Hostname: page-component-cd9895bd7-q99xh Total loading time: 0 Render date: 2024-12-28T02:29:26.209Z Has data issue: false hasContentIssue false
  • English
  • Français

“Go Ask Alice”: The Case for Researching Schedule I Drugs

Published online by Cambridge University Press:  20 December 2018

KENNETH V. ISERSON
Get access Rights & Permissions [Opens in a new window]

Abstract:

The available treatments for disorders affecting large segments of the population are often costly, complex, and only marginally effective, and many have numerous side effects. These disorders include dementias, debilitating neurological disorders, the multiple types of drug addiction, and the spectrum of mental health disorders.

Preliminary studies have shown that a variety of psychedelic and similar U.S. Drug Enforcement Administration Schedule I drugs may offer better treatment options than those that currently exist and pose potentially the same or even less risk than do legal psychoactive (alcohol, caffeine, nicotine) and nonpsychoactive (aspirin, acetaminophen, ibuprofen) substances. The pharmaceutical industry and academia, however, have largely avoided this avenue of research.

Fairness to the affected populations demands that these drugs be adequately studied and, if they or their congeners are shown to be effective, made available with the proper caveats, instructions, and protections that other potentially abused medications (e.g., narcotics) receive. These substances may prove to relieve patients’ struggles with less effective treatments and decrease mortality from nontreatment of some conditions.

Keywords

bioethicspharmaceutical researchSchedule 1 drugsdrug and narcotic controluntreated/undertreated diseases
Type
Departments and Columns
Information
Cambridge Quarterly of Healthcare Ethics , Volume 28 , Issue 1 , January 2019 , pp. 168 - 177
Copyright
Copyright © Cambridge University Press 2018 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

References

Notes

1. World Health Organization. Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World Health Organization; 2017.Google Scholar

2. National Institute of Mental Health. Statistics; available at https://www.nimh.nih.gov/health/statistics/index.shtml (last accessed 4 May 2018).Google Scholar

3. National Institute on Alcohol Abuse and Alcoholism. Alcohol Facts and Statistics; available at https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-facts-and-statistics (last accessed 4 May 2018).Google Scholar

4. See note 3, National Institute on Alcohol Abuse and Alcoholism.

5. Parkinson’s Foundation. Statistics; available at http://parkinson.org/Understanding-Parkinsons/Causes-and-Statistics/Statistics (last accessed 4 May 2018).Google Scholar

6. National Institute for Drug Abuse. Opioid Overdose Crisis; available at https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis (last accessed 4 May 2018).Google Scholar

7. Centers for Disease Control and Prevention. Burden of Tobacco Use in the U.S.; available at https://www.cdc.gov/tobacco/campaign/tips/resources/data/cigarette-smoking-in-united-states.html (last accessed 4 May 2018).Google Scholar

8. Food and Drug Administration. Understanding Unapproved Use of Approved Drugs “Off Label”; available at https://www.fda.gov/ForPatients/Other/OffLabel/ucm20041767.htm (last accessed 12 April 2018).Google Scholar

9. Comprehensive Drug Abuse Prevention and Control Act. Pub.L. 91–513, 84 Stat.1236, enacted October 27, 1970.

10. U.S. Department of Justice, Drug Enforcement Agency. Controlled Substance Schedules; available at https://www.deadiversion.usdoj.gov/schedules/#define (last accessed 6 May 2018).Google Scholar

11. United Nations Convention on Psychotropic Substances; 1971; available at https://www.unodc.org/pdf/convention_1971_en.pdf (last accessed 6 May 2018).

12. Grinspoon, L, Bakalar, JB. Psychedelic Drugs Reconsidered. New York: Basic Books; 1979:221–3.Google Scholar

13. Rucker JJ, Iliff J, Nutt DJ. Psychiatry & the psychedelic drugs: Past, present & future. Neuropharmacology; forthcoming.

