Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain

Lori A Bastian, Mary Driscoll, Eric DeRycke, Sara Edmond, Kristin Mattocks, Joe Goulet, Robert D Kerns, Mark Lawless, Caroline Quon, Kim Selander, Jennifer Snow, Jose Casares, Megan Lee, Cynthia Brandt, Joseph Ditre, William Becker, Lori A Bastian, Mary Driscoll, Eric DeRycke, Sara Edmond, Kristin Mattocks, Joe Goulet, Robert D Kerns, Mark Lawless, Caroline Quon, Kim Selander, Jennifer Snow, Jose Casares, Megan Lee, Cynthia Brandt, Joseph Ditre, William Becker

Abstract

Introduction: Smoking is associated with greater pain intensity and pain-related functional interference in people with chronic pain. Interventions that teach smokers with chronic pain how to apply adaptive coping strategies to promote both smoking cessation and pain self-management may be effective.

Methods: The Pain and Smoking Study (PASS) is a randomized clinical trial of a telephone-delivered, cognitive behavioral intervention among Veterans with chronic pain who smoke cigarettes. PASS participants are randomized to a standard telephone counseling intervention that includes five sessions focusing on motivational interviewing, craving and relapse management, rewards, and nicotine replacement therapy versus the same components with the addition of a cognitive behavioral intervention for pain management. Participants are assessed at baseline, 6, and 12 months. The primary outcome is smoking cessation.

Results: The 371 participants are 88% male, a median age of 60 years old (range 24-82), and smoke a median of 15 cigarettes per day. Participants are mainly white (61%), unemployed (70%), 33% had a high school degree or less, and report their overall health as "Fair" (40%) to "Poor" (11%). Overall, pain was moderately high (mean pain intensity in past week = 5.2 (Standard Deviation (SD) = 1.6) and mean pain interference = 5.5 (SD = 2.2)). Pain-related anxiety was high (mean = 47.0 (SD = 22.2)) and self-efficacy was low (mean = 3.8 (SD = 1.6)).

Conclusions: PASS utilizes an innovative smoking and pain intervention to promote smoking cessation among Veterans with chronic pain. Baseline characteristics reflect a socioeconomically vulnerable population with a high burden of mental health comorbidities.

Keywords: Cognitive behavioral treatment; Pain; Proactive recruitment; Smoking cessation; Tobacco.

Figures

Fig. 1
Fig. 1
CONSORT diagram for pain and smoking study.

References

    1. Goldberg M.S., Scott S.C., Mayo N.E. A review of the association between cigarette smoking and the development of nonspecific back pain and related outcomes. Spine (Phila Pa 1976) 2000;25(8):995–1014.
    1. John U., Hanke M., Meyer C., Völzke H., Baumeister S.E., Alte D. Tobacco smoking in relation to pain in a national general population survey. Prev. Med. 2006;43(6):477–481.
    1. John U., Alte D., Hanke M., Meyer C., Völzke H., Schumann A. Tobacco smoking in relation to analgesic drug use in a national adult population sample. Drug Alcohol Depend. 2006;85(1):49–55.
    1. Shiri R., Karppinen J., Leino-Arjas P., Solovieva S., Viikari-Juntura E. The association between smoking and low back pain: a meta-analysis. Am. J. Med. 2010;123(1) 87.e87-35.
    1. Shiri R., Falah-Hassani K. The effect of smoking on the risk of sciatica: a meta analysis. Am. J. Med. 2016;129(1):64–73. e20.
    1. Sugiyama D., Nishimura K., Tamaki K. Impact of smoking as a risk factor for developing rheumatoid arthritis: a meta-analysis of observational studies. Ann. Rheum. Dis. 2010;69(1):70–81.
    1. Wolkenstein P., Revuz J., Roujeau J.C. Psoriasis in France and associated risk factors: results of a case-control study based on a large community survey. Dermatology. 2009;218(2):103–109.
    1. Waldie K.E., McGee R., Reeder A.I., Poulton R. Associations between frequent headaches, persistent smoking, and attempts to quit. Headache. 2008;48(4):545–552.
    1. Zvolensky M.J., McMillan K., Gonzalez A., Asmundson G.J. Chronic pain and cigarette smoking and nicotine dependence among a representative sample of adults. Nicotine Tob. Res. 2009;11(12):1407–1414.
    1. Ditre J.W., Brandon T.H. Pain as a motivator of smoking: effects of pain induction on smoking urge and behavior. J. Abnorm. Psychol. 2008;117(2):467–472.
    1. Ditre J.W., Brandon T.H., Zale E.L., Meagher M.M. Pain, nicotine, and smoking: research findings and mechanistic considerations. Psychol. Bull. 2011;137(6):1065–1093.
    1. Ditre J.W., Zale E.L., LaRowe L.R. A reciprocal model of pain and substance use: transdiagnostic considerations, clinical implications, and future directions. Annu. Rev. Clin. Psychol. 2019;15(1):503–528.
    1. LaRowe L.R., Ditre J.W. Pain, nicotine, and tobacco smoking: current state of the science. Pain. 2020;161(8):16881693. doi: 10.1097/j.pain.0000000000001874.
    1. Ditre J.W., Heckman B.W., Butts E.A., Brandon T.H. Effects of expectancies and coping on pain-induced motivation to smoke. J. Abnorm. Psychol. 2010;119(3):524–533.
    1. Parkerson H.A., Asmundson G.J.G. The role of pain intensity and smoking expectancieson smoking urge and behavior following experimental pain induction. Drug Alcohol Depend. 2016;164:166–171.
    1. Bakhshaie J., Ditre J.W., Langdon K.J., Asmundson G.J., Paulus D.J., Zvolensky M.J. Pain intensity and smoking behavior among treatment seeking smokers. Psychiatr. Res. 2016;237:67–71.
    1. De Vita M.J., Maisto S.A., Ansell E.B., Zale E.L., Ditre J.W. Pack-years of tobacco cigarette smoking as a predictor of spontaneous pain reporting and experimental pain reactivity. Exp. Clin. Psychopharmacol. 2019;27(6):552–560.
    1. Pisinger C., Aadahl M., Toft U., Birke H., Zytphen-Adeler J., Jørgensen T. The association between active and passive smoking and frequent pain in a general population. Eur. J. Pain. 2011;15(1):77–83.
    1. Weingarten T.N., Podduturu V.R., Hooten W.M., Thompson J.M., Luedtke C.A., Oh T.H. Impact of tobacco use in patients presenting to a multidisciplinary outpatient treatment program for fibromyalgia. Clin. J. Pain. 2009;25(1):39–43.
    1. Odani S., Agaku I.T., Graffunder C.M., Tynan M.A., Armour B.S. Tobacco product use among military veterans — United States, 2010–2015. MMWR Morb. Mortal. Wkly. Rep. 2018;67:7–12. doi: 10.15585/mmwr.mm6701a2.
    1. Volkman J.E., DeRycke E.C., Driscoll M.A. Smoking status and pain intensity among OEF/OIF/OND veterans. Pain Med. 2015;16:1690–1696.
    1. Critchley J.A., Capewell S. Mortality risk reduction associated with smoking cessation in patients with coronary heart disease: a systematic review. J. Am. Med. Assoc. 2003;290(1):86–97.
    1. Critchley J., Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst. Rev. 2004;1:CD003041.
    1. Lerman C., Patterson F., Berrettini W. Treating tobacco dependence: state of the science and new directions. J. Clin. Oncol. 2005;23(2):311–323.
    1. Hooten W.M., Shi Y., Gazelka H.M., Warner D.O. The effects of depression and smoking on pain severity and opioid use in patients with chronic pain. Pain. 2011;152(1):223–229.
    1. Orhurhu V.J., Pittelkow T.P., Hooten W.M. Prevalence of smoking in adults with chronic pain. Tob. Induc. Dis. 2015;13:17.
    1. Behrend C., Prasarn M., Coyne E., Horodyski M., Wright J., Rechtine G.R. Smoking cessation related to improved patient-reported pain scores following spinal care. J Bone Joint Surg Am. 2012;94(23):2161–2166.
    1. Zale E.L., Ditre J.W., Dorfman M.L., Heckman B.W., Brandon T.H. Smokers in pain report lower confidence and greater difficulty quitting. Nicotine Tob. Res. 2014;16(9):1272–1276.
    1. Ditre J.W., Heckman B.W., LaRowe L.R., Powers J.M. Pain status as a predictor of smoking cessation initiation, lapse, and relapse. Nicotine Tob. Res. 2020;23(1):186–194. doi: 10.1093/ntr/ntaa111.
    1. Ditre J.W., Zale E.L., Kosiba J.D., Zvolensky M.J. A pilot study of pain-related anxiety and smoking-dependence motives among persons with chronic pain. Exp. Clin. Psychopharmacol. 2013;21(6):443–449.
    1. Ocañez K.L., McHugh R.K., Otto M.W. A meta-analytic review of the association between anxiety sensitivity and pain. Depress. Anxiety. 2010;27(8):760–767.
    1. LaRowe L.R., Zvolensky M.J., Ditre J.W. The role of anxiety-relevant transdiagnostic factors in comorbid chronic pain and tobacco cigarette smoking. Cognit. Ther. Res. 2019;43(1):102–113.
    1. Hooten W.M., Townsend C.O., Bruce B.K., Warner D.O. The effects of smoking status on opioid tapering among patients with chronic pain. Anesth. Analg. 2009;108(1):308–315.
    1. Patterson A.L., Gritzner S., Resnick M.P., Dobscha S.K., Turk D.C., Morasco B.J. Smoking cigarettes as a coping strategy for chronic pain is associated with greater pain intensity and poorer pain-related function. J. Pain. 2012;13(3):285–292.
    1. LaRowe L.R., Rother Y., Powers J.M., Zvolensky M.J., Vanable P.A., Ditre J.W. Pain self-efficacy, race, and motivation to quit smoking among persons living with HIV (PLWH) Addict. Behav. 2020;105:106318.
    1. Hooten W.M., Townsend C.O., Hays J.T. A cognitive behavioral smoking abstinence intervention for adults with chronic pain: a randomized controlled pilot trial. Addict. Behav. 2014;39(3):593–599.
    1. Driscoll M.A., Perez E., Edmond S.N. A brief, integrated, telephone-based intervention for veterans who smoke and have chronic pain: a feasibility study. Pain Med. 2018;19(suppl_1):S84–s92.
    1. Ditre J.W., LaRowe L.R., Vanable P.A., De Vita M.J., Zvolensky M.J. Computer-based personalized feedback intervention for cigarette smoking and prescription analgesic misuse among persons living with HIV (PLWH) Behav. Res. Ther. 2019;115:83–89.
    1. Zale E.L., Maisto S.A., De Vita M.J., Hooten W.M., Ditre J.W. Advance online publication; 2020. Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain: A Pilot Randomized Controlled Trial. Experimental and Clinical Psychopharmacology.
    1. Tzelepis F., Paul C.L., Walsh R.A., McElduff P., Knight J. Proactive telephone counseling for smoking cessation: meta-analyses by recruitment channel and methodological quality. J. Natl. Cancer Inst. 2011;103:922–941.
    1. Saragiotto B.T., Kamper S.J., Hodder R., Silva P.V., Wolfenden L., Lee H., Oliveira V.C., Robson E., Wiggers J., Williams C.M. Interventions targeting smoking cessation for patients with chronic pain: an evidence synthesis. Nicotine Tob. Res. 2018;22:135–140.
    1. Dworkin R.H., Turk D.C., Wyrwich K.W., Beaton D. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J. Pain. 2008;9:105–121.
    1. Bandura A. Prentice Hall, Inc.; Englewood Cliffs, NJ: 1985. Social Foundations of Thought and Action: A Social Cognitive Theory.
    1. Miller W.R., Rollnick S. Guilford Press; New York, NY: 1991. Motivational Interviewing: Preparing People to Change Addictive Behavior.
    1. Bastian L.A., Fish L.J., Gierisch J.M., Rohrer L.D., Stechuchak K.M., Sc G. Comparative effectiveness trial of family-supported smoking cessation intervention versus standard telephone counseling for chronically ill veterans using proactive recruitment. Comp. Effect. Res. 2012;2:45–56.
    1. VHA Pharmacy Benefits Management Services Recommendations for use of combination therapy in tobacco use cessation April 2009.
    1. Bars M.P., Banauch G.I., Appel D. Tobacco free with FDNY": the New York city fire department world trade center tobacco cessation study. Chest. 2006;129:979–987.
    1. Stewart M.O., Karlin B.E., Murphy J.L., Raffa S.D., Miller S.A., McKellar J., Kerns R.D. National dissemination of cognitive behavioral therapy for chronic pain in veterans: therapist and patient-level outcomes. Clin. J. Pain. 2015;31:722–729.
    1. Murphy J, McKellar J, Raffa S, Clark M, Kerns R, Karlin B. Cognitive Behavioral Therapy for Chronic Pain Among Veterans: Therapist Manual, Washington, DC.
    1. Hughes J.R., Keely J.P., Niaura R.S., Ossip-Klein D.J., Richmond R.L., Swan G.E. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob. Res. 2003;5(1):13–25.
    1. Tan G., Jensen M.P., Thornby J.I., Shanti B.F. Validation of the brief pain inventory for chronic nonmalignant pain. J. Pain. 2004;5(2):133‐137. doi: 10.1016/j.jpain.2003.12.005.
    1. DoVAo Defense. 2010. VA/DOD Clinical Practice Guideline for Management of Opioid Therapy for Chonic Pain.
    1. Cleeland C.S., Schall M., Nolan K., Reyes-Gibby C.C., Paice J., Rosenberg J.M., Tollett J.H., Kerns R.D. Rapid improvement in pain management: the veterans health administration and the Institute for healthcare improvement collaborative. Clin. J. Pain. 2003;19:298–305.
    1. Murray D.M., McBride C., Lindquist R., Belcher J.D. Sensitivity and specificity of saliva thiocyanate and cotinine for cigarette smoking: a comparison of two collection methods. Addict. Behav. 1991;16:161–166.
    1. Pomerleau C.S., Carton S.M., Lutzke M.L., Flessland K.A., Pomerleau O.F. Reliability of the fagerstrom tolerance questionnaire and the fagerstrom test for nicotine dependence. Addict. Behav. 1994;19(1):33.
    1. Ware J., Kosinski M., Keller S.D. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med. Care. 1996;34(3):220–233.
    1. Kroenke K., Spitzer R.L., Williams J.B. The PHQ-9: validity of a brief depression severity measure. J. Gen. Intern. Med. 2001;16(9):606‐613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Bush K., Kivlahan D.R., McDonell M.B., Fihn S.D., Bradley K.A. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch. Intern. Med. 1998;158(16):1789‐1795. doi: 10.1001/archinte.158.16.1789.
    1. Shiffman S., Balabanis M.H., Paty J.A., Engberg J., Gwaltney C.J., Liu K. Dynamic effects of self-efficacy on smoking lapse and relapse. Health Psychol. 2000;19:315–323.
    1. Baer J.S., Holt C.S., Lichtenstein E. Self-efficacy and smoking reexamined: construct validity and clinical utility. J. Consult. Clin. Psychol. 1986;54:846–852.
    1. McCracken L.M., Dhingra L. A short version of the Pain Anxiety Symptoms Scale (PASS-20): preliminary development and validity. Pain Res. Manag. 2002;7(1):45–50.
    1. Hosmer D.W., Lemeshow S. second ed. John Wiley & Sons,Inc.; New York: 1989. Applied Logistic Regression.
    1. Committee for Proprietary Medicinal Products (CPMP): points to consider on adjustment for baseline covariates. Stat. Med. 2004;23(5):701–709.
    1. Zeger K.Y., Liang S.L. An overview of methods for the analysis of longitudinal data. Stat. Med. 1992;11:1825–1839.
    1. Fitzmaurice G.M.L.N., Ware J.H. Wiley-Interscience; Hoboken, NJ: 2004. Applied Longitudinal Analysis.
    1. Kraemer H.C., Wilson G.T., Fairburn C.G., Agras W.S. Mediators and moderators of treatment effects in randomized clinical trials. Arch. Gen. Psychiatr. 2002;59:877–883.
    1. Kraemer H.C., Kiernan M., Essex M., Kupfer D.J. How and why criteria defining moderators and mediators differ between the Baron & Kenny and MacArthur approaches. Health Psychol. 2008;27(2):S101–S108.
    1. Gilbert H.M., Sutton S.R., Leurent B., Alexis-Garsee C., Morris R.W., Nazareth I. Characteristics of a population-wide sample of smokers recruited proactively for the ESCAPE trial. Publ. Health. 2012 Apr;126(4):308–316.
    1. Rogers E.S., Fu S.S., Krebs P., Noorbaloochi S., Nugent S.M., Gravely A., Sherman S.E. Proactive tobacco treatment for smokers using veterans administration mental health clinics. Am. J. Prev. Med. 2018;54(5):620–629.
    1. Bastian L.A., Fish L.J., Peterson B.L., Biddle A.K., Garst J., Lyna P., Molner S., Bepler G., Kelley M., Keefe F.J., McBride C.M. Proactive recruitment of cancer patients' social networks into a smoking cessation trial. Contemp. Clin. Trials. 2011 Jul;32(4):498–504.
    1. Heapy A.A., Higgins D.M., LaChappelle K.M. Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC Muscoskel. Disord. 2016;17(1):85.
    1. Employment Situation of Veterans. U.S. Bureau of Labor Statistics; 2020. [press release]
    1. Hanson D., Woods T. The Urban Institute; November 2016. The State of Post-9/11 Veteran Families.
    1. Bastian L.A., Fish L.J., Gierisch J.M., Stechuchak K.M., Grambow S.C., Keefe F.J. Impact of smoking cessation on subsequent pain intensity among chronically ill veterans enrolled in a smoking cessation trial. J. Pain Symptom Manag. 2015;50(6):822–829.
    1. Liu Y., Collins C., Wang K., Xie X., Bie R. The prevalence and trend of depression among veterans in the United States. J. Affect. Disord. 2019;245:724–727.
    1. Gierisch J.M., Bastian L.A., Calhoun P.S., McDuffie J.R., Williams J.W., Jr. Comparative Effectiveness of Smoking Cessation Treatments for Patients with Depression: A Systematic Review and Meta-Analysis of the Evidence. Department of Veterans Affairs (US); Washington (DC): 2010. VA evidence-based synthesis program reports.
    1. Cody G.R., Wang B., Link A.R., Sherman S.E. Characteristics of urban inpatient smokers with and without chronic pain: foundations for targeted cessation programs. Subst. Use Misuse. 2019;54(7):1138–1145.
    1. Zale E.L., Maisto S.A., Ditre J.W. Anxiety and depression in bidirectional relations between pain and smoking: implications for smoking cessation. Behav. Modif. 2016;40:7–28. doi: 10.1177/0145445515610744.
    1. Seal K.H., Cohen G., Waldrop A., Cohen B.E., Maguen S., Ren L. Substance use disorders in Iraq and Afghanistan veterans in VA healthcare, 2001-2010: implications for screening, diagnosis and treatment. Drug Alcohol Depend. 2011;116(1–3):93–101.
    1. Zale E.L., Maisto S.A., Ditre J.W. Interrelations between pain and alcohol: an integrative review. Clin. Psychol. Rev. 2015;37:57–71.
    1. Moskal D., Maisto S.A., De Vita M., Ditre J.W. Effects of experimental pain induction on alcohol urge, intention to consume alcohol, and alcohol demand. Exp. Clin. Psychopharmacol. 2018;26(1):65–76. doi: 10.1037/pha0000170.
    1. Aigner C.J., Gritz E.R., Tamí-Maury I., Baum G.P., Arduino R.C., Vidrine D.J. The role of pain in quitting among human immunodeficiency virus (HIV)-positive smokers enrolled in a smoking cessation trial. Subst. Abuse. 2017;38(3):249–252.
    1. Powers J.M., LaRowe L.R., Heckman B.W., Ditre J.W. Pain characteristics and nicotine deprivation as predictors of performance during a laboratory paradigm of smoking cessation. Psychol. Addict. Behav. 2020;34(2):341–350.
    1. Abrams M.P., Carleton R.N., Asmundson G.J.G. An exploration of the psychometric properties of the PASS-20 with a nonclinical sample. J. Pain. 2007 Nov;8(11):879–886.
    1. Ni K., Wang B., Link A.R., Sherman S.E. Does smoking intensity predict cessation rates? A study of light-intermittent, light-daily, and heavy smokers enrolled in two telephone-based counseling interventions. Nicotine Tob. Res. 2020;22(3):423–430.
    1. Danan E.R., Joseph A.M., Sherman S.E. Does motivation matter? Analysis of a randomized trial of proactive outreach to VA smokers. J. Gen. Intern. Med. 2016;31(8):878–887.
    1. Sherman S.E., Krebs P., York L.S. Telephone care coordination for tobacco cessation: randomised trials testing proactive versus reactive models. Tobac. Contr. 2018;27(1):78–82.
    1. Danan E.R., Fu S.S., Clothier B.A. The equity impact of proactive outreach to smokers: analysis of a randomized trial. Am. J. Prev. Med. 2018;55(4):506–516.
    1. Barnett P.G., Ignacio R.V., Kim H.M. Cost-effectiveness of real-world administration of tobacco pharmacotherapy in the United States Veterans Health Administration. Addiction. 2019;114(8):1436–1445.
    1. Ditre J.W., Heckman B.W., Zale E.L., Kosiba J.D., Maisto S.A. Acute analgesic effects of nicotine and tobacco in humans: a meta-analysis. Pain. 2016;157(7):1373–1381.
    1. Adams J.M. Smoking cessation—progress, barriers, and new opportunities: the Surgeon General's report on smoking cessation. J. Am. Med. Assoc. 2020;323(24):2470–2471.
    1. Bagdas D., Alkhlaif Y., Jackson A., Carroll F.I., Ditre J.W., Damaj M.I. New insights on the effects of varenicline on nicotine reward, withdrawal and hyperalgesia in mice. Neuropharmacology. 2018;138:72–79.
    1. Adams Jm. U.S. Department of Health and Human Services Smoking Cessation . HHS; 2020. A Report of the Surgeon General.
    1. Garcia-Rodriguez O., Secades-Villa R., Florez-Salamanca L. Probability and predictors of relapse to smoking: results of the national epidemiologic survey on alcohol and related conditions (NESARC) Drug Alcohol Depend. 2013;132:479–485.
    1. The Community Guide Reducing tobacco use and secondhand smoke exposure: comprehensive tobacco control programs—task force finding and rationale statement. September. 2014;29 accessed.
    1. Whittaker R., McRobbie H., Bullen C., Borland R., Rodgers A., Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst. Rev. 2012;(Issue 11) Art. No.: CD006611.
    1. Lancaster T., Stead L.F. Individual behavioural counselling for smoking cessation. Cochrane Database Syst. Rev. 2017;(Issue 3) Art. No.: CD001292.

Source: PubMed

Подписаться