Status:
COMPLETED
Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine
Lead Sponsor:
University of Pennsylvania
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
Unfortunately, the investigators still need to assess and identify novel ways to help people quit smoking. Differences between people in terms of how fast they metabolize nicotine influences response ...
Detailed Description
Novel approaches to treating nicotine dependence remain a priority. The transdermal nicotine patch is the most widely used form of tobacco dependence treatment, but only \~1 in 5 smokers who use this ...
Eligibility Criteria
Inclusion
- Males and females age 18-45 who smoke \> 10 cigarettes/ day;
- Able to communicate in English;
- Able to use NRT safely (e.g., no allergy to latex);
- Able to provide written informed consent for study procedures;
- Residing in the geographic area for at least 6 months; and
- A 3-HC/cotinine ratio in the top quartile of the distribution (Schnoll et al., 2008). Age 45 was selected as an upper limit to reduce the likelihood of adverse effects from high dose transdermal nicotine.
Exclusion
- History of substance abuse or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana);
- Current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week.
- Current use or discontinuation within last 14 days of:
- Smoking cessation medications (bupropion, Chantix, NRT);
- Antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants);
- Medication for pain;
- Anti-coagulants;
- Heart medications;
- Daily medication for asthma or diabetes.
- Women who are pregnant, planning a pregnancy, or lactating;
- History or current diagnosis of psychosis, major depression or bipolar disorder, psychotic disorder, or generalized anxiety disorder;
- Serious/unstable disease within the past 6 months (e.g., cancer \[but melanoma\], HIV/AIDS);
- History of epilepsy or seizure disorder;
- History or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (\>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina), heart attack in the last 6 months, uncontrolled hypertension (SBP\>150 or DBP\>90);
- History of kidney or liver failure.
- Any medical condition or medication that could compromise safety as determined by a study physician;
- Inability to provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00956943
Start Date
August 1 2009
End Date
August 1 2011
Last Update
August 15 2014
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104