 to ≤ 75 years of age will be screened for eligibility.
- Eligible adult patients will have “active lung disease” that causes at least some shortness of breath, as determined by the expert opinion of doctors running the trial.
- Doses of these medications must be stable for at least 1 month before study entry.
- During the study, background medication regimen and doses are to remain stable.
Criteria that may not allow for you to participate include:
- active tobacco smoking or use of smokeless tobacco products containing nicotine,
- active cardiac or central nervous system disease,
- history of adverse reaction to nicotine or nicotine-containing products,
- patients currently being treated with remicade and/or Humira,
- inability to provide consent.
The subject will be excluded if they have a smoking history of greater than 20 pack years, or a diagnosis of other significant respiratory disorder other, than sarcoidosis that, in the opinion of the investigator, would complicate the evaluation of response to treatment; or, history of substance abuse (drugs or alcohol) within 3 years prior to screening or other circumstances (e.g., psychiatric disease) that could interfere with the subject’s adherence to protocol requirements or increase their risk of drug (nicotine) dependence.
- Columbus, Ohio, USA – Ohio State University
- Cleveland, Ohio, USA – Cleveland Clinic
To learn more, view the full trial information on clinicaltrials.gov or contact:
- Karen Martin
- Emily Robart
Choosing to participate in a study is an important decision we encourage you to discuss with your physicians, family members, and friends. Every study comes with potential risks and benefits you should discuss thoroughly with you physicians and study coordinators.