Clinical trial NCT05306158: Dual Use Approach Bias Training for Nicotine Addiction
Official title: Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Electronic Cigarette Use
Substance Use
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Biochemically-Verified Point Prevalence Abstinence
timeFrame: Week 9 of participation
measure: Prolonged Abstinence
timeFrame: Week 9 of participation
measure: Lapse
timeFrame: Week 9 of participation
measure: Nicotine Relapse
timeFrame: Week 9 of participation
Secondary outcomes:
measure: Questionnaire of Smoking Urges-Brief (QSU-Brief)
timeFrame: Week 1-7, 9, and 11 of participation
measure: Questionnaire of Vaping Craving
timeFrame: Week 1-7, 9, and 11 of participation
measure: Approach Bias
timeFrame: Weeks 2-5 of participation
measure: Biochemically-Verified Point Prevalence Abstinence
timeFrame: Week 11 of participation
measure: Prolonged Abstinence
timeFrame: Week 11 of participation
measure: Lapse
timeFrame: Week 11 of participation
measure: Nicotine Relapse
timeFrame: Week 11 of participation
Other outcomes:
Locations:
city: Houston
country: United States
facility: RESTORE Laboratory
state: Texas
Study officials:
affiliation: Assistant Research Professor
name: Lorra Garey, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: