Assessment of patient perception of treatment assignment and patient-reported outcomes in a cannabis use disorder trial

References

• Peterson C, Li M, Xu L, Mikosz CA, Luo F. Assessment of annual cost of substance use disorder in US hospitals. JAMA Netw Open. 2021;4:e210242. doi:10.1001/jamanetworkopen.2021.0242.
   PubMed Web of Science ®Google Scholar
• U.S. Department of Health and Human Services (HHS). Office of the surgeon general. facing addiction in America: the surgeon general’s report on alcohol, drugs, and health. Washington (DC): HHS; 2016.
   Google Scholar
• Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JAC, et al. The Cochrane collaboration’s tool for assessing risk of bias in randomised trials. Bmj. 2011;343:d5928. doi:10.1136/bmj.d5928.
   PubMed Web of Science ®Google Scholar
• Savovic J, Jones HE, Altman DG, Harris RJ, Juni P, Pildal J, Als-Nielsen B, Balk EM, Gluud C, Gluud LL, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012;157:429–38. doi:10.7326/0003-4819-157-6-201209180-00537.
   PubMed Web of Science ®Google Scholar
• Moustgaard H, Clayton GL, Jones HE, Boutron I, Jorgensen L, Laursen DRT, Olsen MF, Paludan-Müller A, Ravaud P, Savović J, et al. Impact of blinding on estimated treatment effects in randomised clinical trials: meta-epidemiological study. Bmj. 2020;368:l6802.
   PubMedGoogle Scholar
• Saltaji H, Armijo-Olivo S, Cummings GG, Amin M, da Costa BR, Flores-Mir C, da Costa BR. Influence of blinding on treatment effect size estimate in randomized controlled trials of oral health interventions. BMC Med Res Methodol. 2018;18:42. doi:10.1186/s12874-018-0491-0.
   PubMed Web of Science ®Google Scholar
• Armijo-Olivo S, Fuentes J, da Costa BR, Saltaji H, Ha C, Cummings GG, da Costa BR.Blinding in physical therapy trials and its association with treatment effects: a meta-epidemiological study. Am J Phys Med Rehabil. 2017;96:34–44. doi:10.1097/PHM.0000000000000521.
   PubMed Web of Science ®Google Scholar
• FDA. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. Silver Spring (MD): Food and Drug Administration; 2009.
   Google Scholar
• Kaptchuk TJ, Miller FG.Placebo effects in medicine. N Engl J Med. 2015;373:8–9. doi:10.1056/NEJMp1504023.
   PubMed Web of Science ®Google Scholar
• Roydhouse JK, Mishra-Kalyani PS, Bhatnagar V, Gutman R, King-Kallimanis BL, Sridhara R, Kluetz PG, et al. Does knowledge of treatment assignment affect patient report of symptoms, function, and health status? An evaluation using multiple myeloma trials. Value Health. 2021;24:822–29. doi:10.1016/j.jval.2020.12.015.
   PubMed Web of Science ®Google Scholar
• Haahr MT, Hrobjartsson A. Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors. Clin Trials. 2006;3:360–65. doi:10.1177/1740774506069153.
   PubMed Web of Science ®Google Scholar
• Bello S, Moustgaard H, Hrobjartsson A. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications. J Clin Epidemiol. 2014;67:1059–69. doi:10.1016/j.jclinepi.2014.05.007.
   PubMed Web of Science ®Google Scholar
• Bello S, Moustgaard H, Hrobjartsson A. Unreported formal assessment of unblinding occurred in 4 of 10 randomized clinical trials, unreported loss of blinding in 1 of 10 trials. J Clin Epidemiol. 2017;81:42–50. doi:10.1016/j.jclinepi.2016.08.002.
   PubMed Web of Science ®Google Scholar
• Atkinson TM, Wagner JS, Basch E. Trustworthiness of patient-reported outcomes in unblinded cancer clinical trials. JAMA Oncol. 2017;3:738–39. doi:10.1001/jamaoncol.2016.3328.
   PubMed Web of Science ®Google Scholar
• Oviedo-Joekes E, Marchand K, Palis H, Guh D, Brissette S, Lock K, MacDonald S, Harrison S, Anis AH, Krausz M, et al. Predictors of treatment allocation guesses in a randomized controlled trial testing double-blind injectable hydromorphone and diacetylmorphine for severe opioid use disorder. Addiction Res Theory. 2017;25:263–72. doi:10.1080/16066359.2016.1263729.
   Web of Science ®Google Scholar
• Howard J, Whittemore AS, Hoover J, Panos M, Amisr G. How blind was the patient blind in AMIS? Clin Pharmacol Ther. 1982;32:543–53. doi:10.1038/clpt.1982.201.
   PubMed Web of Science ®Google Scholar
• Boutron I, Estellat C, Ravaud P. A review of blinding in randomized controlled trials found results inconsistent and questionable. J Clin Epidemiol. 2005;58:1220–26. doi:10.1016/j.jclinepi.2005.04.006.
   PubMed Web of Science ®Google Scholar
• Dar R, Stronguin F, Etter JF. Assigned versus perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers. J Consult Clin Psychol. 2005;73:350–53. doi:10.1037/0022-006X.73.2.350.
   PubMed Web of Science ®Google Scholar
• Schnoll RA, Epstein L, Audrain J, Niaura R, Hawk L, Shields PG, Lerman C, Wileyto EP, et al. Can the blind see? Participant guess about treatment arm assignment may influence outcome in a clinical trial of bupropion for smoking cessation. J Subst Abuse Treat. 2008;34:234–41. doi:10.1016/j.jsat.2007.04.004.
   PubMed Web of Science ®Google Scholar
• Bailey SR, Fong DM, Bryson SW, Fortmann SP, Killen JD. Perceived drug assignment and treatment outcome in smokers given nicotine patch therapy. J Subst Abuse Treat. 2010;39:150–56. doi:10.1016/j.jsat.2010.05.013.
   PubMed Web of Science ®Google Scholar
• Colagiuri B, Morley K, Boakes R, Haber P. Expectancy in double-blind placebo-controlled trials: an example from alcohol dependence. Psychother Psychosom. 2009;78:167–71. doi:10.1159/000206871.
   PubMed Web of Science ®Google Scholar
• Hemilä H. Assessment of blinding may be inappropriate after the trial. Contemp Clin Trials. 2005;26:512–15. doi:10.1016/j.cct.2005.04.002.
   PubMed Web of Science ®Google Scholar
• Sackett DL. Commentary: measuring the success of blinding in RCTs: don’t, must, can’t or needn’t? Int J Epidemiol. 2007;36:664–65. doi:10.1093/ije/dym088.
   PubMed Web of Science ®Google Scholar
• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Bmj. 2010;340:c869. doi:10.1136/bmj.c869.
   PubMed Web of Science ®Google Scholar
• Monaghan TF, Agudelo CW, Rahman SN, Wein AJ, Lazar JM, and Everaert K, et al. Blinding in clinical trials: seeing the big picture. Medicina (Kaunas). 2021;57:647.
   Web of Science ®Google Scholar
• Kolahi J, Bang H, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol. 2009;37:477–84. doi:10.1111/j.1600-0528.2009.00494.x.
   PubMed Web of Science ®Google Scholar
• Rees JR, Wade TJ, Levy DA, Colford JM Jr., Hilton JF. Changes in beliefs identify unblinding in randomized controlled trials: a method to meet CONSORT guidelines. Contemp Clin Trials. 2005;26:25–37. doi:10.1016/j.cct.2004.11.020.
   PubMed Web of Science ®Google Scholar
• Laferton JAC, Vijapura S, Baer L, Clain AJ, Cooper A, Papakostas G, Price LH, Carpenter LL, Tyrka AR, Fava M, et al. Mechanisms of perceived treatment assignment and subsequent expectancy effects in a double blind placebo controlled RCT of major depression. Front Psychiatry. 2018;9:424.
   PubMed Web of Science ®Google Scholar
• Correa JB, Heckman BW, Marquinez NS, Drobes DJ, Unrod M, Roetzheim RG, Brandon TH, et al. Perceived medication assignment during a placebo-controlled laboratory study of varenicline: temporal associations of treatment expectancies with smoking-related outcomes. Psychopharmacology (Berl). 2014;231:2559–66. doi:10.1007/s00213-013-3420-2.
   PubMed Web of Science ®Google Scholar
• Gray KM, Sonne SC, McClure EA, Ghitza UE, Matthews AG, McRae-Clark AL, Carroll KM, Potter JS, Wiest K, Mooney LJ, et al. A randomized placebo-controlled trial of N-acetylcysteine for cannabis use disorder in adults. Drug Alcohol Depend. 2017;177:249–57.
   PubMed Web of Science ®Google Scholar
• McClure EA, Sonne SC, Winhusen T, Carroll KM, Ghitza UE, McRae-Clark AL, Matthews AG, Sharma G, Van Veldhuisen P, Vandrey RG, et al. Achieving Cannabis Cessation — Evaluating N-acetylcysteine Treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the national institute on drug abuse clinical trials network. Contemp Clin Trials. 2014;39:211–23. doi:10.1016/j.cct.2014.08.011.
   PubMed Web of Science ®Google Scholar
• Tomko RL, Baker NL, Hood CO, Gilmore AK, McClure EA, Squeglia LM, McRae-Clark AL, Sonne SC, Gray KM, et al. Depressive symptoms and cannabis use in a placebo-controlled trial of N-acetylcysteine for adult cannabis use disorder. Psychopharmacology (Berl). 2020;237:479–90. doi:10.1007/s00213-019-05384-z.
   PubMed Web of Science ®Google Scholar
• Hser YI, Mooney LJ, Huang D, Zhu Y, Tomko RL, McClure E, Chou C-P, Gray KM, et al. Reductions in cannabis use are associated with improvements in anxiety, depression, and sleep quality, but not quality of life. J Subst Abuse Treat. 2017;81:53–58.
   PubMed Web of Science ®Google Scholar
• Heishman SJ, Singleton EG, Liguori A. Marijuana craving questionnaire: development and initial validation of a self-report instrument. Addiction. 2001;96:1023–34. doi:10.1046/j.1360-0443.2001.967102312.x.
   PubMed Web of Science ®Google Scholar
• Heishman SJ, Evans RJ, Singleton EG, Levin KH, Copersino ML, Gorelick DA. Reliability and validity of a short form of the marijuana craving questionnaire. Drug Alcohol Depend. 2009;102:35–40. doi:10.1016/j.drugalcdep.2008.12.010.
   PubMed Web of Science ®Google Scholar
• Foster KT, Li N, McClure EA, Sonne SC, Gray KM. Gender differences in internalizing symptoms and suicide risk among men and women seeking treatment for cannabis use disorder from late adolescence to middle adulthood. J Subst Abuse Treat. 2016;66:16–22. doi:10.1016/j.jsat.2016.01.012.
   PubMed Web of Science ®Google Scholar
• Stephens RS, Roffman RA, Curtin L. Comparison of extended versus brief treatments for marijuana use. J Consult Clin Psychol. 2000;68:898–908. doi:10.1037/0022-006X.68.5.898.
   PubMed Web of Science ®Google Scholar
• Zigmond AS, Snaith RP.The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. doi:10.1111/j.1600-0447.1983.tb09716.x.
   PubMed Web of Science ®Google Scholar
• Catz SL, Jack LM, McClure JB, Javitz HS, Deprey M, Zbikowski SM, McAfee T, Richards J, Swan GE, et al. Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine Tob Res. 2011;13:361–68. doi:10.1093/ntr/ntr003.
   PubMed Web of Science ®Google Scholar
• Bates D, Machler M, Bolker BM, Walker SC. Fitting linear mixed-effects models using lme4. J Stat Soft. 2015;67:1–48. doi:10.18637/jss.v067.i01.
   Web of Science ®Google Scholar
• Nieuwenhuis R, Te Grotenhuis M, Pelzer BIM. Tools for detecting influential data in mixed effects models. R J. 2012;4:38–47. doi:10.32614/RJ-2012-011.
   Google Scholar
• Thomas JL, Guo H, Lynam IM, Powell JN, Okuyemi KS, Bronars CA, Ahluwalia JS, et al. The impact of perceived treatment assignment on smoking cessation outcomes among African-American smokers. J Gen Intern Med. 2008;23:1361–66. doi:10.1007/s11606-008-0656-3.
   PubMed Web of Science ®Google Scholar
• Hrobjartsson A, Forfang E, Haahr MT, Als-Nielsen B, Brorson S. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol. 2007;36:654–63. doi:10.1093/ije/dym020.
   PubMed Web of Science ®Google Scholar
• James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation–a VA cooperative study. Stat Med. 1996;15:1421–34. doi:10.1002/(SICI)1097-0258(19960715)15:13<1421:AID-SIM266>3.0.CO;2-H.
   PubMed Web of Science ®Google Scholar
• Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25:143–56. doi:10.1016/j.cct.2003.10.016.
   PubMedGoogle Scholar
• Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol. Clin Res Regul Aff. 2010;27:42–51. doi:10.3109/10601331003777444.
   Google Scholar
• Arandjelovic O. A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials. PLoS One. 2012;7:e48984. doi:10.1371/journal.pone.0048984.
   PubMedGoogle Scholar
• Arandjelovic O.Clinical trial adaptation by matching evidence in complementary patient sub-groups of auxiliary blinding questionnaire responses. PLoS One. 2015;10:e0131524. doi:10.1371/journal.pone.0131524.
   PubMed Web of Science ®Google Scholar
• Kirsch I. Response expectancy and the placebo effect. Int Rev Neurobiol. 2018;138:81–93.
   PubMed Web of Science ®Google Scholar
• Colagiuri B. Participant expectancies in double-blind randomized placebo-controlled trials: potential limitations to trial validity. Clin Trials. 2010;7:246–55. doi:10.1177/1740774510367916.
   PubMed Web of Science ®Google Scholar
• Connor JP, Stjepanovic D, Budney AJ, Le Foll B, and Hall WD. Clinical management of cannabis withdrawal. Addiction. 2022;117:2075-2095.
   Web of Science ®Google Scholar