PMID- 24040851
OWN - NLM
STAT- MEDLINE
DCOM- 20140116
LR  - 20181211
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 51
IP  - 11
DP  - 2013 Nov
TI  - One year long-term study on abuse liability of nalfurafine in hemodialysis 
      patients.
PG  - 823-31
LID - 10.5414/CP201852 [doi]
AB  - Nalfurafine (nalfurafine hydrochloride, TRK-820, Remitch(R)) was launched as an 
      anti-pruritic for uremic pruritus in hemodialysis patients in Japan in 2009. 
      Since the drug is an opioid that mainly binds to kappa-receptors and possesses 
      kappa-agonistic pharmacological properties and also binds partially, but very weakly, 
      to mu-receptors, the abuse liability of the drug was assessed by using 
      questionnaires in patients enrolled in a clinical trial evaluating the efficacy 
      and safety of the drug. The clinical trial was conducted for up to 52 weeks in 
      patients subjected to regular hemodialysis. End-stage renal disease (ESRD) 
      patients with uremic pruritus (n = 146) were administered nalfurafine 5 mug 
      intravenously after each hemodialysis session. 81 ESRD patients without uremic 
      pruritus served as non-treatment controls. All pruritus patients answered the 3 
      questionnaires of "the Addiction Research Centre Inventory (ARCI)", "modified 
      Short Opiate Withdrawal Scale (SOWS)", which provides a range of signs and 
      symptoms of opiate withdrawal, and Severity of Dependence Scale (SDS), which 
      measures the dependence potential of the drug. The control patients were tested 
      with the ARCI and modified SOWS questionnaires. There were no significant 
      differences between the nalfurafine group and control group in the ARCI and 
      modified SOWS scales. Thus, no evidence of abuse liability was indicated in the 
      results. Also, no significant differences in the blood pressure, respiratory 
      rate, body temperature and pupil diameter were shown between the two groups.
FAU - Ueno, Yuji
AU  - Ueno Y
FAU - Mori, Akio
AU  - Mori A
FAU - Yanagita, Tomoji
AU  - Yanagita T
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Antipruritics)
RN  - 0 (Morphinans)
RN  - 0 (Spiro Compounds)
RN  - 25CC4N0P8J (TRK 820)
SB  - IM
MH  - Antipruritics/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Morphinans/*therapeutic use
MH  - *Renal Dialysis
MH  - Spiro Compounds/*therapeutic use
MH  - Substance-Related Disorders/*diagnosis
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Uremia/*drug therapy
EDAT- 2013/09/18 06:00
MHDA- 2014/01/17 06:00
CRDT- 2013/09/18 06:00
PHST- 2013/10/23 00:00 [accepted]
PHST- 2013/09/18 06:00 [entrez]
PHST- 2013/09/18 06:00 [pubmed]
PHST- 2014/01/17 06:00 [medline]
AID - 10871 [pii]
AID - 10.5414/CP201852 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2013 Nov;51(11):823-31. doi: 10.5414/CP201852.