Dual Use Approach Bias Training for Nicotine Addiction

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306158
• Other study ID #: PAR-19-309
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: September 2023

Study information

• Verified date: December 2022
• Source: University of Houston
• Contact: Lorra Garey, Ph.D
• Phone: 713-743-8056
• Email: llgarey[@]uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Substance Use
• Substance-Related Disorders
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Other:
• CC+ECIG Condition
Participants will push CC- and ECIG-related pictures.
• CC Condition
Participants will push CC-related images and push and pull ECIG-related pictures equally often.
• Sham Condition
Participants will pull and push CC- and ECIG-related pictures equally often.

Locations

Country	Name	City	State
United States	RESTORE Laboratory	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Lapse	Time to first use (CC and/or ECIG)	Week 9 of participation
Primary	Nicotine Relapse	7th day on which CC or ECIG occurs	Week 9 of participation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Lapse	Time to first use (CC and/or ECIG)	Week 11 of participation
Secondary	Nicotine Relapse	7th day on which CC or ECIG occurs	Week 11 of participation