Brian J Sherman1, Margaret A Caruso2, Aimee L McRae-Clark3. 1. Department of Psychiatry and Behavioral Sciences, Medical Unviersity of South Carolina, 67 President Street, Charleston, SC 29425, USA. Electronic address: shermanb@musc.edu. 2. Department of Psychology, Auburn University, 226 Thach Hall, AL 36849, USA. 3. Department of Psychiatry and Behavioral Sciences, Medical Unviersity of South Carolina, 67 President Street, Charleston, SC 29425, USA; Ralph H. Johnson VAMC, 109 Bee Street, Charleston, SC 29401, USA.
Abstract
BACKGROUND: Sex differences in cannabis use disorder (CUD) and its treatment have been identified. Women report more severe withdrawal and have shown worse treatment outcomes. Ovarian hormones are implicated in these differences and research suggests that exogenous progesterone may be an effective pharmacotherapy. METHODS: The current randomized, placebo-controlled, feasibility trial tested a novel multimodal methodology for administering exogenous progesterone during acute cannabis withdrawal. Eight heavy cannabis using women received micronized progesterone (200 mg bid) (n = 3) or matching placebo (n = 5) during the early follicular phase of their menstrual cycle over a 5-day study period while abstaining from cannabis. Laboratory visits (days 1 and 5) included biological and self-report assessments, while home-based procedures (days 2-4) included ambulatory assessments, video data capture and tele-drug testing, and biological assessments. Primary outcomes were medication adherence and salivary hormone levels, and the exploratory outcome was cannabis withdrawal severity. RESULTS:Medication adherence rates were high as assessed via self-report (100.0%) and video data capture (98.0%). Salivary progesterone levels differed between groups over time (p < 0.027) and the progesterone group achieved levels within the normal range during the luteal phase in healthy adults. All tele-drug tests were negative confirming cannabis abstinence and there was an indication (p = 0.07) of reduced cannabis craving among participants receiving progesterone. CONCLUSION: More effective and sex-based treatments for cannabis use disorder are needed. The current study provides a novel multimodal methodology with low participant burden for investigating new medications for cannabis withdrawal. Clinical trials of progesterone for cannabis withdrawal may be warranted.
RCT Entities:
BACKGROUND: Sex differences in cannabis use disorder (CUD) and its treatment have been identified. Women report more severe withdrawal and have shown worse treatment outcomes. Ovarian hormones are implicated in these differences and research suggests that exogenous progesterone may be an effective pharmacotherapy. METHODS: The current randomized, placebo-controlled, feasibility trial tested a novel multimodal methodology for administering exogenous progesterone during acute cannabis withdrawal. Eight heavy cannabis using women received micronized progesterone (200 mg bid) (n = 3) or matching placebo (n = 5) during the early follicular phase of their menstrual cycle over a 5-day study period while abstaining from cannabis. Laboratory visits (days 1 and 5) included biological and self-report assessments, while home-based procedures (days 2-4) included ambulatory assessments, video data capture and tele-drug testing, and biological assessments. Primary outcomes were medication adherence and salivary hormone levels, and the exploratory outcome was cannabis withdrawal severity. RESULTS: Medication adherence rates were high as assessed via self-report (100.0%) and video data capture (98.0%). Salivary progesterone levels differed between groups over time (p < 0.027) and the progesterone group achieved levels within the normal range during the luteal phase in healthy adults. All tele-drug tests were negative confirming cannabis abstinence and there was an indication (p = 0.07) of reduced cannabis craving among participants receiving progesterone. CONCLUSION: More effective and sex-based treatments for cannabis use disorder are needed. The current study provides a novel multimodal methodology with low participant burden for investigating new medications for cannabis withdrawal. Clinical trials of progesterone for cannabis withdrawal may be warranted.
Authors: Brian J Sherman; Aimee L McRae-Clark; Nathaniel L Baker; Susan C Sonne; Therese K Killeen; Kasie Cloud; Kevin M Gray Journal: Am J Addict Date: 2017-02-02
Authors: Thomas M Shiovitz; Earle E Bain; David J McCann; Phil Skolnick; Thomas Laughren; Adam Hanina; Daniel Burch Journal: J Clin Pharmacol Date: 2016-01-22 Impact factor: 3.126
Authors: Rachel L Tomko; Kevin M Gray; Marilyn A Huestis; Lindsay M Squeglia; Nathaniel L Baker; Erin A McClure Journal: Curr Addict Rep Date: 2019-11-19
Authors: Jessica L Sharp; Sarah B Ethridge; Shannon L Ballard; Kenzie M Potter; Karl T Schmidt; Mark A Smith Journal: Drug Alcohol Depend Date: 2021-06-18 Impact factor: 4.852
Authors: Jennifer Dahne; Rachel L Tomko; Erin A McClure; Jihad S Obeid; Matthew J Carpenter Journal: Nicotine Tob Res Date: 2020-12-12 Impact factor: 4.244