Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: A study protocol

BMC Psychiatry

Volumn 18, Issue 1, 2018, Pages

  Bhardwaj, Anjali K ^a,b   Allsop, David J ^a   Copeland, Jan ^c   McGregor, Iain S ^a   Dunlop, Adrian ^d   Shanahan, Marian ^c   Bruno, Raimondo ^c,e   Phung, Nghi ^f   Montebello, Mark ^b   Sadler, Craig ^d   Gugusheff, Jessica ^a,b   Jackson, Melissa ^d   Luksza, Jennifer ^f   Lintzeris, Nicholas ^a,b   Hall, Michelle ^d   Hazelwood, Susan ^d   Winmill, Anthony ^d   Chan, Therese ^b   Dojcinovic, Raelene ^b   Jago, Betty ^b   McKendrick, Lynsey ^b   Rivas, Consuelo ^b   Schwanz, Ricardo ^b   Yang, Abigail ^b   Zavareh, Zachary ^b   Barbaro, Angelo ^g   Black, Kerin ^g   Ho, Tim ^g   Jefferies, Meryem ^g   Jule, Jonathon Coreas ^g   Nagubandi, Shyam ^g   Shahidi, Mahsa ^g   Lisa Snell, Catherine Silsbury ^g   Wijanto, Matthew ^g   more..

^a UNIVERSITY OF SYDNEY   (Australia)

^b SOUTH EASTERN SYDNEY LOCAL HEALTH DISTRICT   (Australia)

^c UNIVERSITY OF NEW SOUTH WALES   (Australia)

^d Drug Alcohol Clinical Services   (Australia)

^e UNIVERSITY OF TASMANIA   (Australia)

^f CUMBERLAND HOSPITAL   (Australia)

^g WESTERN SYDNEY LOCAL HEALTH DISTRICT   (Australia)

Author keywords

Agonist replacement; Cannabis; Cannabis withdrawal; Marijuana; Nabiximols; Study protocol

Indexed keywords

NABIXIMOLS; PLACEBO; CANNABIDIOL; CANNABINOID; DRONABINOL;

ADULT; ARTICLE; AUSTRALIA; CANNABIS ADDICTION; COGNITIVE BEHAVIORAL THERAPY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FOLLOW UP; GENERAL CONDITION IMPROVEMENT; HUMAN; MAJOR CLINICAL STUDY; MENTAL PERFORMANCE; MULTICENTER STUDY; OUTPATIENT DEPARTMENT; PARALLEL DESIGN; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SUBSTITUTION THERAPY; TOTAL QUALITY MANAGEMENT; TREATMENT DURATION; TREATMENT OUTCOME; COGNITION; CRAVING; DRUG COMBINATION; DRUG EFFECT; FEMALE; MALE; MULTIMODALITY CANCER THERAPY; NEW SOUTH WALES; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); WITHDRAWAL SYNDROME;

ADULT; AUSTRALIA; CANNABIDIOL; CANNABINOIDS; COGNITION; COGNITIVE BEHAVIORAL THERAPY; COMBINED MODALITY THERAPY; CRAVING; DOUBLE-BLIND METHOD; DRONABINOL; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MARIJUANA ABUSE; NEW SOUTH WALES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SUBSTANCE WITHDRAWAL SYNDROME; TREATMENT OUTCOME;

EID: 85047055456     PISSN: None     EISSN: 1471244X     Source Type: Journal    
DOI: 10.1186/s12888-018-1682-2     Document Type: Article

References (75)

