Allen 2017.

Study name	Reduced nicotine cigarettes in smokers with mood and anxiety disorders
Methods	A 2‐site, 2‐arm, 34‐week, double‐blind, parallel‐group, randomised controlled trial of reduced nicotine cigarettes
Participants	Psychiatric population: adults who smoke and meet lifetime diagnostic criteria for mood or anxiety disorders
Interventions	(a) Usual Nicotine Content (11.6 mg); or (b) Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in 5 steps over 18 weeks. Both arms offered brief smoking cessation counselling after week 10
Outcomes	Primary outcome measure is blood cotinine Key secondary outcomes are: exhaled carbon monoxide; urinary total NNAL‐ 4‐(methylnitrosamino)‐1‐(3‐pyridyl)‐1‐butanol and 1‐hydroxypyrene; oxidative stress biomarkers including 8‐isoprostanes; measures of psychiatric symptoms (e.g., depression, anxiety); smoking behaviour and dependence (e.g., cigarette consumption, quit attempts); and health effects (e.g., blood pressure, respiratory symptoms)
Starting date	Recruitment of participants started in September 2015
Contact information	Name: Sophia Allen; Email: sallen@phs.psu.edu
Notes	Registry ID: Clinicaltrials.gov NCT01928758 Funding source: National Institute on Drug Abuse of the National Institutes of Health under Award Number P50DA036107 (JM & JF PIs for parent grant; JF and AEE PIs for this study) and the Center for Tobacco Products of the U.S. Food and Drug Administration. NIH NIDA (P50DA036107), NCATS (UL1 TR000127), FDA Declaration of interests: JF has done paid consulting for pharmaceutical companies involved in producing smoking cessation medications, including GSK, Pfizer, Novartis, J&J, and Cypress Bioscience, and received a research grant from Pfizer Inc. (not related to reduced nicotine cigarettes). There are no competing interests to declare for other authors