PMID- 30154694
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1662-4548 (Print)
IS  - 1662-453X (Electronic)
IS  - 1662-453X (Linking)
VI  - 12
DP  - 2018
TI  - Self-Reported Effectiveness and Safety of Trokie((R)) Lozenges: A Standardized 
      Formulation for the Buccal Delivery of Cannabis Extracts.
PG  - 564
LID - 10.3389/fnins.2018.00564 [doi]
LID - 564
AB  - Therapeutic use of cannabinoids, the main active ingredients of Cannabissativa 
      L., is often hindered by their limited bioavailability and undesirable 
      psychoactivity. We conducted an observational study in December 2016 and another 
      one in February 2018 to investigate respectively: (i) the effectiveness of 
      Trokie((R)) lozenges, a standardized formulation containing cannabis extracts, to 
      deliver cannabinoids via buccal absorption and (ii) its long-term safety. 
      Participants were members of the Palliative Care Corporation health clinic, 
      registered California cannabis patients, and had a diagnosis of chronic 
      non-cancer pain. For the effectiveness study, 49 participants were asked to 
      self-report pain perception before and after 1-12 weeks of taking Trokie((R)) 
      lozenges, using an 11-point pain intensity numeric rating scale (PI-NRS). A mean 
      reduction in PI-NRS score of 4.9 +/- 2.0 points was observed. Onset of analgesia 
      typically varied between 5 and 40 min, which seems consistent with, at least 
      partial, buccal absorption. In the safety study, 35 participants were asked to 
      complete a questionnaire about adverse events (AEs) associated with Trokie((R)) 
      lozenges. AEs were reported by 16 subjects (46%), the most common being 
      dizziness/unsteadiness (N = 7), bad taste (N = 5), and throat irritation/dry 
      mouth (N = 4). None of the self-reported AEs resulted in a serious medical 
      situation and most of them had limited impact on daily functions. Despite the 
      AEs, 90% of participants reported being "satisfied" or "very satisfied" with the 
      product. These observations suggest that buccal administration of standardized 
      extracts via Trokie((R)) lozenges may represent an efficacious and safe approach to 
      cannabis administration.
FAU - Crowley, Kenton
AU  - Crowley K
AD  - Palliative Care Corporation, Huntington Beach, CA, United States.
FAU - de Vries, Sieta T
AU  - de Vries ST
AD  - Department of Clinical Pharmacy and Pharmacology, University of Groningen, 
      University Medical Center Groningen, Groningen, Netherlands.
FAU - Moreno-Sanz, Guillermo
AU  - Moreno-Sanz G
AD  - Abagune Research, Vitoria-Gasteiz, Spain.
AD  - Phytoplant Research S.L., Cordoba, Spain.
LA  - eng
PT  - Journal Article
DEP - 20180814
PL  - Switzerland
TA  - Front Neurosci
JT  - Frontiers in neuroscience
JID - 101478481
PMC - PMC6102350
OTO - NOTNLM
OT  - adverse events
OT  - buccal administration
OT  - cannabis
OT  - effectiveness
OT  - polyethylene glycol
OT  - safety
OT  - standardized
OT  - trokie(R) lozenges
EDAT- 2018/08/30 06:00
MHDA- 2018/08/30 06:01
PMCR- 2018/01/01
CRDT- 2018/08/30 06:00
PHST- 2018/03/11 00:00 [received]
PHST- 2018/07/26 00:00 [accepted]
PHST- 2018/08/30 06:00 [entrez]
PHST- 2018/08/30 06:00 [pubmed]
PHST- 2018/08/30 06:01 [medline]
PHST- 2018/01/01 00:00 [pmc-release]
AID - 10.3389/fnins.2018.00564 [doi]
PST - epublish
SO  - Front Neurosci. 2018 Aug 14;12:564. doi: 10.3389/fnins.2018.00564. eCollection 
      2018.