Smoking Cessation
Conditions
Keywords
Varenicline, Placebo, Inpatient
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.
Interventions
BEHAVIORALSmoking cessation counseling
Counseling sessions provided by a trained smoking counselor
DRUGPlacebo
Sugar pill without any active medication
DRUGVarenicline
Varenicline (an approved medication for smoking cessation)
Sponsors
Pfizer
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.
Exclusion criteria
\- Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Point Prevalence Abstinence From All Forms of Tobacco | 4 weeks after beginning study | Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control: Sugar Pill Without Any Active Medication Smoking counseling, Placebo: Placebo comparator
Interventions:
* Behavior: smoking counseling
* Drug: placebo (sugar pill without any active medication)
Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study
Placebo: Sugar pill without any active medication | 8 |
| Experimental: Varenicline Smoking counseling, Varenicline: Experimental
Interventions:
* Behavioral: smoking counseling
* Drug: varenicline
Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline
Varenicline: Varenicline (an approved medication for smoking cessation) | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Experimental: Varenicline | Control: Sugar Pill Without Any Active Medication | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 13 | 52 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 9 participants | 8 participants | 17 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 2 / 9 |
Outcome results
Primary
7 Day Point Prevalence Abstinence From All Forms of Tobacco
Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.
Time frame: 4 weeks after beginning study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugar Pill Without Any Active Medication | 7 Day Point Prevalence Abstinence From All Forms of Tobacco | 2 participants |
| Experimental: Varenicline | 7 Day Point Prevalence Abstinence From All Forms of Tobacco | 2 participants |