Smoking
Conditions
Keywords
smoking lapse behavior, guanfacine
Brief summary
The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.
Interventions
DRUGguanfacine
3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.
DRUGplacebo
placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Office of Research on Women's Health (ORWH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* ages 18-60 * able to read and write in English * smokers
Exclusion criteria
* any significant current medical conditions that would contraindicate smoking * current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence * positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines * women who are pregnant or nursing * suicidal, homicidal or evidence of severe mental illness * participants prescribed any psychotropic drug in the 30 days prior to study enrollment * blood donation within the past 6 weeks * participants who have engaged in a quit attempt in the past 3 months * specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) \>450 msec for men and QTc\>470 msec for women; known intolerance for guanfacine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency to Initiate Ad-lib Smoking Session | 50 minutes | latency to initiate smoking (in minutes) during a 50-minute period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Guanfacine guanfacine 3mg/day
guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study. | 50 |
| Placebo placebo control
placebo: placebo | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Guanfacine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35.36 years STANDARD_DEVIATION 10.05 | 36.92 years STANDARD_DEVIATION 11.73 | 36.14 years STANDARD_DEVIATION 10.89 |
| Cigarettes per day | 15.44 cigarettes per day STANDARD_DEVIATION 7.58 | 15.12 cigarettes per day STANDARD_DEVIATION 8.11 | 15.28 cigarettes per day STANDARD_DEVIATION 7.845 |
| 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 | 13 Participants | 18 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 28 Participants | 60 Participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 35 / 50 | 12 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Latency to Initiate Ad-lib Smoking Session
latency to initiate smoking (in minutes) during a 50-minute period.
Time frame: 50 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guanfacine | Latency to Initiate Ad-lib Smoking Session | 31.55 minutes | Standard Error 5.3 |
| Placebo | Latency to Initiate Ad-lib Smoking Session | 30.31 minutes | Standard Error 5.44 |