1. UNODC. World Drug Report 2013. 2013: United Nations Publication, Sales No. E.13.XI.6.
2. UNODC. World drug report 2015. Vienna: United Nations Office on Drugs and Crime; 2015.
3. AIHW. Alcohol and other drug treatment services in Australia 2011-12. Canberra: AIHW; 2013.
4. Hasin DS, et al. Prevalence of marijuana use disorders in the United States between 2001-2002 and 2012-2013. JAMA psychiatry. 2015;72(12):1235-42.
5. Quality, C.f.B.H.S.a., 2015 National Survey on Drug Use and Health: Detailed Tables., in Substance Abuse and Mental Health Services Administration. 2016: Rockville, Maryland.
6. AIHW. In: D. Statistics, editor. 2016 National Drug Strategy Household Survey: preliminary findings. Canberra: AIHW; 2017.
7. Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet. 2009;374(9698):1383-91.
8. WHO. The health and social effects of nonmedical cannabis use. Geneva: Department of Mental Health and Substance Abuse (MSD); 2016. p. 95.
9. Roffman R, Stephens R. In: Edwards PG, editor. Cannabis dependence: its nature, consequences and treatment. International research monographs in the addictions. Cambridge: Cambridge University Press; 2006.
10. Collins D, Lapsley H. The costs of tobacco, alcohol and illicit drug abuse to Australian society in 2004-05. Canberra: D.o.H.a. Ageing; 2008.
11. AIHW. Alcohol and other drug treatment services in Australia 2014-2015. In: Drug and treatment series no.27. Canberra: AIHW; 2016.
12. Gates, P.J., et al., Psychosocial interventions for cannabis use disorder. Cochrane Database Syst Rev, 2016(5).
13. Allsop DJ, et al. Nabiximols as an agonist replacement therapy during Cannabis withdrawal: a randomized clinical trial. JAMA Psychiatry. 2014;71(3):281-91.
14. Johnston J, et al. A double blind, randomised, placebo controlled trial of lithium carbonate for the management of cannabis withdrawal. In: Drug and alcohol review. Hoboken: Wiley; 2013.
15. Danovitch I, Gorelick DA. State of the art treatments for cannabis dependence. Psychiatr Clin N Am. 2012;35(2):309-26.
16. Vandrey R, Haney M. Pharmacotherapy for cannabis dependence: how close are we? CNS Drugs. 2009;23(7):543-53.
17. Copeland J, Clement N, Swift W. Cannabis use, harms and the management of cannabis use disorder. Neuropsychiatry. 2014;4(1):55-63.
18. Marshall K, et al. Pharmacotherapies for cannabis dependence. Cochrane Database Syst Rev. 2014;12:Cd008940.
19. Carpenter KM, et al. A preliminary trial: double-blind comparison of nefazodone, bupropion-SR, and placebo in the treatment of cannabis dependence. Am J Addict. 2009;18(1):53-64.
20. Haney M, et al. Marijuana withdrawal in humans: effects of oral THC or divalproex. Neuropsychopharmacology. 2004;29(1):158-70.
21. Haney M, et al. Effects of THC and lofexidine in a human laboratory model of marijuana withdrawal and relapse. Psychopharmacology. 2008;197(1):157-68.
22. Gray KM, et al. A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents. Am J Psychiatr. 2012;169(8):805-12.
23. Darke S, Farrell M. Would legalizing illicit opioids reduce overdose fatalities? Implications from a natural experiment. Addiction. 2014;109(8):5.
24. Budney AJ, et al. Adults seeking treatment for marijuana dependence: a comparison with cocaine-dependent treatment seekers. Exp Clin Psychopharmacol. 1998;6(4):419-26.
25. Karst M, Wippermann S, Ahrens J. Role of cannabinoids in the treatment of pain and (painful) spasticity. Drugs. 2010;70(18):2409-38.
26. Karschner EL, et al. Plasma cannabinoid pharmacokinetics following controlled oral delta9-tetrahydrocannabinol and oromucosal cannabis extract administration. Clin Chem. 2011;57(1):66-75.
27. Huestis MA, et al. Characterization of the absorption phase of marijuana smoking. Clin Pharmacol Ther. 1992;52(1):31-41.
28. Levin FR, et al. Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2011;116(1-3):142-50.
29. Trigo JM, et al. Effects of fixed or self-titrated dosages of Sativex on cannabis withdrawal and cravings. Drug Alcohol Depend. 2016;161:298-306.
30. Trigo JM, et al. Sativex associated with behavioral-relapse prevention strategy as treatment for Cannabis dependence: a case series. J Addict Med. 2016;10(4):274-9.
31. Schulz KF, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
32. Chan A-W, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7.
33. Martin G, et al. The severity of dependence scale (SDS) in an adolescent population of cannabis users: reliability, validity and diagnostic cut-off. Drug Alcohol Depend. 2006;83(1):90-3.
34. Sobell, L.C. and M.B. Sobell, Timeline follow-back, in Measuring alcohol consumption. 1992, Springer. p. 41-72.
35. Allsop, D.J., M. Norberg, and J. Copeland, Development of a cannabis withdrawal scale. Centrelines, 2010.
36. Ryan A, et al. Validation and implementation of the Australian treatment outcomes profile in specialist drug and alcohol settings. Drug Alcohol Rev. 2014;33(1):33-42.
37. Overall JE, Gorman DR. The brief psychiatric rating scale. Psychol Rep. 1962;10:22.
38. D'Souza DC, et al. The psychotomimetic effects of intravenous delta-9-tetrahydrocannabinol in healthy individuals: implications for psychosis. Neuropsychopharmacology. 2004;29(8):1558-72.
39. Copeland J. Marijuana brief intervention: an SBIRT approach. Center City: Hazelden Publishing; 2017.
