Electronic Cigarette Use, Substance Use, Tobacco Smoking
Conditions
Brief summary
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
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.
Interventions
OTHERCC+ECIG Condition
Participants will push CC- and ECIG-related pictures.
OTHERCC Condition
Participants will push CC-related images and push and pull ECIG-related pictures equally often.
OTHERSham Condition
Participants will pull and push CC- and ECIG-related pictures equally often.
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Abstinence | Week 9 of participation | Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG) |
| Lapse | Week 9 of participation | Time to first use (CC and/or ECIG) |
| Nicotine Relapse | Week 9 of participation | 7th day on which CC or ECIG occurs |
| Biochemically-Verified Point Prevalence Abstinence | Week 9 of participation | Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Abstinence | Week 11 of participation | Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG) |
| Questionnaire of Smoking Urges-Brief (QSU-Brief) | Week 1-7, 9, and 11 of participation | 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). |
| Nicotine Relapse | Week 11 of participation | 7th day on which CC or ECIG occurs |
| Lapse | Week 11 of participation | Time to first use (CC and/or ECIG) |
| Questionnaire of Vaping Craving | Week 1-7, 9, and 11 of participation | 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). |
| Approach Bias | Weeks 2-5 of participation | 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). |
| Biochemically-Verified Point Prevalence Abstinence | Week 11 of participation | Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG) |
Countries
United States
Outcome results
None listed