Dual Use Approach Bias Training for Nicotine Addiction

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking; Electronic Cigarette Use; Substance Use
• Intervention / Treatment: Other: CC+ECIG Condition; Other: CC Condition; Other: Sham Condition

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorra Garey, Ph.D; Phone Number: 713-743-8056; Email: llgarey@uh.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Recruiting
      • RESTORE Laboratory
      • Contact: Pam Nizio, BA; Phone Number: 713-743-0123; Email: niziopam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CC+ECIG Condition; 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 will push CC- and ECIG-related pictures.
Active Comparator: CC Only Condition; Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images.	Other: CC Condition; Participants will push CC-related images and push and pull ECIG-related pictures equally often.
Sham Comparator: Sham 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 pull and push CC- and ECIG-related pictures equally often.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Lapse	Time to first use (CC and/or ECIG)	Week 9 of participation
Nicotine Relapse	7th day on which CC or ECIG occurs	Week 9 of participation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Lapse	Time to first use (CC and/or ECIG)	Week 11 of participation
Nicotine Relapse	7th day on which CC or ECIG occurs	Week 11 of participation

Collaborators and Investigators

• Sponsor: University of Houston
• Investigators: Principal Investigator: Lorra Garey, Ph.D, Assistant Research Professor

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: PAR-19-309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: One year after completion upon request.
• IPD Sharing Access Criteria: Upon specific IRB approval and request from researchers.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No