An interventional study of CC+ECIG Condition and CC Condition in Tobacco Smoking, Electronic Cigarette Use and Substance Use, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 107 is close to the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Houston is the lead sponsor of 101 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images.
Other: CC Condition
Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other.
Other: Sham Condition
Participants will push CC- and ECIG-related pictures.
Participants will push CC-related images and push and pull ECIG-related pictures equally often.
Participants will pull and push CC- and ECIG-related pictures equally often.
Also known as: Control
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)
Time frame: 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)
Time frame: Week 9 of participation
Lapse
Time to first use (CC and/or ECIG)
Time frame: Week 9 of participation
Nicotine Relapse
7th day on which CC or ECIG occurs
Time frame: Week 9 of participation
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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Week 11 of participation
Lapse
Time to first use (CC and/or ECIG)
Time frame: Week 11 of participation
Nicotine Relapse
7th day on which CC or ECIG occurs
Time frame: Week 11 of participation
Plan to share: Yes — We will provide de-identified data from this project to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome paper). These data will be provided in digital format (i.e., disk) with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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