NCT05490927

Brief Summary

The purpose of this study is to examine whether microaggressions relate to multimodal facets of smoking behavior, subjective withdrawal, and urge/craving. Additionally, the second aim is to examine whether smoking deprivation moderates the relation between microaggressions and multiple facets of smoking behavior, subjective withdrawal, and urge/craving.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

June 17, 2022

Last Update Submit

May 21, 2025

Conditions

Keywords

SmokingHispanicLatinx

Outcome Measures

Primary Outcomes (4)

  • Smoking Behaviors

    Smoking behaviors will be operationally defined as smoking topography (e.g., puff behavior) measured via the Clinical Research Support System (CReSS; Plowshare Technologies, Borgwaldt KC, Inc., Virginia).

    During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)

  • Subjective Withdrawal

    The 8-item Minnesota Withdrawal Scale will be used to assesses withdrawal severity. Each of the items are rated on a Likert-type scale ranging from 0 to 4. Items are summed to produce a total score with higher scores indicative of worse outcomes (possible range 0-32).

    During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)

  • Urge/Craving

    Smoking urge/craving will be measured with the 10-item Questionnaire of Smoking Urges-Brief (QSU-B). Each of the items are rated on a Likert-type scale ranging from 1 to 7. Items are summed to create two subscale scores and a total score with higher scores indicative of worse outcomes (possible range 7-70).

    During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)

  • Smoking Lapse Behaviors

    Smoking Lapse Behaviors will be measured during the Relapse Analogue Task (RAT), during which participants are able to delay smoking for a small financial reward. For this task, Smoking Lapse Behaviors are conceptualized as two variables: (a) minutes in time of smoking delay (possible range -50 to +50) and (b) number of cigarettes smoked

    During the Smoking as Usual Visit and Smoking Deprivation Visit (Visits are randomly ordered, counterbalanced separated by ~14 days)

Study Arms (2)

Smoking Deprivation

EXPERIMENTAL

16 hours of smoking abstinence prior to experimental visit.

Behavioral: Microaggression Recall and Relapse Analogue Task

Smoking as Usual

EXPERIMENTAL

Smoking as usual prior to experimental visit.

Behavioral: Microaggression Recall and Relapse Analogue Task

Interventions

Participants will engage in a microaggression recall task followed by the McKee Experimental Relapse Analogue Task

Smoking DeprivationSmoking as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Current regular (daily) cigarette smoking for \>= 1 year
  • Current smoking \>= 5 cig/day and biochemically confirmed via carbon monoxide (CO) analysis
  • Being self-identified as Hispanic or Latino
  • Able to provide written, informed consent
  • Endorsement of at least one microaggression experience over the past 6-months

You may not qualify if:

  • Endorsement of current psychotic symptoms
  • Active suicidality
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

SmokingRacism

Condition Hierarchy (Ancestors)

BehaviorPrejudiceSocial BehaviorSocial Discrimination

Study Officials

  • Brooke Y Kauffman, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Y Kauffman, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 17, 2022

First Posted

August 8, 2022

Study Start

October 13, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations