Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

Study Overview
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Brief Summary
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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.

Official Title
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Strengthening Instrumental Extinction to Prevent Smoking Relapse

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Drug: Nicotine Patch
* Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg)
* Behavioral: MCE+
* Behavioral: MCE-


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCE+<br>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. | Drug: Nicotine Patch<br>* 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.<br>* Other names: Nicoderm CQ;Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg)<br>* For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.<br>* Other names: Very Low Nicotine Content Cigarettes;Behavioral: MCE+<br>* 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.<br>|
| Other: MCE- (Control)<br>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. | Drug: Nicotine Patch<br>* 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.<br>* Other names: Nicoderm CQ;Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg)<br>* For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.<br>* Other names: Very Low Nicotine Content Cigarettes;Behavioral: MCE-<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline - week 6 | 
| 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. | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 1, week 6 | 
| 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. | week 3, week 6 | 
| Change in Craving Score During MCE Task (MCE Response) | Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving) | week 3, week 4, week 5 | 
| 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. | baseline ,week 6 |