Dual Use Approach Bias Training for Nicotine Addiction

Not Applicable

Completed

• Conditions: Tobacco Smoking; Electronic Cigarette Use; Substance Use

• Registration Number: NCT05306158
• Lead Sponsor: University of Houston

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.

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-10-03
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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)
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).
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).
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)
Nicotine Relapse	Week 11 of participation	7th day on which CC or ECIG occurs

Trial Locations

Locations (1)

RESTORE Laboratory; 🇺🇸 Houston, Texas, United States