Phase 2
N=87
Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00956943 ↗Enrolled (actual)
87
Serious AEs
1.2%
Results posted
Mar 2013
Primary outcome: Primary: Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment — 10; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nicoderm CQ transdermal nicotine (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment |
10; 13 | — |
| SECONDARY Side Effects |
0; 1 | — |
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 to transdermal nicotine patches, the most popular nicotine dependence treatment, and it affects plasma levels of nicotine from treatment. These studies suggest that fast metabolizers of nicotine may show better quit rates if they receive higher doses of transdermal nicotine. This preliminary study is designed to assess, for the first time, whether fast nicotine metabolizers show higher quit rates if given high dose transdermal nicotine, versus standard dose. The study findings may help to support a subsequent large trial to assess standard versus high dose transdermal nicotine for slow versus fast metabolizers of nicotine, which may lead to a more personalized approach to treating nicotine dependence using the nicotine patch to improve therapeutic benefits of transdermal nicotine.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00956943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.