Conditions: Smoking Cessation
Keywords: Varenicline Placebo Inpatient
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: yes

Brief summary:
This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).

Detailed description:
The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization.

Arms:
arm 1: Smoking cessation counseling with placebo comparator arm 2: Smoking cessation counseling with varenicline

Interventions: intervention 1: Smoking cessation counseling intervention 2: Placebo intervention 3: Varenicline
Intervention descriptions: intervention 1: Counseling sessions provided by a trained smoking counselor intervention 2: Sugar pill without any active medication intervention 3: Varenicline (an approved medication for smoking cessation)

Protocol document: