PMID- 26505163
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20210109
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Print)
IS  - 0306-5251 (Linking)
VI  - 81
IP  - 3
DP  - 2016 Mar
TI  - Single dose delta-9-tetrahydrocannabinol in chronic pancreatitis patients: 
      analgesic efficacy, pharmacokinetics and tolerability.
PG  - 525-37
LID - 10.1111/bcp.12811 [doi]
AB  - AIM: We aimed to assess the analgesic efficacy, pharmacokinetics, tolerability 
      and safety of a single dose of Delta9-THC in patients with chronic abdominal pain 
      resulting from chronic pancreatitis (CP). METHODS: This was a randomized, single 
      dose, double-blinded, placebo-controlled, two way crossover study in patients 
      suffering from abdominal pain as result of CP (n = 24), post hoc subdivided into 
      opioid and non-opioid users. Delta9-THC (8 mg) or active placebo (5 mg/10 mg 
      diazepam) was administered orally in a double dummy design. RESULTS: No treatment 
      effect was shown for delta VAS pain scores after Delta9-THC compared with diazepam. 
      Delta9-THC was well absorbed with a mean tmax of 123 min. No significant differences 
      were found between Delta9-THC vs. diazepam for alertness, mood, calmness or balance. 
      Feeling anxious and heart rate were significantly increased after Delta9-THC compared 
      with diazepam. The most frequently reported adverse events (AEs) after Delta9-THC 
      administration were somnolence, dry mouth, dizziness and euphoric mood. 
      CONCLUSIONS: A single dose of Delta9-THC was not efficacious in reducing chronic pain 
      resulting from CP, but was well tolerated with only mild or moderate AEs. The PK 
      results in CP patients showed delayed absorption and an increased variability 
      compared with healthy volunteers.
CI  - (c) 2015 The British Pharmacological Society.
FAU - de Vries, Marjan
AU  - de Vries M
AD  - Department of Surgery, Radboud University Medical Center, Nijmegen.
FAU - Van Rijckevorsel, Dagmar C M
AU  - Van Rijckevorsel DC
AD  - Department of Surgery, Radboud University Medical Center, Nijmegen.
FAU - Vissers, Kris C P
AU  - Vissers KC
AD  - Department of Anesthesiology, Pain and Palliative Medicine, Radboud University 
      Medical Center, Nijmegen, The Netherlands.
FAU - Wilder-Smith, Oliver H G
AU  - Wilder-Smith OH
AD  - Department of Anesthesiology, Pain and Palliative Medicine, Radboud University 
      Medical Center, Nijmegen, The Netherlands.
AD  - Centre for Sensory-Motor Interaction, Department of Health Sciences, Aalborg 
      University, Aalborg, Denmark.
FAU - Van Goor, Harry
AU  - Van Goor H
AD  - Department of Surgery, Radboud University Medical Center, Nijmegen.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160117
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
RN  - 0 (Analgesics, Non-Narcotic)
RN  - 7J8897W37S (Dronabinol)
RN  - EC 1.14.13.- (Cytochrome P-450 CYP2C9)
RN  - EC 1.14.14.1 (Cytochrome P-450 CYP2C19)
RN  - Q3JTX2Q7TU (Diazepam)
SB  - IM
MH  - Abdominal Pain/complications/*drug therapy
MH  - Adult
MH  - Aged
MH  - Analgesics, Non-Narcotic/adverse effects/blood/pharmacokinetics/therapeutic use
MH  - Chronic Pain/drug therapy
MH  - Cytochrome P-450 CYP2C19/genetics
MH  - Cytochrome P-450 CYP2C9/genetics
MH  - Diazepam/adverse effects/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Dronabinol/administration & dosage/adverse effects/*pharmacokinetics/*therapeutic 
      use
MH  - Female
MH  - Genotype
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement/drug effects
MH  - Pancreatitis, Chronic/complications/*drug therapy
PMC - PMC4767190
OTO - NOTNLM
OT  - THC
OT  - chronic pain
OT  - chronic pancreatitis
OT  - delta-9-tetrahydrocannabinol
OT  - dronabinol
EDAT- 2015/10/28 06:00
MHDA- 2016/12/15 06:00
PMCR- 2017/03/01
CRDT- 2015/10/28 06:00
PHST- 2015/06/30 00:00 [received]
PHST- 2015/10/16 00:00 [revised]
PHST- 2015/10/19 00:00 [accepted]
PHST- 2017/03/01 00:00 [pmc-release]
PHST- 2015/10/28 06:00 [entrez]
PHST- 2015/10/28 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - BCP12811 [pii]
AID - 10.1111/bcp.12811 [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2016 Mar;81(3):525-37. doi: 10.1111/bcp.12811. Epub 2016 Jan 
      17.