| Study name |
Achieving smoking cessation milestones in opioid treatment patients: a randomised 2x2 factorial trial of directly observed and long‐term varenicline |
| Methods |
2 x 2 factorial, placebo‐controlled, RCT |
| Participants |
450 participants, aged > 18, currently smoking at least 5 CPD and > 100 in their lifetime, motivated to quit, receiving methadone or buprenorphine in an opioid treatment programme > 3 months |
| Interventions |
Long‐term varenicline ‐ 24 weeks of standard dose Short‐term varenicline ‐ 12 weeks of standard dose, then matched placebo weeks 13‐24 Directly observed therapy ‐ varenicline from opioid treatment programme nurses at the same time as methadone Self‐administered varenicline |
| Outcomes |
Primary outcomes: initial abstinence (period of > 24 h smoking abstinence), time to lapse, time to relapse (7 consecutive days of self‐reported smoking) Secondary outcomes: durability of tobacco abstinence, validated by exhaled CO at week 28 and week 52, cigarettes smoked/day, nicotine dependence, QoL |
| Starting date |
25 October 2018 |
| Contact information |
Shadi Nahvi, snahvi@montefiore.org |
| Notes |
Study funding: Albert Einstein College of Medicine, NIH, Pfizer, National Institute on Drug Abuse |