40. Norberg MM, Mackenzie J, Copeland J. Quantifying cannabis use with the timeline Followback approach: a psychometric evaluation. Drug Alcohol Depend. 2012;121(3):247-52.
41. Mattick, R.P., et al. Minimizing the unintended consequences of opioid treatment: development of a drug behavior scale for use in Australia. In: College on Problems of Drug Dependence. 2012. Palm Spings, USA.
42. Crichton N. Visual analogue scale (VAS). J Clin Nurs. 2001;10(5):706.
43. Connock, M., et al., Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. 2007.
44. Doran CM, et al. Buprenorphine versus methadone maintenance: a cost-effectiveness analysis. Drug Alcohol Depend. 2003;71(3):295-302.
45. Harris AH, Gospodarevskaya E, Ritter AJ. A randomised trial of the cost effectiveness of buprenorphine as an alternative to methadone maintenance treatment for heroin dependence in a primary care setting. PharmacoEconomics. 2005;23(1):77-91.
46. Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004;42(9):851-9.
47. Drummond C, et al. Effectiveness and cost-effectiveness of a stepped care intervention for alcohol use disorders in primary care: pilot study. Br J Psychiatry. 2009;195(5):448-56.
48. Rolling K. Counting the costs of crime in Australia: a 2005 update. Canberra: A.I.o. Criminology; 2008.
49. Organisation, W.H., World Health Organization health and performance questionnaire (HPQ): clinical trials baseline version. 2002.
50. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473-83.
51. Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales. Sydney: Psychology Foundation; 1995.
52. Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002;64(2):258-66.
53. Cleeland C, Ryan K. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singap. 1994;23(2):129-38.
54. Soldatos CR, Dikeos DG, Paparrigopoulos TJ. Athens insomnia scale: validation of an instrument based on ICD-10 criteria. J Psychosom Res. 2000;48(6):555-60.
55. Darke S, et al. Development and validation of a multi-dimensional instrument for assessing outcome of treatment among opiate users: the opiate treatment index. Br J Addict. 1992;87(5):733-42.
56. Eriksen B, Eriksen C. Effects of noise letters upon the identification of a target letter in a nonsearch task. Percept Psychophys. 1974;16(1):143-9.
57. Logan GD, Schachar RJ, Tannock R. Impulsivity and inhibitory control. Psychol Sci. 1997;8:60-4.
58. Jonides J, et al. Verbal working memory load affects regional brain activation as measured by PET. J Cogn Neurosci. 1997;9(4):462-75.
59. Mattila M, Mattila-Evenden M. Effects of alcohol and hypnosedative drugs on digit-symbol substitution: comparison of two different computerized tests. J Psychopharmacol. 1997;11(4):313-7.
60. Wesnes K, Warburton DM. Effects of smoking on rapid information processing performance. Neuropsychobiology. 1983;9(4):223-9.
61. Wechsler, D. Wechsler Test of Adult Reading: WTAR. 2001: Psychological Corporation.
62. Rey, A., L'examen psychologique dans les cas d'encéphalopathie traumatique.(Les problems.). 1941. Archives de psychologie.
63. Cameron E, Sinclair W, Tiplady B. Validity and sensitivity of a pen computer battery of performance tests. J Psychopharmacol. 2001;15(2):105-10.
64. Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manip Physiol Ther. 2004;27(1):26-35.
65. Huestis MA, Mitchell JM, Cone EJ. Urinary excretion profiles of 11-Nor-9-Carboxy-Δ9-tetrahydrocannabinol in humans after single smoked doses of marijuana. J Anal Toxicol. 1996;20(6):441-52.
66. Heishman SJ, Singleton EG, Liguori A. Marijuana craving questionnaire: development and initial validation of a self-report instrument. Addiction. 2001;96(7):1023-34.
67. Copeland J, et al. The Cannabis problems Questionair: factor structure, reliability, and validity. Drug Alcohol Depend. 2005;80:313-9.
68. Stephens RS, Wertz JS, Roffman RA. Self-efficacy and marijuana cessation: a construct validity analysis. J Consult Clin Psychol. 1995;63(6):1022-31.
69. Heatherton TF, et al. The Fagerstrom test for nicotine dependence: a revision of the Fagerstrom tolerance questionnaire. Br J Addict. 1991;86(9):1119-27.
70. Saunders JB, et al. Development of the alcohol use disorders screening test (AUDIT). WHO collaborative project on early detection of persons with harmful alcohol consumption. Addiction. 1993;88:791-804.
71. Larance B, et al. Development of a brief tool for monitoring aberrant behaviours among patients receiving long-term opioid therapy: the opioid-related Behaviours in treatment (ORBIT) scale. Drug Alcohol Depend. 2016;159:42-52.
72. Cameron RP, Gusman D. The primary care PTSD screen (PC-PTSD): development and operating characteristics. Primary Care Psychiatry. 2003;9(1):9-14.
73. Leon AC, et al. Assessing psychiatric impairment in primary care with the Sheehan disability scale. Int J Psychiatry Med. 1997;27(2):93-105.
74. Kessler RC, et al. The world health organization health and work performance questionnaire (HPQ). J Occup Environ Med. 2003;45(2):156-74.
75. Shanahan MD, et al. A cost-effectiveness analysis of heroin detoxification methods in the Australian National Evaluation of pharmacotherapies for opioid dependence (NEPOD). Addict Behav. 2006;31(3):371-87.