Dianicline, a novel α4β2 nicotinic acetylcholine receptor partial agonist, for smoking cessation: a randomized placebo-controlled clinical trial.
BACKGROUND
Dianicline is a α4β2 nicotinic acetylcholine receptor partial agonist, a class of drugs that includes varenicline and cytisine. Varenicline is efficacious for smoking cessation, while cytisine has not been studied systematically. The efficacy of dianicline has not been previously tested in an adequately powered study.


METHODS
In a randomized, double-blind, parallel group placebo-controlled trial, 602 generally healthy cigarette smokers were assigned to dianicline (n = 300) or placebo (n = 302) for 7 weeks followed by a 19-week off drug follow-up period.


RESULTS
Exhaled carbon monoxide and cotinine-confirmed continuous abstinence rates for Weeks 4-7 were 24.0% for dianicline versus 20.5% for placebo (odds ratio 1.22; 95% CI, 0.83-1.80; p = .307). For Weeks 4-26, the abstinence rates were 16.7% for dianicline versus 13.9% for placebo (odds ratio 1.24; 95% CI, 0.79-1.93; p = .366). Craving for a cigarettes was reduced by dianicline compared with placebo after 7 weeks (p = .0175). Nicotine withdrawal symptoms measured by the Hughes and Hatsukami Minnesota Withdrawal Scale were lower for dianicline compared with placebo in the first 3 weeks of treatment during which time quit rates were also higher in the dianicline-treated group.


CONCLUSIONS
Dianicline did not increase cigarette smoking abstinence rates beyond the initial phase of treatment. However, self-reported craving and nicotine withdrawal symptoms were reduced.
Department of Preventive Cardiology, Oslo University Hospital Ullevål, Oslo, Norway. stonstad@llu.edu
Serena
S
Tonstad
Ingar
I
Holme
Philip
P
Tønnesen
D000328:Adult; D001381:Azepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006576:Heterocyclic Compounds, 4 or More Rings / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D010919:Placebos; D011978:Receptors, Nicotinic / Q000378:metabolism*; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*
D001381:Azepines; D006576:Heterocyclic Compounds, 4 or More Rings; D018722:Nicotinic Agonists; D010919:Placebos; D011978:Receptors, Nicotinic; C403531:nicotinic receptor alpha4beta2; C475773:dianicline