PMID- 33982141
OWN - NLM
STAT- MEDLINE
DCOM- 20210928
LR  - 20230916
IS  - 1432-2072 (Electronic)
IS  - 0033-3158 (Print)
IS  - 0033-3158 (Linking)
VI  - 238
IP  - 9
DP  - 2021 Sep
TI  - Safety and tolerability of chronic intranasal oxytocin in older men: results from 
      a randomized controlled trial.
PG  - 2405-2418
LID - 10.1007/s00213-021-05862-3 [doi]
AB  - RATIONALE: Most studies evaluating the safety and tolerability of intranasal 
      oxytocin (OT) have not reported consistent adverse events (AEs), but they have 
      largely focused on young men and single-dose administration. Thus, it is unclear 
      whether these findings translate to older individuals and with longer 
      administration periods. OBJECTIVE: Extending previous work, this study 
      investigated the safety and tolerability of chronic intranasal OT in generally 
      healthy older men. METHODS: Data were from a randomized, placebo (P)-controlled, 
      double-blind clinical trial evaluating the effects of 4 weeks of 
      self-administered intranasal OT (24 IU twice daily) in older adults with no major 
      physical or cognitive impairments. Heart rate, blood pressure, urine osmolality, 
      and serum metabolic biomarkers were obtained before and at the end of the 
      intervention. AEs were collected during the first 3 weeks and 1 week after 
      cessation of treatment. RESULTS: Of 103 participants recruited, 95 were 
      randomized and received the intervention (OT = 49, P = 46). OT had no significant 
      impact on cardiovascular, urine, or serum measures. The AEs reported for both 
      treatments were generally mild and few in number, though one participant assigned 
      to OT and two assigned to P dropped out due to AEs. Relative to P, OT did not 
      significantly increase the likelihood of reporting AEs, nor the number or 
      severity of AEs reported. CONCLUSION: Chronic intranasal OT appears safe and 
      well-tolerated in generally healthy older men. These findings provide support for 
      continued human research on potential benefits of chronic OT in older adult 
      populations.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Rung, Jillian M
AU  - Rung JM
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA. rung.jillian@gmail.com.
AD  - Department of Epidemiology, University of Florida, Gainesville, FL, 32611, USA. 
      rung.jillian@gmail.com.
FAU - Horta, Marilyn
AU  - Horta M
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Tammi, Erin M
AU  - Tammi EM
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Perez, Eliany
AU  - Perez E
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Ojeda, Marite C
AU  - Ojeda MC
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Lin, Tian
AU  - Lin T
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Harris, Griffin
AU  - Harris G
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Somerville, Jessie
AU  - Somerville J
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Salmeron, Dinia
AU  - Salmeron D
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA.
FAU - Beltz, Susan E
AU  - Beltz SE
AD  - Investigational Drug Service, University of Florida, Gainesville, FL, USA.
FAU - Sandesara, Bhanuprasad
AU  - Sandesara B
AD  - Department of Aging and Geriatric Research, Institute on Aging, University of 
      Florida, Gainesville, FL, USA.
FAU - Feifel, David
AU  - Feifel D
AD  - Department of Psychiatry, University of California, San Diego, USA.
FAU - Ebner, Natalie C
AU  - Ebner NC
AD  - Department of Psychology, University of Florida, P.O. Box 112250, Gainesville, 
      FL, 32611, USA. natalie.ebner@ufl.edu.
AD  - Department of Aging and Geriatric Research, Institute on Aging, University of 
      Florida, Gainesville, FL, USA. natalie.ebner@ufl.edu.
AD  - Center for Cognitive Aging and Memory, Department of Clinical and Health 
      Psychology, University of Florida, Gainesville, FL, USA. natalie.ebner@ufl.edu.
LA  - eng
GR  - T32AG020499/AG/NIA NIH HHS/United States
GR  - T32DA035167/DA/NIDA NIH HHS/United States
GR  - P30AG028740/Claude D. Pepper Older Americans Independence Center, University of 
      Florida/
GR  - T32 DA035167/DA/NIDA NIH HHS/United States
GR  - P30 AG028740/AG/NIA NIH HHS/United States
GR  - R01 AG059809/AG/NIA NIH HHS/United States
GR  - R01AG059809/AG/NIA NIH HHS/United States
GR  - PRICE-CTSI-IOA ARG DTD 03-26-2008/Center for Cognitive Aging and Memory, 
      University of Florida/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210512
PL  - Germany
TA  - Psychopharmacology (Berl)
JT  - Psychopharmacology
JID - 7608025
RN  - 50-56-6 (Oxytocin)
SB  - IM
MH  - Administration, Intranasal
MH  - Aged
MH  - Double-Blind Method
MH  - Humans
MH  - Male
MH  - *Oxytocin/adverse effects
PMC - PMC8115997
OTO - NOTNLM
OT  - Adverse events
OT  - Aging
OT  - Intranasal administration
OT  - Male
OT  - Oxytocin
OT  - Safety
COIS- The authors declare no competing interests.
EDAT- 2021/05/14 06:00
MHDA- 2021/09/29 06:00
PMCR- 2021/05/12
CRDT- 2021/05/13 06:38
PHST- 2020/07/02 00:00 [received]
PHST- 2021/04/29 00:00 [accepted]
PHST- 2021/05/14 06:00 [pubmed]
PHST- 2021/09/29 06:00 [medline]
PHST- 2021/05/13 06:38 [entrez]
PHST- 2021/05/12 00:00 [pmc-release]
AID - 10.1007/s00213-021-05862-3 [pii]
AID - 5862 [pii]
AID - 10.1007/s00213-021-05862-3 [doi]
PST - ppublish
SO  - Psychopharmacology (Berl). 2021 Sep;238(9):2405-2418. doi: 
      10.1007/s00213-021-05862-3. Epub 2021 May 12.