NCT04383782

Brief Summary

Chronic cigarette smoking habits often begin in adolescence or early adulthood. 98% of cigarette smokers try their first cigarette before the age of 26. Thus, young adult smokers represent an important target for early smoking cessation intervention. This study tests two interventions designed to increase motivation to quit and decrease smoking behavior. These interventions include: an expectancy challenge approach, which aims to increase negative beliefs about the consequences of smoking; and a behavioral economics approach, which encourages participants to substitute non-smoking behaviors that may still provide reinforcement similar to reinforcement derived from smoking a cigarette.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

May 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

May 7, 2020

Last Update Submit

January 18, 2021

Conditions

Keywords

smoking cessationmotivationoutcome expectanciesbehavioral reinforcers

Outcome Measures

Primary Outcomes (2)

  • Quit attempt

    yes/no, whether or not the participant made a 24-hour (or longer) quit attempt between the date of the main experiment and the date of the 4-week follow-up assessment.

    4-week follow up

  • Motivation to quit

    Contemplation ladder score (range 0-10; higher scores indicate more motivation to quit)

    4-week follow up

Secondary Outcomes (3)

  • Smoking rate

    4-week follow up

  • Outcome expectancies

    4-week follow up

  • Behavioral reinforcers

    4-week follow up

Study Arms (3)

Expectancy Challenge

ACTIVE COMPARATOR

The expectancy challenge intervention will involve two brief videotaped testimonials in which former smokers discuss their experiences with smoking-related health conditions. Participants will be encouraged to reflect back on the content of each video once per week leading up to the follow-up assessment.

Behavioral: Expectancy Challenge

Expectancy Challenge + Behavioral Activation

EXPERIMENTAL

In addition to the expectancy challenge intervention (see Expectancy Challenge condition), participants in the Expectancy Challenge + Behavioral Activation group will also receive a novel behavioral activation intervention. Participants will be presented with brief psychoeducation about behavioral activation, several examples of possible functions of cigarette smoking, and several suggestions of behavioral strategies. All participants will receive the same information, but they will be encouraged to apply the information to their personal circumstances and to consider additional examples of rewarding activities they may engage in over the next four weeks. Participants will also be encouraged to engage in at least one behavioral activation activity each week leading up to the follow-up assessment.

Behavioral: Expectancy Challenge + Behavioral Activation

Neutral Reading

PLACEBO COMPARATOR

The control group will receive neutral reading materials related to the components and structure of a cigarette. The content will be strictly curated so as to avoid inadvertently encouraging or discouraging smoking among participants.

Behavioral: Control

Interventions

Expectancy challenge intervention (see description in study arms).

Expectancy Challenge

Expectancy challenge + behavioral activation interventions (see description in study arms)

Expectancy Challenge + Behavioral Activation
ControlBEHAVIORAL

Neutral reading condition (see description in study arms).

Neutral Reading

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • English fluency
  • Living in the United States
  • Smoked at least 1 cigarette per week during the past month
  • Willing to be contacted for 1-month follow up assessment

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

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
Doctoral Candidate in Clinical Psychology

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

May 22, 2020

Primary Completion

December 7, 2020

Study Completion

January 4, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations