Clinical Studies and Case Reports

On this site you will find clinical studies with cannabis or single cannabinoids in different diseases and case reports on the use of cannabis by patients.
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TitleSafety of oral dronabinol during opioid withdrawal in humans
Author(s)Jicha CJ, Lofwall MR, Nuzzo PA, Babalonis S, Elayi SC, Walsh SL.
Journal, Volume, IssueDrug Alcohol Depend. 2015 Dec 1;157:179-83.
Major outcome(s)40 mg of THC caused increased heart rate and anxiety, which made dose-reduction necessary
IndicationDependency/withdrawalAbstract
MedicationDelta-9-THC

BACKGROUND: Opioid dependence remains a significant public health problem worldwide with only three FDA-approved treatments, all targeting the mu-opioid receptor. Dronabinol, a cannabinoid (CB) 1 receptor agonist, is currently under investigation as a novel opioid withdrawal treatment. This study reports on safety outcomes of dronabinol among adults in opioid withdrawal. METHODS: Twelve adults physically dependent on short-acting opioids participated in this 5-week within-subject, randomized, double blind, placebo-controlled inpatient study. Volunteers were maintained on oral oxycodone 30mgqid. Double-blind placebo substitutions occurred for 21h before each of 7 experimental sessions in order to produce opioid withdrawal. A single oral test dose was administered each session (placebo, oxycodone 30 and 60mg, dronabinol 5, 10, 20, and 30mg [decreased from 40mg]). Heart rate, blood pressure, respiratory outcomes and pupil diameter were assessed repeatedly. RESULTS: Dronabinol 40mg produced sustained sinus tachycardia accompanied by anxiety and panic necessitating dose reduction to 30mg. Sinus tachycardia and anxiety also occurred in one volunteer after dronabinol 20mg. Compared to placebo, dronabinol 20 and 30mg produced significant increases in heart rate beginning 1h after drug administration that lasted approximately 2h (p<0.05). Dronabinol 5 and 10mg produced placebo-like effects. Oxycodone produced prototypic mu-opioid agonist effects (e.g., miosis). CONCLUSION: Dronabinol 20mg and higher increased heart rate among healthy adults at rest who were in a state of opioid withdrawal, raising concern about its safety. These results have important implications for future dosing strategies and may limit the utility of dronabinol as a treatment for opioid withdrawal.

Route(s)Oral
Dose(s)up to 40mg
Duration (days)35
Participants12 opioid-dependent patients
DesignControlled study
Type of publicationMedical journal
Address of author(s)University of Kentucky College of Medicine (UK COM), Center on Drug and Alcohol Research, 845 Angliana Ave., Lexington, KY 40508, United States. Electronic address: crystal.jicha@uky.edu.
Full texthttp//:www.ncbi.nlm.nih.gov/pubmed/26483357

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