Smoking Clinical Trial
Official title:
Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy - Transdisciplinary Tobacco Use Research Center (TTURC), Project 2
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 |
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Cancer Institute (NCI) |
United States,
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
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 |
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