Dual Use Approach Bias Training for Nicotine Addiction

NCT05306158 | Completed DMC

• 1 other identifier: PAR-19-309
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoking; Electronic Cigarette Use; Substance Use

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Questionnaire of Smoking Urges-Brief (QSU-Brief)

  Week 1-7, 9, and 11 of participation

• Questionnaire of Vaping Craving

  Week 1-7, 9, and 11 of participation

• Approach Bias

  Weeks 2-5 of participation

• Biochemically-Verified Point Prevalence Abstinence

  Week 11 of participation

• Prolonged Abstinence

  Week 11 of participation

Study Arms (3)

CC+ECIG Condition

EXPERIMENTAL

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

CC Only Condition

ACTIVE COMPARATOR

Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images.

Other: CC Condition

Sham Condition

SHAM COMPARATOR

Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other.

Other: Sham Condition

Interventions

CC+ECIG Condition OTHER

Participants will push CC- and ECIG-related pictures.

CC+ECIG Condition

CC Condition OTHER

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

CC Only Condition

Sham Condition OTHER

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

Also known as: Control

Sham Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

RESTORE Laboratory

Houston, Texas, 77204, United States

Location

Related Publications (1)

• Clausen B, Rinck M, Nizio P, Matoska CT, Zappi C, Smits JAJ, Gallagher MW, Zvolensky MJ, Garey L. Study protocol for approach bias retraining for nicotine addiction among dual combustible and electronic cigarette users. Contemp Clin Trials. 2023 May;128:107145. doi: 10.1016/j.cct.2023.107145. Epub 2023 Mar 9.

  PMID: 36905980 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Vaping; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lorra Garey, Ph.D

  Assistant Research Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: There are three arms, one intervention (CC+ECIG Condition), one active comparator (CC Condition), and one Sham (control) arm which are randomly assigned at the same time (baseline) and are implemented in parallel.

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 31, 2022
• Study Start: October 3, 2022
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after completion upon request.
• Access Criteria: Upon specific IRB approval and request from researchers.

Locations

US (1)