NCT05206435.

Study name	Methadone‐maintained smokers switching to e‐cigarettes (SHINE)
Methods	RCT Butler Hospital, Providence, Rhode Island, United States, 02906
Participants	Estimated enrolment: 240 Inclusion criteria: moderate to heavy cigarette smokers (10 cigarettes/day for > 1 yr; breath CO > 10 ppm) receiving methadone for ≥ 3 mths & attend at least wkly to receive methadone dose interested in switching to EC or NRT Exclusion criteria: use ECs on > 2 of the past 30 days currently use medications that may reduce smoking (e.g. bupropion, varenicline, NRT) unstable psychiatric conditions near‐daily or daily use of marijuana pregnancy cardiovascular event in the last month, daily medication for asthma or COPD
Interventions	EC: type not stated Arm 1: Electronic cigarettes. Participants in this arm are randomized to receive electronic cigarettes for the 6‐week study period. Electronic cigarettes are provided to replace tobacco cigarettes. Arm 2: Nicotine lozenges. Participants in this arm are randomized to receive nicotine lozenges for the 6‐week study period. Nicotine lozenges are provided to replace tobacco cigarettes.
Outcomes	Baseline, 6 weeks Nicotine exposure (urine) Lung functioning: FVC (changes in Forced Vital Capacity, spirometry); FEV1 (changes in Forced Expiratory Volume (FEV ‐ during the first second), spirometry). FEV1/FVC Smoking behaviour and experiences (self‐report) For complete switchers: Nicotine exposure; lung functioning (FVC, FEV1, FEV1/FVC); smoking behaviour and experiences
Starting date	Study start date: March 31 2022. Estimated study completion date: June 30 2024.
Contact information	Michael Stein, MD 401‐455‐6200, michael_stein@brown.edu Ana Abrantes, PhD 401‐455‐6200, ana_abrantes@brown.edu
Notes	New to 2022 update