Recurrence, Smoking Cessation, Substance-Related Disorders
Conditions
Keywords
Relapse, Smoking Cessation, Substance Abuse
Brief summary
This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.
Detailed description
In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.
Interventions
DRUGVarenicline
Varenicline given twice a day or five weeks.
DRUGPlacebo
Placebo given twice a day or five weeks.
Sponsors
Pfizer
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-75 years old * Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake * Contemplating a smoking cessation attempt in the near future * Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion * Able to give informed consent
Exclusion criteria
* Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia * History of attempted suicide or expresses any current suicidal ideation * Pregnant, breast feeding, or planning to become pregnant within the next 3 months * Reports desire for immediate treatment of tobacco/nicotine dependence * Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days to Relapse | 4 weeks | Number of days following the programmed lapse exposure until relapse to smoking occurred |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group given placebo.
Placebo: Varenicline and placebo given twice a day or five weeks. | 50 |
| Varenicline Experimental group given varenicline dosing.
Varenicline: Varenicline and placebo given twice a day or five weeks. | 54 |
| Total | 104 |
Baseline characteristics
| Characteristic | Placebo | Total | Varenicline |
|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 10 | 44 years STANDARD_DEVIATION 11 | 45 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 104 Participants | 54 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 50 participants | 104 participants | 54 participants |
| Sex: Female, Male Female | 20 Participants | 52 Participants | 32 Participants |
| Sex: Female, Male Male | 30 Participants | 52 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 54 |
| other Total, other adverse events | 0 / 50 | 0 / 54 |
| serious Total, serious adverse events | 0 / 50 | 0 / 54 |
Outcome results
Primary
Days to Relapse
Number of days following the programmed lapse exposure until relapse to smoking occurred
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Days to Relapse | 9.1 days | Standard Deviation 9.7 |
| Varenicline | Days to Relapse | 16.4 days | Standard Deviation 10.3 |