Analyzing milestones in smoking cessation: illustration in a nicotine patch trial in adult smokers.

Tests of addiction treatments seldom reveal where treatment exercises its effect (i.e., promoting initial abstinence, preventing lapses, and/or impeding progression from lapse to relapse). The authors illustrate analyses distinguishing effects on these milestones in a randomized trial of high-dose nicotine patch (35 mg; n = 188) versus placebo (n = 136) in adult smokers, who used electronic diaries to monitor smoking in real time during 5 weeks of treatment. High-dose patch promoted initial abstinence (hazard ratio [HR] = 1.3) and decreased the risk of lapsing among those who achieved abstinence (HR = 1.6). The biggest effect of treatment was to prevent progression to relapse among those who had lapsed (HR = 7.1). Analysis of effects by milestones may enhance understanding of cessation treatments and their mechanisms of action.

[1]  L. Cox,et al.  Effects of transdermal nicotine patches on abstinence-induced and cue-elicited craving in cigarette smokers. , 2000, Journal of consulting and clinical psychology.

[2]  R. Perera,et al.  Nicotine replacement therapy for smoking cessation. , 2012, The Cochrane database of systematic reviews.

[3]  C. Lerman,et al.  Applying genetic approaches to the treatment of nicotine dependence , 2002, Oncogene.

[4]  Y. Chien,et al.  The nicotine transdermal system. , 1998, Clinics in dermatology.

[5]  R. Holman,et al.  Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) , 1998, The Lancet.

[6]  R. Bain,et al.  Predictors of Progression From Impaired Glucose Tolerance to NIDDM: An Analysis of Six Prospective Studies , 1997, Diabetes.

[7]  John M. Lachin,et al.  Biostatistical Methods: The Assessment of Relative Risks , 2000 .

[8]  McGinnis Jm,et al.  Actual causes of death in the United States. , 1993 .

[9]  B. Howard,et al.  Effects of Diet and Exercise in Preventing NIDDM in People With Impaired Glucose Tolerance: The Da Qing IGT and Diabetes Study , 1997, Diabetes Care.

[10]  N. Mello,et al.  Testing for abuse liability of drugs in humans. Proceedings of a conference. November 5-6, 1988, Princeton, NJ. , 1989, NIDA research monograph.

[11]  D J Rohsenow,et al.  Relevance of cue reactivity to understanding alcohol and smoking relapse. , 1988, Journal of abnormal psychology.

[12]  E. Fisher,et al.  The Diabetes Prevention Program: recruitment methods and results. , 2002, Controlled clinical trials.

[13]  R. Walton,et al.  Level of nicotine replacement during a quit-smoking attempt. , 2004, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[14]  Elizabeth J. Mayer-Davis,et al.  Validity and reproducibility of a food frequency interview in a Multi-Cultural Epidemiology Study. , 1999, Annals of epidemiology.

[15]  J. L. Dahl,et al.  Trends in medical use and abuse of opioid analgesics. , 2000, JAMA.

[16]  T. Thorsen,et al.  Screening and brief intervention targeting risky drinkers in Danish general practice--a pragmatic controlled trial. , 2007, Alcohol and alcoholism.

[17]  S S Smith,et al.  Predicting smoking cessation. Who will quit with and without the nicotine patch. , 1994, JAMA.

[18]  C. Caspersen,et al.  Introduction to a Collection of Physical Activity Questionnaires , 1997 .

[19]  Nora D Volkow,et al.  Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. , 2003, The American journal of psychiatry.

[20]  Bruce D. Meyer Unemployment Insurance and Unemployment Spells , 1988 .

[21]  B. Steele,et al.  The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. , 1996, The New England journal of medicine.

[22]  J M Lachin,et al.  Implementation of group sequential logrank tests in a maximum duration trial. , 1990, Biometrics.

[23]  J. Wess,et al.  Deletion of the M5 muscarinic acetylcholine receptor attenuates morphine reinforcement and withdrawal but not morphine analgesia , 2002, Proceedings of the National Academy of Sciences of the United States of America.

[24]  C. Hancock,et al.  OxyContin Use and Abuse. , 2002, Clinical journal of oncology nursing.

[25]  K. Flegal,et al.  Prevalence of Diabetes, Impaired Fasting Glucose, and Impaired Glucose Tolerance in U.S. Adults: The Third National Health and Nutrition Examination Survey, 1988–1994 , 1998, Diabetes Care.

[26]  M. Fiore,et al.  The effectiveness of the nicotine patch for smoking cessation. A meta-analysis. , 1994, JAMA.

[27]  R. C. Nelson,et al.  The impact of the addition of naloxone on the use and abuse of pentazocine. , 1987, Public health reports.

[28]  R. Gillum,et al.  Diabetes mellitus, coronary heart disease incidence, and death from all causes in African American and European American women: The NHANES I epidemiologic follow-up study. , 2000, Journal of clinical epidemiology.

[29]  S. Shiffman,et al.  Ecological Momentary Assessment (Ema) in Behavioral Medicine , 1994 .

[30]  C. Lerman,et al.  Treating tobacco dependence: state of the science and new directions. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[31]  J. Gerberding,et al.  Actual causes of death in the United States, 2000. , 2004, JAMA.

[32]  K. Narayan,et al.  Preventing Non-Insulin-Dependent Diabetes , 1995, Diabetes.

[33]  S. Shiffman,et al.  Progression from a smoking lapse to relapse: prediction from abstinence violation effects, nicotine dependence, and lapse characteristics. , 1996, Journal of consulting and clinical psychology.

[34]  J. Zacny,et al.  Characterizing the subjective, psychomotor, and physiological effects of oral oxycodone in non-drug-abusing volunteers , 2003, Psychopharmacology.

[35]  G. Ainslie Picoeconomics: The Strategic Interaction of Successive Motivational States within the Person , 1992 .

[36]  P. Diggle,et al.  Analysis of Longitudinal Data , 2003 .

[37]  D. Abrams,et al.  Matching High-Dependence and Low-Dependence Smokers to Self-Help Treatment with or Without Nicotine Replacement , 1994 .

[38]  M. Walton,et al.  The role of attributions in abstinence, lapse, and relapse following substance abuse treatment. , 1994, Addictive behaviors.

[39]  S. Fortmann,et al.  Nicotine patch and self-help video for cigarette smoking cessation. , 1997, Journal of consulting and clinical psychology.

[40]  S. Shiffman,et al.  A pharmacokinetic crossover study to compare the absorption characteristics of three transdermal nicotine patches , 2000, Pharmacology Biochemistry and Behavior.

[41]  Cindy Farquhar,et al.  3 The Cochrane Library , 1996 .

[42]  J. Wilson‐Barnett,et al.  A survey of chronic noncancer pain patients prescribed opioid analgesics. , 2003, Pain medicine.

[43]  S Shiffman,et al.  A day at a time: predicting smoking lapse from daily urge. , 1997, Journal of abnormal psychology.

[44]  T. Valle,et al.  Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. , 2001, The New England journal of medicine.

[45]  A. Rice,et al.  Cannabinoids and pain. , 2007, Handbook of experimental pharmacology.

[46]  R. DeFronzo Pharmacologic Therapy for Type 2 Diabetes Mellitus , 1999, Annals of Internal Medicine.

[47]  Recent developments in the pharmacotherapy of substance abuse. , 1996 .

[48]  T. Kosten,et al.  Therapeutic vaccines for substance dependence , 2002, Expert review of vaccines.

[49]  K. Foley,et al.  College on Problems of Drug Dependence taskforce on prescription opioid non-medical use and abuse: position statement. , 2003, Drug and alcohol dependence.

[50]  D. Ossip-Klein,et al.  Task Force 1: Classification and assessment of smoking behavior. , 1986 .

[51]  B. Rosner,et al.  Predictors of smoking relapse among self-quitters: a report from the Normative Aging Study. , 1992, Addictive behaviors.

[52]  Ronald C. Kessler,et al.  Comparative epidemiology of dependence on tobacco, alcohol, controlled substances, and inhalants: Basic findings from the National Comorbidity Survey. , 1994 .

[53]  S. Heishman,et al.  The addictive role of nicotine in tobacco use , 2005, Psychopharmacology.

[54]  M. Harris,et al.  Early detection of undiagnosed diabetes mellitus: a US perspective , 2000, Diabetes/metabolism research and reviews.

[55]  S. Shiffman,et al.  Efficacy of acute administration of nicotine gum in relief of cue-provoked cigarette craving , 2003, Psychopharmacology.

[56]  R. Forman Availability of opioids on the Internet. , 2003, JAMA.

[57]  G. Marlatt,et al.  Abstinence violation effect: validation of an attributional construct with smoking cessation. , 1987, Journal of consulting and clinical psychology.

[58]  J. Volpicelli,et al.  Naltrexone in the treatment of alcoholism: predicting response to naltrexone. , 1995, The Journal of clinical psychiatry.

[59]  K. Malterud,et al.  Screening and brief intervention for excessive alcohol use: qualitative interview study of the experiences of general practitioners , 2002, BMJ : British Medical Journal.

[60]  Richard A. Brown,et al.  Symptoms of depression and survival experience among three samples of smokers trying to quit. , 2001 .

[61]  N. Benowitz,et al.  Dose‐related cardiovascular and endocrine effects of transdermal nicotine , 1998, Clinical pharmacology and therapeutics.

[62]  P. Lehert,et al.  Does Acamprosate Improve Reduction of Drinking As Well As Aiding Abstinence? , 2003, Journal of psychopharmacology.

[63]  O. Gureje,et al.  Persistent pain and well-being: a World Health Organization Study in Primary Care. , 1998, JAMA.

[64]  Y. Shaham,et al.  Reinstatement and spontaneous recovery of nicotine seeking in rats , 1997, Psychopharmacology.

[65]  S. Shiffman,et al.  First lapses to smoking: within-subjects analysis of real-time reports. , 1996, Journal of consulting and clinical psychology.

[66]  Richard A. Brown,et al.  The Tobacco Dependence Treatment Handbook: A Guide to Best Practices. By D. B. Abrams, R. , 2004 .

[67]  R. J. Rose,et al.  Behavioral Monitoring and Urine Toxicology Testing in Patients Receiving Long-Term Opioid Therapy , 2003, Anesthesia and analgesia.

[68]  K. Emmons,et al.  Relapse and maintenance issues for smoking cessation. , 2000, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[69]  Robyn L Richmond,et al.  Measures of abstinence in clinical trials: issues and recommendations. , 2003, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[70]  J. Zacny Characterizing the subjective, psychomotor, and physiological effects of a hydrocodone combination product (Hycodan) in non-drug-abusing volunteers , 2002, Psychopharmacology.

[71]  Gail K. Strickler,et al.  Risk factors associated with problem use of prescription drugs. , 2004, American Journal of Public Health.

[72]  D. Fishbain,et al.  Drug Abuse, Dependence, and Addiction in Chronic Pain Patients , 1992, The Clinical journal of pain.

[73]  Dominique M. Hanssens,et al.  Long-run abstinence after narcotics abuse: What are the odds? , 1998 .

[74]  S. Sutton Great expectations: some suggestions for applying the balanced placebo design to nicotine and smoking. , 1991, British journal of addiction.

[75]  R. Hanson,et al.  The 1997 American Diabetes Association and 1999 World Health Organization criteria for hyperglycemia in the diagnosis and prediction of diabetes. , 2000, Diabetes care.

[76]  Mc Fiore,et al.  Treating Tobacco Use and Dependence , 2000 .

[77]  J. Rose,et al.  Acute effects of nicotine and mecamylamine on tobacco withdrawal symptoms, cigarette reward and ad lib smoking , 2001, Pharmacology, Biochemistry and Behavior.

[78]  J. Hughes Pharmacotherapy for smoking cessation: unvalidated assumptions, anomalies, and suggestions for future research. , 1993, Journal of consulting and clinical psychology.

[79]  S Shiffman,et al.  Dynamic effects of self-efficacy on smoking lapse and relapse. , 2000, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[80]  Andrew J Waters,et al.  Cue-provoked craving and nicotine replacement therapy in smoking cessation. , 2004, Journal of consulting and clinical psychology.

[81]  Robert G Carlson,et al.  Probable relationship between opioid abuse and heroin use. , 2003, American family physician.

[82]  C. Bogardus,et al.  Changing habits to delay diabetes. , 2001, The New England journal of medicine.

[83]  K. Dodge,et al.  Social-cognitive processes of severely violent, moderately aggressive, and nonaggressive boys. , 1994, Journal of consulting and clinical psychology.