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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Metabolism Informed Smoking Treatment for Smoking Cessation in Medicaid and Medicare Patients

This phase III trial compares the effect of a metabolism informed smoking treatment (MIST) to standard therapy to help Medicaid and Medicare patients quit smoking. Quitting smoking can help prevent smoking-related diseases like cancer and heart disease and can help patients live longer. MIST includes a free screening blood test to show how fast the body breaks down nicotine in order to help people quit smoking. The screening test is the first step to a study that may help doctors choose the best medication to quit smoking.
Miscellaneous
Phase III
Adults
Not Available
Not Available
Tindle, Hilary
Local
Vanderbilt University
11-11-2020
Treatment
VICCTHO2046
NCT04590404

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

18 years old or older

Be enrolled in or pending approval for an insurance plan that supports prescription coverage for smoking cessation medication (including Medicare part D, Medicaid, private insurance, Federal or other governmental, or other insurance) to facilitate bedside delivery of medications prior to hospital discharge

Have a regular provider/PCP to prescribe smoking cessation medication; if patient does not have a PCP, the study team may collaborate with the patient to establish a primary care provider

Agree to quit or try to quit smoking upon hospital discharge

Be a daily smoker when smoking normally during the month prior to entering the hospital

Be medically eligible to use varenicline * Medical eligibility to take varenicline is defined by absence of the following: ** Serious brain condition that impairs cognition (including but not limited to dementia, delirium, brain tumors/metastases, uncontrolled seizures [i.e., seizures within the past 3 months [mo.]) ** Pregnancy/planning to become pregnant/breastfeeding in the next year ** History of allergic reaction to varenicline ** Unstable/uncontrolled mental health condition: *** Altered mental status (e.g., delirium, hallucinations) OR *** Serious psychiatric symptoms in the past 6 months as defined by suicidal ideation or attempt, hospitalization or emergency department (ED) visit involving a psychiatric condition (e.g., depression, anxiety, bipolar, schizophrenia, schizoaffective disorder, post-traumatic stress disorder (PTSD), substance use (e.g., overdose), other related) OR *** Changes in psychiatric medication within the past 3 months ** If alcohol use; history of blackouts or seizures with drinking

Be medically eligible to use nicotine replacement therapy * Medical eligibility to use nicotine replacement therapy is defined by absence of the following: ** Unstable from cardiovascular perspective for hospital discharge ** Current or history of Buergers disease (also called thromboangiitis obliterans) ** Pregnant/planning to become pregnant/breastfeeding in the next year

Have received medication recommendations from a tobacco counselor

Agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it

Have a cell phone or landline that can be reached directly (i.e., without transfer)

Have a permanent address where they live and can receive mail



Exclusion Criteria:

Insufficient time to perform and complete the enrollment process

Barrier to effective communication (including low English proficiency)

Not cognitively able to participate in the study

Too ill, on hospice, or physically unable to participate in the follow-up process

Previously completed the MIST study or is currently enrolled in a quit smoking study that involves a medication-based treatment

To learn more about any of our clinical
trials, call 615-936-8422.