14. Carhart-Harris, RL, Goodwin, GM. The therapeutic potential of psychedelic drug: Past, present, and future. Neuropsychopharmacology 2017 Apr 26;42(11):1–9.CrossRefGoogle ScholarPubMed

15. Chwelos, N, Blewett, DB, Smith, CM, Hoffer, A. Use of d-lysergic acid diethylamide in the treatment of alcoholism. Quarterly Journal of Studies on Alcohol 1959;20:577–90.Google ScholarPubMed

16. See note 14, Carhart-Harris, Goodwin 2017:1–9.

17. Leuner, HA. Basic functions involved in the psychotherapeutic effect of psychotomimetics. Research in Psychotherapy. Washington DC: American Psychological Association; 1968:466–70.CrossRefGoogle Scholar

18. Sessa, B. Is there a case for MDMA-assisted psychotherapy in the UK? Journal of Psychopharmacology 2007 Mar;21(2):220–4.CrossRefGoogle Scholar

19. Gregoire, C. Everything You Wanted to Know About Microdosing (But Were Afraid to Ask); 2017 Jan 24; available at https://www.huffingtonpost.com/entry/psychedelic-microdosing-research_us_569525afe4b09dbb4bac9db8 (last accessed 6 May 2018).Google Scholar

20. See note 12, Grinspoon, Bakalar 1979:221–3.

21. See note 14, Carhart-Harris, Goodwin 2017:1–9.

22. Ibid.

23. Krebs, TS, Johansen, PO. Lysergic acid diethylamide (LSD) for alcoholism: Meta-analysis of randomized controlled trials. Journal of Psychopharmacology 2012;26(7):994–1002.CrossRefGoogle ScholarPubMed

24. Bogenschutz, MP, Forcehimes, AA, Pommy, JA, Wilcox, CE, Barbosa, PC, Strassman, RJ. Psilocybin-assisted treatment for alcohol dependence: A proof-of-concept study. Journal of Psychopharmacology 2015 Mar;29(3):289–99.CrossRefGoogle ScholarPubMed

25. Albaugh, BJ, Anderson, PO. Peyote in the treatment of alcoholism among American Indians. American Journal of Psychiatry 1974;131:1247–50.CrossRefGoogle ScholarPubMed

26. See note 23, Krebs, Johansen 2012:994–1002.

27. See note 13, Rucker JJ, Iliff J, Nutt DJ (forthcoming).

28. See note 24, Bogenschutz, Forcehimes, Pommy, Wilcox, Barbosa, Strassman, 2015:289–99.

29. Grob, CS, Danforth, AL, Chopra, GS, Hagerty, M, McKay, CR, Halberstadt, AL, et al. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Archives of General Psychiatry 2011;68(1):71–8.CrossRefGoogle ScholarPubMed

30. Griffiths, RR, Johnson, MW, Carducci, MA, Umbricht, A, Richards, WA, Richards, BD, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology 2016 Dec;30(12):1181–97.CrossRefGoogle ScholarPubMed

31. Ross, S, Bossis, A, Guss, J, Agin-Liebes, G, Malone, T, Cohen, B, et al. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Journal of Psychopharmacology 2016 Dec;30(12):1165–80.CrossRefGoogle ScholarPubMed

32. Johnson, MW, Griffiths, RR. Potential therapeutic effects of psilocybin. Neurotherapeutics 2017 Jul 1;14(3):734–40.CrossRefGoogle ScholarPubMed

33. Gasser, P, Holstein, D, Michel, Y, Doblin, R, Yazar-Klosinski, B, Passie, T, et al. Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. Journal of Nervous and Mental Disease 2014 Jul;202(7):513.CrossRefGoogle ScholarPubMed

34. Murphy, DG, Daly, E, Schmitz, N, Toal, F, Murphy, K, Curran, S, et al. Cortical serotonin 5-HT2A receptor binding and social communication in adults with Asperger’s syndrome: An in vivo SPECT study. American Journal of Psychiatry 2006;163:934–6.CrossRefGoogle Scholar

