Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine

NCT00956943 | Completed Phase 2 Results

• 2 other identifiers: 809716R21DA026889
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Nicotine Dependence

Keywords

nicotine dependence; nicotine replacement therapy; transdermal nicotine; nicotine metabolism; high dose

Outcome Measures

Primary Outcomes (1)

• Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment

  quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)

  After 8 weeks of treatment with the patch, outcome will be measured.

Secondary Outcomes (1)

• Side Effects

  8 weeks

Study Arms (2)

21mg transdermal nicotine + placebo patch

ACTIVE COMPARATOR

21mg transdermal nicotine + placebo patch

Drug: Nicoderm CQ transdermal nicotine; Drug: placebo

42mg transdermal nicotine

EXPERIMENTAL

42mg transdermal nicotine

Drug: Nicoderm CQ transdermal nicotine

Interventions

Nicoderm CQ transdermal nicotine DRUG

Transdermal nicotine patch (21mg vs. 42mg), 8 weeks

21mg transdermal nicotine + placebo patch; 42mg transdermal nicotine

placebo DRUG

placebo patch

21mg transdermal nicotine + placebo patch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This was a proof of concept trial and, as such, was inadequately powered to detect statistically significant treatment arm effects and did not include a long-term follow-up assessment.

Results Point of Contact

• Title: Robert A. Schnoll, Ph.D.
• Organization: University of Pennsylvania

schnoll@mail.med.upenn.edu

215-746-7143

Study Officials

• Robert A Schnoll, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: August 11, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 15, 2014
• Results First Posted: March 18, 2013

Record last verified: 2014-08

Locations

US (1)