Pharmacogenetics of Nicotine Addiction Treatment

Completed · Phase 3 · Has a placebo group

Conditions studied: Nicotine Addiction

In brief

The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.

Key facts

Study ID

NCT01314001

Run by

University of Pennsylvania

People needed

1246

Starts

2010-12-01

Expected to finish

2014-09-01

Last updated by the study team

2016-03-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible participants will be males and females
• Between the ages of 18-65.
• Smoke at least 10 cigarettes/day for the past 6 months.
• Provide a baseline Carbon Monoxide (CO) reading greater than 10ppm at the Intake Session.
• Are seeking smoking cessation treatment.
• Plan to live in the area for the next 12 months.
• Fluent English speaker.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and Health Insurance Portability and Accountability Act (HIPAA) form. All subjects must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, tubal ligation) or abstain from sexual intercourse during the time they are taking study medication (pills and patches) and for at least one month after the medication period ends. All female subjects of child-bearing potential should not be pregnant for the duration of the study.

You may not qualify if…

• Smoking Behavior
• Regular (daily) use of chewing tobacco, snuff or snus.
• Current enrollment or plans to enroll in another smoking cessation or research program in the next 12 months.
• Plan to use other nicotine substitutes or smoking cessation treatments in the next 12 months.
• Provide a baseline CO reading less than or equal to 10ppm at the Intake Session.
• Alcohol/Drug Exclusion Criteria
• History (within the last year) or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants), excluding nicotine.
• Current use of cocaine and/or methamphetamines (urine drug screen at the Intake Session).
• Current alcohol consumption that exceeds greater than 25 standard drinks/week.
• Current alcohol abuse or dependence.
• Current non-alcoholic psychoactive substance abuse or dependence.
• Medical Exclusion Criteria
• Women who are pregnant, planning a pregnancy, or lactating.
• History of epilepsy or a seizure disorder.
• Current medical problems for which transdermal nicotine is contraindicated including:
• Allergy to latex.
• History of kidney and/or liver disease, including transplant (self-report).
• Uncontrolled hypertension (determined as a Systolic Blood pressure (SBP) reading greater than 160 and/or a Diastolic Blood Pressure (DBP) greater than 100).
• Serious or unstable disease within the past 6 months.
• History (last 6 months) of abnormal heart rhythms, tachycardia and cardiovascular disease (stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case by case basis by the Study Physician.
• Inability to provide a blood sample to be used to assess nicotine metabolite ratio.
• Psychiatric Exclusion Criteria (as determined by self report \& MINI)
• Current diagnosis of major depression. Persons with a history of major depression, if stable for 6 months or longer, are eligible, provided they are not excluded based on medications (below).
• Any suicide risk score on MINI or self-reported suicide attempt on telephone screen.
• Current or past hypomanic/manic episode.

Where it is running

• University at Buffalo - State University of New York — Buffalo, New York, United States
• Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center, University of Texas — Houston, Texas, United States
• Centre for Addiction and Mental Health, University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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