35. Sewell, RA, Halpern, JH, Pope, HG. Response of cluster headache to psilocybin and LSD. Neurology 2006;66:1920–2.CrossRefGoogle ScholarPubMed

36. Karst, M, Halpern, JH, Bernateck, M, Passie, T. The non-hallucinogen 2-bromo-lysergic acid diethylamide as preventative treatment for cluster headache: An open, non-randomized case series. Cephalalgia 2010;30:1140–4.CrossRefGoogle ScholarPubMed

37. See note 36, Karst, Halpern, Bernateck, Passie, 2010:1140–4.

38. Bird S. Mephedrone and cocaine: Clues from Army testing. Straight Statistics; 2011; available at http://straightstatistics.fullfact.org/article/mephedrone-and-cocaine-clues-army-testing (last accessed 5 May 2018).

39. Schenberg, EE, De Castro Comis, MA, Chaves, BR, Da Silveira, DX. Treating drug dependence with the aid of ibogaine: A retrospective study. Journal of Psychopharmacology 2014;28:993–1000.CrossRefGoogle ScholarPubMed

40. Carhart-Harris, RL, Bolstridge, M, Day, CM, Rucker, J, Watts, R, Erritzoe, DE, et al. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology 2018 Feb 1;235(2):399–408.CrossRefGoogle ScholarPubMed

41. Osório, FD, Sanches, RF, Macedo, LR, dos Santos, RG, Maia-de-Oliveira, JP, Wichert-Ana, L, et al. Antidepressant effects of a single dose of ayahuasca in patients with recurrent depression: A preliminary report. Revista Brasileira de Psiquiatria. 2015 Mar;37(1):13–20.CrossRefGoogle Scholar

42. Sanches, RF, de Lima Osório, F, Dos Santos, RG, Macedo, LR, Maia-de-Oliveira, JP, Wichert-Ana, L, et al. Antidepressant effects of a single dose of ayahuasca in patients with recurrent depression: A SPECT study. J Clin Psychopharmacol 2016 Feb 1;36(1):77–81.CrossRefGoogle ScholarPubMed

43. Hendricks, PS, Thorne, CB, Clark, CB, Coombs, DW, Johnson, MW. Classic psychedelic use is associated with reduced psychological distress and suicidality in the United States adult population. Journal of Psychopharmacology 2015 Mar;29(3):280–8.CrossRefGoogle Scholar

44. Carhart-Harris, RL, Bolstridge, M, Rucker, J, Day, CM, Erritzoe, D, Kaelen, M, et al. Psilocybin with psychological support for treatment-resistant depression: An open-label feasibility study. Lancet Psychiatry 2016 Jul 1;3(7):619–27.CrossRefGoogle Scholar

45. Moreno, FA, Wiegand, CB, Taitano, EK, Delgado, PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. Journal of Clinical Psychiatry 2006 Nov 11;67(11):1735–40.CrossRefGoogle ScholarPubMed

46. Brown, TK, Alper, K. Treatment of opioid use disorder with ibogaine: Detoxification and drug use outcomes. American Journal of Drug and Alcohol Abuse. 2018 Jan 2;44(1):24–36.CrossRefGoogle ScholarPubMed

47. Malcolm, BJ, Polanco, M, Barsuglia, JP. Changes in withdrawal and craving scores in participants undergoing opioid detoxification utilizing ibogaine. Journal of Psychoactive Drugs 2018 Apr 1:1–10.Google ScholarPubMed

48. Litjens RP, Brunt TM. How toxic is ibogaine? Clinical Toxicology 2016 Apr 20;54(4):297–302.

49. Huot, P, Johnston, TH, Lewis, KD, Koprich, JB, Reyes, MG, Fox, SH, et al. Characterization of 3,4-methylenedioxymethamphetamine (MDMA) enantiomers in vitro and in the MPTP-lesioned primate: R-MDMA reduces severity of dyskinesia, whereas S-MDMA extends duration of ON-time. Journal of Neuroscience 2011;31:7190–8.CrossRefGoogle ScholarPubMed

