Dual Use Approach Bias Training for Nicotine Addiction

Study Overview
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Brief Summary
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The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.

Detailed Description
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The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.

Official Title
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Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users

Conditions
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Tobacco Smoking, Electronic Cigarette Use, Substance Use

Intervention / Treatment
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* Other: CC+ECIG Condition
* Other: CC Condition
* Other: Sham Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age At least 15 days of CC use for the previous month ECIG use with nicotine at least 15 days for the previous month Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale) Ability to speak and read English fluently Not have decreased number of cigarettes by more than half in the past month Own an android smartphone (for EMA). Exclusion Criteria: Current psychotherapy or pharmacotherapy for mental illness or addiction Current use of nicotine replacement therapy, Zyban, or Chantix Limited mental capacity or inability to provide informed consent Insufficient command of the English language (>6th grade English literacy level required)

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are three arms, one intervention (CC+ECIG Condition), one active comparator (CC Condition), and one Sham (control) arm which are randomly assigned at the same time (baseline) and are implemented in parallel.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC+ECIG Condition<br>Combustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images. | Other: CC+ECIG Condition<br>* Participants will push CC- and ECIG-related pictures.<br>|
| Active Comparator: CC Only Condition<br>Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images. | Other: CC Condition<br>* Participants will push CC-related images and push and pull ECIG-related pictures equally often.<br>|
| Sham Comparator: Sham Condition<br>Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other. | Other: Sham Condition<br>* Participants will pull and push CC- and ECIG-related pictures equally often.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically-Verified Point Prevalence Abstinence | Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG) | Week 9 of participation | 
| Prolonged Abstinence | Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG) | Week 9 of participation | 
| Lapse | Time to first use (CC and/or ECIG) | Week 9 of participation | 
| Nicotine Relapse | 7th day on which CC or ECIG occurs | Week 9 of participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Smoking Urges-Brief (QSU-Brief) | The Brief Questionnaire of Smoking Urges (QSU-Brief) consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). | Week 1-7, 9, and 11 of participation | 
| Questionnaire of Vaping Craving | The Questionnaire of Vaping Craving is a modified measure of the QSU and consists of 10 statements about the respondent's feelings and thoughts about his or her desire to vape as he or she is completing the questionnaire (i.e., right now). | Week 1-7, 9, and 11 of participation | 
| Approach Bias | The approach-avoidance task (AAT) is a 15-minute computerized task instructs participants to use a joystick to either pull toward themselves or push away from themselves images presented on the screen that vary in content (i.e., substance-related, neutral, positive) and format (e.g., right- or left-tilted). | Weeks 2-5 of participation | 
| Biochemically-Verified Point Prevalence Abstinence | Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG) | Week 11 of participation | 
| Prolonged Abstinence | Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG) | Week 11 of participation | 
| Lapse | Time to first use (CC and/or ECIG) | Week 11 of participation | 
| Nicotine Relapse | 7th day on which CC or ECIG occurs | Week 11 of participation |