Substance Use Clinical Trial
Official title:
Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | November 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | RESTORE Laboratory | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Lapse | Time to first use (CC and/or ECIG) | Week 9 of participation | |
Primary | Nicotine Relapse | 7th day on which CC or ECIG occurs | Week 9 of participation | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Lapse | Time to first use (CC and/or ECIG) | Week 11 of participation | |
Secondary | Nicotine Relapse | 7th day on which CC or ECIG occurs | Week 11 of participation |
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