50. Busch, AK, Johnson, WC. L.S.D. 25 as an aid in psychotherapy: Preliminary report of a new drug. Diseases of the Nervous System 1950:11(8):241–3.Google ScholarPubMed

51. Hoch, PH, Cattell, JP, Pennes, HH. Effects of mescaline and lysergic acid (d-LSD-25). American Journal of Psychiatry 1952 Feb;108(8):579–84.CrossRefGoogle Scholar

52. Denber, HCB, Merlis, S. Studies on mescaline I: Action in schizophrenic patients. Psychiatric Quarterly 1955;29:421–9.CrossRefGoogle ScholarPubMed

53. Pennes, HH. Clinical reactions of schizophrenics to sodium amytal, pervitin hydrochloride, mescaline sulfate, and d-lysergic acid diethylamide (LSD25). Journal of Nervous and Mental Disease 1954;119(2):95–112.CrossRefGoogle Scholar

54. Merlis, S. The effects of mescaline sulfate in chronic schizophrenia. Journal of Nervous and Mental Disease 1957 Jul 1;125(3):432–3.CrossRefGoogle ScholarPubMed

55. Bedi, G, Luan Phan, K, Angstadt, M, de Wit, H. Effects of MDMA on sociability and neural response to social threat and social reward. Psychopharmacology (Berl.) 2009;207:73–83.CrossRefGoogle ScholarPubMed

56. Mithoefer, MC, Wagner, MT, Mithoefer, AT, Jerome, L, Martin, SF, Yazar-Klosinski, B, et al. Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: A prospective long-term follow-up study. Journal of Psychopharmacology 2013;27(1):28–39.CrossRefGoogle ScholarPubMed

57. Nichols, DE. Psychedelics. Pharmacology Review 2016 Apr 1;68(2):264–355.CrossRefGoogle ScholarPubMed

58. Johnson, MW, Garcia-Romeu, A, Griffiths, RR. Long-term follow-up of psilocybin-facilitated smoking cessation. American Journal of Drug and Alcohol Abuse 2017;43:55–60.CrossRefGoogle ScholarPubMed

59. See note 58, Johnson, Garcia-Romeu, Griffiths, 2017:55–60.

60. Nichols, DE, Johnson, MW, Nichols, CD. Psychedelics as medicines: An emerging new paradigm. Clinical Pharmacology & Therapeutics 2017 Feb 1;101(2):209–19.CrossRefGoogle Scholar

61. See note 57, Nichols, 2016:264–355.

62. See note 57, Nichols, 2016:264–355.

63. See note 57, Nichols, 2016:264–355.

64. Harman, WW, McKim, RH, Mogar, RE, Fadiman, J, Stolaroff, MJ. Psychedelic agents in creative problem-solving: A pilot study. Psychology Reports 1966 Aug;19(1):211–27.CrossRefGoogle ScholarPubMed

65. Krippner, S. Psychedelic drugs and creativity. Journal of Psychoactive Drugs 1985 Oct 1;17(4):235–46.CrossRefGoogle ScholarPubMed

66. Emanuel, EJ, Wendler, D, Grady, C. What makes clinical research ethical? JAMA 2000;283(20):2701–11.CrossRefGoogle ScholarPubMed

67. Sellers, EM, Leiderman, DB. Psychedelic drugs as therapeutics: No illusions about the challenges. Clinical Pharmacology and Therapeutics 2018 Apr 1;103(4):561–4.CrossRefGoogle ScholarPubMed

68. See note 65, Emanuel, Wendler, Grady, 2000:2701–11.

69. See note 14, Carhart-Harris, Goodwin 2017:1–9.