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Completed

NCT Number: NCT05306158

Dual Use Approach Bias Training for Nicotine Addiction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RESTORE Laboratory

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CC+ECIG Condition

Other

Participants will push CC- and ECIG-related pictures.

CC Condition

Other

Participants will push CC-related images and push and pull ECIG-related pictures equally often.

Sham Condition

Other

Participants will pull and push CC- and ECIG-related pictures equally often.

Other names: Control

Primary outcomes

  1. Biochemically-Verified Point Prevalence Abstinence

    Time frame: 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)

  2. Prolonged Abstinence

    Time frame: 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)

  3. Lapse

    Time frame: Week 9 of participation

    Time to first use (CC and/or ECIG)

  4. Nicotine Relapse

    Time frame: Week 9 of participation

    7th day on which CC or ECIG occurs

Secondary outcomes

  1. Questionnaire of Smoking Urges-Brief (QSU-Brief)

    Time frame: 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).

  2. Questionnaire of Vaping Craving

    Time frame: 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).

  3. Approach Bias

    Time frame: 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).

  4. Biochemically-Verified Point Prevalence Abstinence

    Time frame: 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)

  5. Prolonged Abstinence

    Time frame: 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)

  6. Lapse

    Time frame: Week 11 of participation

    Time to first use (CC and/or ECIG)

  7. Nicotine Relapse

    Time frame: Week 11 of participation

    7th day on which CC or ECIG occurs

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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