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Research Article

Safety and tolerability of progesterone treatment for women with cocaine use disorder: a pilot treatment trial

ORCID Icon, ORCID Icon, , ORCID Icon & ORCID Icon
Pages 586-595 | Received 15 Mar 2022, Accepted 13 Aug 2022, Published online: 12 Sep 2022

References

  • Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: results from the 2019 National Survey on Drug Use and Health. Rockville (MD): Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration; 2020 Sep [accessed 2022 Feb 16]. https://www.samhsa.gov/data/sites/default/files/reports/rpt29393/2019NSDUHFFRPDFWHTML/2019NSDUHFFR090120.htm.
  • Kennedy AP, Epstein DH, Phillips KA, Preston KL. Sex differences in cocaine/heroin users: drug-use triggers and craving in daily life. Drug Alcohol Depend. 2013;132:29–37. doi:10.1016/j.drugalcdep.2012.12.025. Cited in: PMID: 23357742.
  • Greenfield SF, Back SE, Lawson K, Brady KT. Substance abuse in women. Psychiatr Clin North Am. 2010;33:339–55. doi:10.1016/j.psc.2010.01.004. Cited in: PMID: 20385341.
  • O’Brien MS, Anthony JC. Risk of becoming cocaine dependent: epidemiological estimates for the United States, 2000-2001. Neuropsychopharmacol. 2005;30:1006–18. doi:10.1038/sj.npp.1300681. Cited in: PMID: 15785780.
  • Chan B, Kondo K, Freeman M, Ayers C, Montgomery J, Kansagara D. Pharmacotherapy for cocaine use disorder-a systematic review and meta-analysis. J Gen Intern Med. 2019;34:2858–73. doi:10.1007/s11606-019-05074-8. Cited in: PMID: 31183685.
  • Sofuoglu M, Dudish-Poulsen S, Nelson D, Pentel PR, Hatsukami DK. Sex and menstrual cycle differences in the subjective effects from smoked cocaine in humans. Exp Clin Psychopharmacol. 1999;7:274–83. doi:10.1037//1064-1297.7.3.274. Cited in: PMID: 10472516.
  • White TL, Justice AJ, de Wit H. Differential subjective effects of d-amphetamine by gender, hormone levels and menstrual cycle phase. Pharmacol Biochem Behav. 2002;73:729–41. doi:10.1016/s0091-3057(02)00818-3. Cited in: PMID: 12213517.
  • Evans SM, Haney M, Foltin RW. The effects of smoked cocaine during the follicular and luteal phases of the menstrual cycle in women. Psychopharmacology (Berl). 2002;159:397–406. doi:10.1007/s00213-001-0944-7. Cited in: PMID: 11823892.
  • Evans SM, Foltin RW. Exogenous progesterone attenuates the subjective effects of smoked cocaine in women, but not in men. Neuropsychopharmacology. 2006;31:659–74. doi:10.1038/sj.npp.1300887. Cited in: PMID: 16160708.
  • Sofuoglu M, Babb DA, Hatsukami DK. Effects of progesterone treatment on smoked cocaine response in women. Pharmacol Biochem Behav. 2002;72:431–35. doi:10.1016/s0091-3057(02)00716-5. Cited in: PMID: 11900816.
  • Sofuoglu M, Mitchell E, Kosten TR. Effects of progesterone treatment on cocaine responses in male and female cocaine users. Pharmacol Biochem Behav. 2004;78:699–705. doi:10.1016/j.pbb.2004.05.004. Cited in: PMID: 15301924.
  • Reed SC, Evans SM, Bedi G, Rubin E, Foltin RW. The effects of oral micronized progesterone on smoked cocaine self-administration in women. Horm Behav. 2011;59:227–35. doi:10.1016/j.yhbeh.2010.12.009. Cited in: PMID: 21192940.
  • Pang RD, Liautaud MM, Kirkpatrick MG, Huh J, Monterosso J, Leventhal AM. Ovarian hormones and transdermal nicotine administration independently and synergistically suppress tobacco withdrawal symptoms and smoking reinstatement in the human laboratory. Neuropsychopharmacology. 2018;43:828–37. doi:10.1038/npp.2017.216. Cited in: PMID: 28905874.
  • Sofuoglu M, Babb D, Hatsukami D. Progesterone treatment during the early follicular phase of the menstrual cycle: effects on smoking behavior in women. Pharmacol Biochem Behav. 2001;69:299–304. doi:10.1016/S0091-3057(01)00527-5. Cited in: PMID: 11420098.
  • Sofuoglu M, Mouratidis M, Mooney M. Progesterone improves cognitive performance and attenuates smoking urges in abstinent smokers. Psychoneuroendocrinology. 2011;36:123–32. doi:10.1016/j.psyneuen.2010.07.005. Cited in: PMID: 20675057.
  • Saladin ME, McClure EA, Baker NL, Carpenter MJ, Ramakrishnan V, Hartwell KJ, Gray KM. Increasing progesterone levels are associated with smoking abstinence among free-cycling women smokers who receive brief pharmacotherapy. Nicotine Tob Res. 2015;17:398–406. doi:10.1093/ntr/ntu262. Cited in: PMID: 25762749.
  • Schiller CE, Saladin ME, Gray KM, Hartwell KJ, Carpenter MJ. Association between ovarian hormones and smoking behavior in women. Exp Clin Psychopharmacol. 2012;20:251–57. doi:10.1037/a0027759. Cited in: PMID: 22545725.
  • Allen SS, Bade T, Center B, Finstad D, Hatsukami D. Menstrual phase effects on smoking relapse. Addiction. 2008;103:809–21. doi:10.1111/j.1360-0443.2008.02146.x. Cited in: PMID: 18412759.
  • Tosun NL, Fieberg AM, Eberly LE, Harrison KA, Tipp AR, Allen AM, Allen SS. Exogenous progesterone for smoking cessation in men and women: a pilot double-blind, placebo-controlled randomized clinical trial. Addiction. 2019;114:1800–13. doi:10.1111/add.14645. Cited in: PMID: 31059177.
  • Sofuoglu M, Poling J, Gonsai K, Oliveto A, Kosten T. Progesterone effects on cocaine use in male cocaine users maintained on methadone: a randomized, double-blind, pilot study. Exp Clin Psychopharmacol. 2007;15:453–60. doi:10.1037/1064-1297.15.5.453. Cited in: PMID: 17924779.
  • Yonkers KA, Forray A, Nich C, Carroll KM, Hine C, Merry B, Shaw H, Shaw J, Sofuoglu M. Progesterone reduces cocaine use in postpartum women with cocaine use disorder: a randomized, double-blind study. Lancet Psychiatry. 2014;1:360–67. doi:10.1016/S2215-0366(14)70333-5. Cited in: PMID: 25328863.
  • Specker S. ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (U.S.). Progesterone for the treatment of cocaine dependence. 2005 Sept 22 [accessed 2022 Feb 22]. https://clinicaltrials.gov/ct2/show/study/NCT00218257.
  • First MB, Spitzer RL, Gibbon M, Williams JBW Structured Clinical Interview for DSM-IV Axis I Disorders Patient Edition (SCID-I/P, version 2.0). Biometrics Research Department, New York State Psychiatric Institute. 1994.
  • Sobell LC, Sobell MB, Buchan G, Cleland PA, Fedoroff I, Leo GI The reliability of the Timeline Follow Back method applied to drug, cigarette, and cannabis use. Paper presented at: the 30th Annual Meeting of the Association for Advancement of Behavior Therapy; 1996 Nov 21-24; New York, NY.
  • Levin FR, Mariani JJ, Specker S, Mooney M, Mahony A, Brooks DJ, Babb D, Bai Y, Eberly LE, Nunes EV, et al. Extended-Release mixed amphetamine salts vs placebo for comorbid adult attention-deficit/hyperactivity disorder and cocaine use disorder: a randomized clinical trial. JAMA Psychiatry. 2015;72:593–602. doi:10.1001/jamapsychiatry.2015.41. Cited in: PMID: 25887096.
  • Levin FR, Mariani JJ, Pavlicova M, Choi CJ, Mahony AL, Brooks DJ, Bisaga A, Dakwar E, Carpenter KM, Naqvi N, et al. Extended release mixed amphetamine salts and topiramate for cocaine dependence: a randomized clinical replication trial with frequent users. Drug Alcohol Depend. 2020;206:107700. doi:10.1016/j.drugalcdep.2019.107700. Cited in: PMID: 31753736.
  • Levine J, Schooler NR. SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacol Bull. 1986;22:343–81. PMID: 3774930.
  • Evans SM, Levin FR, Brooks DJ, Garawi F. A pilot double-blind treatment trial of memantine for alcohol dependence. Alcohol Clin Exp Res. 2007;31:775–82. doi:10.1111/j.1530-0277.2007.00360.x. Cited in: PMID: 17378918.
  • Preston KL, Silverman K, Schuster CR, Cone EJ. Assessment of cocaine use with quantitative urinalysis and estimation of new uses. Addiction. 1997;92:717–27. doi:10.1111/j.1360-0443.1997.tb02938.x.
  • Herron AJ, Mariani JJ, Pavlicova M, Parrinello CM, Bold KW, Levin FR, Nunes EV, Sullivan MA, Raby WN, Bisaga A. Assessment of riboflavin as a tracer substance: comparison of a qualitative to a quantitative method of riboflavin measurement. Drug Alcohol Depend. 2013;128:77–82. doi:10.1016/j.drugalcdep.2012.08.007. Cited in: PMID: 22921475.
  • Foltin RW, Haney M, Rubin E, Reed SC, Vadhan N, Balter R, Evans SM. Development of translational preclinical models in substance abuse: effects of cocaine administration on cocaine choice in humans and non-human primates. Pharmacol Biochem Behav. 2015;134:12–21. doi:10.1016/j.pbb.2015.03.023. Cited in: PMID: 25933796.
  • Haney M, Spealman R. Controversies in translational research: drug self-administration. Psychopharmacology (Berl). 2008;199:403–19. doi:10.1007/s00213-008-1079-x. Cited in: PMID: PMID: 18283437.
  • Shorter D, Kosten TR. Vaccines in the treatment of substance abuse. Focus (Am Psychiatr Publ). 2011;9:25–30. doi:10.1176/foc.9.1.foc25. Cited in: PMID: 23472050.
  • Bisaga A, Aharonovich E, Garawi F, Levin FR, Rubin E, Raby WN, Vosburg SK, Nunes EV. Utility of lead-in period in cocaine dependence pharmacotherapy trials. Drug Alcohol Depend. 2005;77:7–11. doi:10.1016/j.drugalcdep.2004.06.007. Cited in: PMID: 15607836.
  • Allen SS, Allen AM, Lunos S, Tosun N. Progesterone and postpartum smoking relapse: a pilot double-blind placebo-controlled randomized trial. Nicotine Tob Res. 2016;18:2145–53. doi:10.1093/ntr/ntw156. Cited in: PMID: 27613934.
  • Mongeau-Pérusse V, Brissette S, Bruneau J, Conrod P, Dubreucq S, Gazil G, Stip E, Jutras-Aswad D. Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. Addiction. 2021;116:2431–42. doi:10.1111/add.15417. Cited in: PMID: 33464660.
  • Hassan HE, Kelly D, Honick M, Shukla S, Ibrahim A, Gorelick DA, Glassman M, McMahon RP, Wehring HJ, Kearns AM, et al. Pharmacokinetics and safety assessment of i-tetrahydropalmatine in cocaine users: a randomized, double-blind, placebo-controlled study. J Clin Pharmacol. 2017;57:151–60. doi:10.1002/jcph.789. Cited in: PMID: 27363313.
  • Morgan PT, Angarita GA, Canavan S, Pittman B, Oberleitner L, Malison RT, Mohsenin V, Hodges S, Easton C, McKee S, et al. Modafinil and sleep architecture in an inpatient-outpatient treatment study of cocaine dependence. Drug Alcohol Depend. 2016;160:49–56. doi:10.1016/j.drugalcdep.2015.12.004. Cited in: PMID: 26777774.
  • Peltier MR, Sofuoglu M Role of exogenous progesterone in the treatment of men and women with substance use disorders: a narrative review. Cns Drugs. 2018;32:421–35. doi: 10.1007/s40263-018-0525-5. Cited in: PMID: 29761343.

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