Cigarette Smoking
Conditions
Brief summary
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.
Interventions
DRUGNicotine Patch
Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking \<10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked \<10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
DRUGSPECTRUM Nicotine Research Cigarettes (0.07 mg)
For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
BEHAVIORALMCE+
During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes.
BEHAVIORALMCE-
During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Francis McClernon, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* generally healthy (i.e. ambulatory, not currently sick) * interest in quitting smoking * smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for \> 1 year * an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine \> 1000 ng/mL to confirm daily smoking (NicAlert=6)
Exclusion criteria
* inability to attend all required experimental sessions * desire to quit smoking prior to the study quit date * a quit attempt resulting in greater than 3 days of abstinence in the past 30 days * report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems) * unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician) * schizophrenia and schizoaffective disorder * psychiatric medication changes (e.g. new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms * use of other tobacco products or e-cigarettes more than 9 days in the past 30 days * current alcohol or drug abuse * use of illegal drugs (excluding marijuana) or drugs without a valid prescription as measured by urine drug screen * current use of nicotine replacement therapy or other smoking cessation treatment * use of Theophylline for asthma * presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies) * previous participation in a study within the past year involving use of Spectrum cigarettes * systolic BP greater than or equal to 140 (participants failing for blood pressure will be allowed to rescreen once) * diastolic BP greater than or equal to 90 (participants failing for blood pressure will be allowed to rescreen once) * heart rate greater than or equal to 100 (participants failing for heart rate will be allowed to rescreen once) * blood alcohol level \>0.0 (participants failing the blood alcohol screen will be allowed to rescreen once) * pregnant, trying to become pregnant, or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fagerstrom Test of Nicotine Dependence Score | baseline - week 6 | Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent). |
| Number of Participants Who Met Relapse Criteria | week 16 | Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement) | week 1, week 6 | Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6. |
| Change in Number of Cigarettes Smoked Per Day (EXT Response) | week 3, week 6 | Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior. |
| Change in Craving Score During MCE Task (MCE Response) | week 3, week 4, week 5 | Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving) |
| Change in Post-quit Cue-reactivity | baseline ,week 6 | Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6. |
Countries
United States
Participant flow
Recruitment details
This study enrolled adult daily smokers from the Raleigh-Durham region in North Carolina who reported interest in quitting smoking
Pre-assignment details
Eighty-seven participants were enrolled and assessed for eligibility. Thirty-eight of those did not meet inclusion criteria (n=29), or withdrew (n=7) or were lost to contact (n=2) prior to baseline. Forty-nine participants completed the baseline cue-reactivity session and 34 returned for their randomization visit.
Participants by arm
| Arm | Count |
|---|---|
| MCE+ Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. | 17 |
| MCE- (Control) Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Total | MCE- (Control) | MCE+ |
|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 11 | 48.4 years STANDARD_DEVIATION 9.1 | 44.0 years STANDARD_DEVIATION 12.5 |
| Cigarettes per day | 19.41 cigarettes per day STANDARD_DEVIATION 9.35 | 21.88 cigarettes per day STANDARD_DEVIATION 10.21 | 16.94 cigarettes per day STANDARD_DEVIATION 7.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 15 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Fagerstrom Test for Nicotine Dependence (FTND) score | 4.97 units on a scale STANDARD_DEVIATION 2.22 | 5.47 units on a scale STANDARD_DEVIATION 2.12 | 4.47 units on a scale STANDARD_DEVIATION 2.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 11 Participants | 9 Participants |
| Sex: Female, Male Female | 19 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 14 / 17 | 16 / 17 |
| serious Total, serious adverse events | 1 / 17 | 0 / 17 |
Outcome results
Primary
Change in Fagerstrom Test of Nicotine Dependence Score
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
Time frame: baseline - week 6
Population: Number analyzed represents all participants who completed treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCE+ | Change in Fagerstrom Test of Nicotine Dependence Score | .67 score on a scale | Standard Deviation 2.61 |
| MCE- (Control) | Change in Fagerstrom Test of Nicotine Dependence Score | 1.33 score on a scale | Standard Deviation 1.35 |
p-value: 0.39ANOVA
Primary
Number of Participants Who Met Relapse Criteria
Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.
Time frame: week 16
Population: All participants randomized to treatment, and completing at least one treatment session
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MCE+ | Number of Participants Who Met Relapse Criteria | 9 Participants |
| MCE- (Control) | Number of Participants Who Met Relapse Criteria | 11 Participants |
Secondary
Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)
Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6.
Time frame: week 1, week 6
Population: Number in each group represents the number of participants who completed the pretreatment phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCE+ | Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement) | 0 mean difference in UB cigarettes smoked | Standard Deviation 0 |
| MCE- (Control) | Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement) | -1.32 mean difference in UB cigarettes smoked | Standard Deviation 4.56 |
Secondary
Change in Craving Score During MCE Task (MCE Response)
Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)
Time frame: week 3, week 4, week 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MCE+ | Change in Craving Score During MCE Task (MCE Response) | Week 3 average | 14.58 score on a scale | Standard Deviation 24.12 |
| MCE+ | Change in Craving Score During MCE Task (MCE Response) | Week 4 average | 11.88 score on a scale | Standard Deviation 19.67 |
| MCE+ | Change in Craving Score During MCE Task (MCE Response) | Week 5 average | 8.25 score on a scale | Standard Deviation 12.25 |
| MCE- (Control) | Change in Craving Score During MCE Task (MCE Response) | Week 3 average | 0.98 score on a scale | Standard Deviation 2.09 |
| MCE- (Control) | Change in Craving Score During MCE Task (MCE Response) | Week 4 average | 4.29 score on a scale | Standard Deviation 10.15 |
| MCE- (Control) | Change in Craving Score During MCE Task (MCE Response) | Week 5 average | 1.34 score on a scale | Standard Deviation 2.84 |
Secondary
Change in Number of Cigarettes Smoked Per Day (EXT Response)
Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior.
Time frame: week 3, week 6
Population: represents all participants who completed both week 3 and week 6 assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCE+ | Change in Number of Cigarettes Smoked Per Day (EXT Response) | 3.05 mean difference in cigarettes smoked | Standard Deviation 5.34 |
| MCE- (Control) | Change in Number of Cigarettes Smoked Per Day (EXT Response) | -.35 mean difference in cigarettes smoked | Standard Deviation 9.55 |
Secondary
Change in Post-quit Cue-reactivity
Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6.
Time frame: baseline ,week 6
Population: The number of participants analyzed represents those who completed the entire pretreatment phase in each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCE+ | Change in Post-quit Cue-reactivity | 23.2 units on a scale | Standard Deviation 26.3 |
| MCE- (Control) | Change in Post-quit Cue-reactivity | 15.2 units on a scale | Standard Deviation 21 |