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

NCT00326781 | Completed Phase 4 Results

• 2 other identifiers: 703294P50CA084718
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to:

1. 1.compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and
2. 2.identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).

Conditions

Smoking

Keywords

Nicotine nasal spray + counseling; Transdermal nicotine + counseling

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Verified 7-day Point Prevalence Abstinence at End Of Treatment.

  End of Treatment

Study Arms (2)

Nicotine Nasal Spray

ACTIVE COMPARATOR

Drug: Nicotine Nasal Spray

Transdermal Nicotine patch

ACTIVE COMPARATOR

Drug: Nicoderm Transdermal Patch

Interventions

Nicoderm Transdermal Patch DRUG

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.

Also known as: Nicoderm®

Transdermal Nicotine patch

Nicotine Nasal Spray DRUG

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.

Also known as: Nicotrol

Nicotine Nasal Spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects will be male and female smokers age 18-75.
• Eligible smokers will be those currently smoking at least 10 cigarettes a day.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (14)

• Munafo 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. doi: 10.1158/1055-9965.EPI-05-0648. No abstract available.

  PMID: 16492936 RESULT

• 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. doi: 10.1038/sj.mp.4001794.

  PMID: 16402128 RESULT

• 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 tobacco dependence. Pharmacogenomics J. 2006 May-Jun;6(3):194-9. doi: 10.1038/sj.tpj.6500358.

  PMID: 16402081 RESULT

• 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 for tobacco dependence: results of two randomized clinical trials. Neuropsychopharmacology. 2006 Jan;31(1):231-42. doi: 10.1038/sj.npp.1300861.

  PMID: 16123753 RESULT

• 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. doi: 10.1016/j.jsat.2005.02.002.

  PMID: 15925263 RESULT

• 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):393-8. doi: 10.1097/01213011-200506000-00004.

  PMID: 15900212 RESULT

• 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. doi: 10.1016/j.addbeh.2004.04.005.

  PMID: 15561445 RESULT

• 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.

  PMID: 15533910 RESULT

• 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. doi: 10.7326/0003-4819-140-6-200403160-00009.

  PMID: 15023708 RESULT

• 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 therapy in a clinical trial. Pharmacogenomics J. 2004;4(3):184-92. doi: 10.1038/sj.tpj.6500238.

  PMID: 15007373 RESULT

• 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. doi: 10.1016/s0376-8716(03)00194-7.

  PMID: 14636967 RESULT

• 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. doi: 10.1037//0278-6133.17.1.56.

  PMID: 9459071 RESULT

• Ashare RL, Wileyto EP, Perkins KA, Schnoll RA. The first 7 days of a quit attempt predicts relapse: validation of a measure for screening medications for nicotine dependence. J Addict Med. 2013 Jul-Aug;7(4):249-54. doi: 10.1097/ADM.0b013e31829363e1.

  PMID: 23669629 DERIVED

• Javitz HS, Lerman C, Swan GE. Comparative dynamics of four smoking withdrawal symptom scales. Addiction. 2012 Aug;107(8):1501-11. doi: 10.1111/j.1360-0443.2012.03838.x. Epub 2012 Apr 17.

  PMID: 22321019 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Nicotine; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Results Point of Contact

• Title: Caryn Lerman, Ph.D.
• Organization: University of Pennsylvania

clerman@mail.med.upenn.edu

215-746-7141

Study Officials

• Caryn Lerman, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2006
• First Posted: May 17, 2006
• Study Start: December 1, 1999
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: August 24, 2010
• Results First Posted: March 19, 2010

Record last verified: 2010-03

Locations

US (1)