Smoking
Conditions
Keywords
smoking lapse behavior, smoking cessation, doxazosin, medication effect on smoking lapse behavior, medication effect on smoking cessation, stress
Brief summary
The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.
Interventions
DRUGDoxazosin 4mg/day
4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
DRUGPlacebo
Placebo
DRUGDoxazosin 8mg/day
8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Sponsors
National Institute on Drug Abuse (NIDA)
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
Yes
Inclusion criteria
* Ages 18-60 * Able to read and write English * Smoker * Motivated to Quit Smoking
Exclusion criteria
* Any significant current medical conditions that would contraindicate smoking * Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse * Positive test results at intake appointment on urine drug screens for illicit drugs * Past 30 day use of psychoactive drugs including anxiolytics and antidepressants * Women who are pregnant or nursing * Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders * Participants who have donated blood within the past 6 weeks * Individuals who are currently taking other medications prescribed for smoking cessation * Specific exclusions for administration of doxazosin or any alpha blocker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency (Min) to Initiate Ad-lib Smoking Session | 0 up to 50 minutes (Delay Period) | Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cigarettes Smoked During Ad-lib Session | 60 minutes (ad-lib smoking period) | Number of cigarettes smoked during the stress and neutral ad-lib smoking period. Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo
Placebo controlled | 11 |
| 4mg/Day doxazosin 4mg/day
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study. | 11 |
| 8mg/Day doxazosin 8mg/day
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study. | 13 |
| Total | 35 |
Baseline characteristics
| Characteristic | Placebo | 4mg/Day | 8mg/Day | Total |
|---|---|---|---|---|
| Age, Continuous | 37.36 years STANDARD_DEVIATION 9.29 | 34.82 years STANDARD_DEVIATION 10.85 | 34.23 years STANDARD_DEVIATION 9.83 | 35.40 years STANDARD_DEVIATION 9.8 |
| Race/Ethnicity, Customized African American | 5 Participants | 1 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 6 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 13 |
| other Total, other adverse events | 4 / 11 | 6 / 11 | 7 / 13 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 13 |
Outcome results
Primary
Latency (Min) to Initiate Ad-lib Smoking Session
Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.
Time frame: 0 up to 50 minutes (Delay Period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Latency (Min) to Initiate Ad-lib Smoking Session | Stress | 11.304 minutes | Standard Error 7.407 |
| Placebo | Latency (Min) to Initiate Ad-lib Smoking Session | Neutral | 23.474 minutes | Standard Error 8.312 |
| 4mg/Day | Latency (Min) to Initiate Ad-lib Smoking Session | Stress | 32.128 minutes | Standard Error 7.494 |
| 4mg/Day | Latency (Min) to Initiate Ad-lib Smoking Session | Neutral | 26.790 minutes | Standard Error 8.41 |
| 8mg/Day | Latency (Min) to Initiate Ad-lib Smoking Session | Stress | 27.557 minutes | Standard Error 6.409 |
| 8mg/Day | Latency (Min) to Initiate Ad-lib Smoking Session | Neutral | 23.776 minutes | Standard Error 7.192 |
Secondary
Number of Cigarettes Smoked During Ad-lib Session
Number of cigarettes smoked during the stress and neutral ad-lib smoking period. Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.
Time frame: 60 minutes (ad-lib smoking period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Cigarettes Smoked During Ad-lib Session | Stress | 3.331 number of cigarettes | Standard Error 0.563 |
| Placebo | Number of Cigarettes Smoked During Ad-lib Session | Neutral | 2.139 number of cigarettes | Standard Error 0.397 |
| 4mg/Day | Number of Cigarettes Smoked During Ad-lib Session | Stress | 1.890 number of cigarettes | Standard Error 0.561 |
| 4mg/Day | Number of Cigarettes Smoked During Ad-lib Session | Neutral | 1.866 number of cigarettes | Standard Error 0.396 |
| 8mg/Day | Number of Cigarettes Smoked During Ad-lib Session | Stress | 1.813 number of cigarettes | Standard Error 0.493 |
| 8mg/Day | Number of Cigarettes Smoked During Ad-lib Session | Neutral | 1.688 number of cigarettes | Standard Error 0.348 |