Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)

Smoking Clinical Trial

Official title:

Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326781
• Other study ID #: 703294
• Secondary ID: P50CA084718
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2006
• Last updated: August 16, 2010
• Start date: December 1999
• Est. completion date: August 2004

Study information

• Verified date: March 2010
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to:

1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and

2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).

Description:

The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of smokers: those with genotypes associated with less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with higher levels of novelty-seeking, depression, and attention deficit symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The subjects will be male and female smokers age 18-75.

• Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

• Planning a pregnancy, pregnant, or lactating

• Current addiction to opiates, cocaine, or stimulants

• Skin allergies or chronic dermatitis (based on medical history/self-report)

• An Axis 1 major psychiatric disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Nicoderm Transdermal Patch
The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.
• Nicotine Nasal Spray
8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (12)

Colilla S, Lerman C, Shields PG, Jepson C, Rukstalis M, Berlin J, DeMichele A, Bunin G, Strom BL, Rebbeck TR. Association of catechol-O-methyltransferase with smoking cessation in two independent studies of women. Pharmacogenet Genomics. 2005 Jun;15(6):39 — View Citation

Dahl JP, Jepson C, Levenson R, Wileyto EP, Patterson F, Berrettini WH, Lerman C. Interaction between variation in the D2 dopamine receptor (DRD2) and the neuronal calcium sensor-1 (FREQ) genes in predicting response to nicotine replacement therapy for tob — View Citation

Lerman C, Caporaso N, Main D, Audrain J, Boyd NR, Bowman ED, Shields PG. Depression and self-medication with nicotine: the modifying influence of the dopamine D4 receptor gene. Health Psychol. 1998 Jan;17(1):56-62. — View Citation

Lerman C, Jepson C, Wileyto EP, Epstein LH, Rukstalis M, Patterson F, Kaufmann V, Restine S, Hawk L, Niaura R, Berrettini W. Role of functional genetic variation in the dopamine D2 receptor (DRD2) in response to bupropion and nicotine replacement therapy — View Citation

Lerman C, Kaufmann V, Rukstalis M, Patterson F, Perkins K, Audrain-McGovern J, Benowitz N. Individualizing nicotine replacement therapy for the treatment of tobacco dependence: a randomized trial. Ann Intern Med. 2004 Mar 16;140(6):426-33. — View Citation

Lerman C, Wileyto EP, Patterson F, Rukstalis M, Audrain-McGovern J, Restine S, Shields PG, Kaufmann V, Redden D, Benowitz N, Berrettini WH. The functional mu opioid receptor (OPRM1) Asn40Asp variant predicts short-term response to nicotine replacement the — View Citation

Malaiyandi V, Lerman C, Benowitz NL, Jepson C, Patterson F, Tyndale RF. Impact of CYP2A6 genotype on pretreatment smoking behaviour and nicotine levels from and usage of nicotine replacement therapy. Mol Psychiatry. 2006 Apr;11(4):400-9. — View Citation

Munafò MR, Johnstone EC, Wileyto EP, Shields PG, Elliot KM, Lerman C. Lack of association of 5-HTTLPR genotype with smoking cessation in a nicotine replacement therapy randomized trial. Cancer Epidemiol Biomarkers Prev. 2006 Feb;15(2):398-400. — View Citation

Patterson F, Jepson C, Kaufmann V, Rukstalis M, Audrain-McGovern J, Kucharski S, Lerman C. Predictors of attendance in a randomized clinical trial of nicotine replacement therapy with behavioral counseling. Drug Alcohol Depend. 2003 Nov 24;72(2):123-31. E — View Citation

Rukstalis M, Jepson C, Patterson F, Lerman C. Increases in hyperactive-impulsive symptoms predict relapse among smokers in nicotine replacement therapy. J Subst Abuse Treat. 2005 Jun;28(4):297-304. — View Citation

Strasser AA, Kaufmann V, Jepson C, Perkins KA, Pickworth WB, Wileyto EP, Rukstalis M, Audrain-McGovern J, Lerman C. Effects of different nicotine replacement therapies on postcessation psychological responses. Addict Behav. 2005 Jan;30(1):9-17. — View Citation

Strasser AA, Pickworth WB, Patterson F, Lerman C. Smoking topography predicts abstinence following treatment with nicotine replacement therapy. Cancer Epidemiol Biomarkers Prev. 2004 Nov;13(11 Pt 1):1800-4. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)	A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).	End of Treatment (8-weeks after quit date)	No
Secondary	Verified 7-day Point Prevalence Abstinence at End Of Treatment.	End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.; This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey.	End of Treatment	No