PMID- 25062287
OWN - NLM
STAT- MEDLINE
DCOM- 20150710
LR  - 20211021
IS  - 1097-9891 (Electronic)
IS  - 0095-2990 (Print)
IS  - 0095-2990 (Linking)
VI  - 41
IP  - 1
DP  - 2015 Jan
TI  - An open-label pilot trial of N-acetylcysteine and varenicline in adult cigarette 
      smokers.
PG  - 52-6
LID - 10.3109/00952990.2014.933839 [doi]
AB  - BACKGROUND: Varenicline (VAR) has demonstrated superior efficacy over other 
      smoking cessation pharmacotherapies, though 50-60% of those treated do maintain 
      abstinence. Some preclinical findings suggest that new nicotine dependence 
      pharmacotherapies should target the glutamatergic system, given its demonstrated 
      role in addiction. Attention has been given to N-acetylcysteine (NAC), which 
      appears to restore normal glutamate signaling in animal models. It is possible 
      that NAC and VAR may work in concert to promote abstinence at higher rates than 
      with either medication alone. OBJECTIVE: To demonstrate the feasibility and 
      safety of co-administering NAC and VAR in nicotine-dependent participants. 
      METHODS: Participants (n = 19) were daily cigarette smokers, and did not need to 
      be seeking treatment. They received 4 weeks of open-label treatment with NAC 
      (1200 mg twice daily) and VAR (1 mg twice daily, following titration) and were 
      assessed weekly for adverse events (AEs), smoking, craving and withdrawal. 
      RESULTS: Sixteen participants reported a total of 40 AEs, and most were mild 
      (88%). The most commonly reported AE was nausea (15%). Medication adherence, 
      assessed via self-reports and pill counts, was excellent (98%). Exploratory 
      analyses showed reductions in cigarettes per day, though point prevalence 
      abstinence at the end of the study was low. CONCLUSIONS: These preliminary data 
      provide the first demonstration of safety and feasibility of the 
      co-administration of NAC and VAR in cigarette smokers. AEs were consistent with 
      those typically reported for VAR and NAC. These data support future efficacy 
      research on NAC and VAR for smoking cessation.
FAU - McClure, Erin A
AU  - McClure EA
AD  - Departments of Psychiatry and Behavioral Sciences .
FAU - Baker, Nathaniel L
AU  - Baker NL
FAU - Gipson, Cassandra D
AU  - Gipson CD
FAU - Carpenter, Matthew J
AU  - Carpenter MJ
FAU - Roper, Amanda P
AU  - Roper AP
FAU - Froeliger, Brett E
AU  - Froeliger BE
FAU - Kalivas, Peter W
AU  - Kalivas PW
FAU - Gray, Kevin M
AU  - Gray KM
LA  - eng
GR  - UL1 TR000062/TR/NCATS NIH HHS/United States
GR  - R25 DA020537/DA/NIDA NIH HHS/United States
GR  - U01 DA031779/DA/NIDA NIH HHS/United States
GR  - U01DA031779/DA/NIDA NIH HHS/United States
GR  - P50DA015369/DA/NIDA NIH HHS/United States
GR  - UL1TR000062/TR/NCATS NIH HHS/United States
GR  - P50 DA015369/DA/NIDA NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20140725
PL  - England
TA  - Am J Drug Alcohol Abuse
JT  - The American journal of drug and alcohol abuse
JID - 7502510
RN  - 0 (Benzazepines)
RN  - 0 (Nicotinic Agonists)
RN  - 0 (Quinoxalines)
RN  - W6HS99O8ZO (Varenicline)
RN  - WYQ7N0BPYC (Acetylcysteine)
SB  - IM
MH  - Acetylcysteine/*administration & dosage/adverse effects
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Benzazepines/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nicotinic Agonists/*administration & dosage/adverse effects
MH  - Pilot Projects
MH  - Quinoxalines/*administration & dosage/adverse effects
MH  - Smoking/*drug therapy
MH  - Smoking Cessation
MH  - Treatment Outcome
MH  - Varenicline
PMC - PMC4262740
MID - NIHMS625337
OTO - NOTNLM
OT  - N-acetylcysteine
OT  - pharmacotherapy
OT  - safety
OT  - smoking cessation
OT  - tolerability
OT  - varenicline
EDAT- 2014/07/26 06:00
MHDA- 2015/07/15 06:00
PMCR- 2015/01/01
CRDT- 2014/07/26 06:00
PHST- 2014/07/26 06:00 [entrez]
PHST- 2014/07/26 06:00 [pubmed]
PHST- 2015/07/15 06:00 [medline]
PHST- 2015/01/01 00:00 [pmc-release]
AID - 10.3109/00952990.2014.933839 [doi]
PST - ppublish
SO  - Am J Drug Alcohol Abuse. 2015 Jan;41(1):52-6. doi: 10.3109/00952990.2014.933839. 
      Epub 2014 Jul 25.