Dual Use Approach Bias Training for Nicotine Addiction

University of Houston

Status: Completed

Conditions: Substance Use; Electronic Cigarette Use; Tobacco Smoking

Treatments: Other: CC+ECIG Condition; Other: CC Condition; Other: Sham Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT05306158

PAR-19-309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

CC+ECIG Condition

Experimental group

Description:

Combustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images.

Treatment:

Other: CC+ECIG Condition

CC Only Condition

Active Comparator group

Description:

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

Treatment:

Other: CC Condition

Sham Condition

Sham Comparator group

Description:

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

Treatment:

Other: Sham Condition