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Implementation of Genomics in Substance Use Disorder Treatment

Toward the Implementation of Genomics in Substance Use Disorder Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04768114
Enrollment
148
Registered
2021-02-24
Start date
2021-03-19
Completion date
2022-12-07
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Tobacco Use Cessation, Tobacco Use Disorder

Brief summary

Cigarette smoking remains one of the leading causes of preventable death. Effective smoking cessation medications exist but use of these treatments is low, making it difficult for most to quit smoking. Behavioral interventions are needed to engage current smokers in the process of quitting smoking and promote the use of evidence-based cessation medications. At the same time, genetics influences one's smoking behaviors (e.g., how much they smoke, difficulty quitting) and risk of smoking-related diseases, yet these personalized factors have not been included in existing behavioral interventions. Incorporating these individualized factors into smoking cessation interventions may make them more personally engaging and thus motivating for treatment. This study will pilot test a risk communication tool that is personalized to one's genetics and will demonstrate the feasibility of a larger trial to test the effect of this personalized genetically-informed intervention on smoking cessation.

Interventions

BEHAVIORALGenetically-Informed RiskProfile

* Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change. * This is a fully remote trial, with intervention delivered via video conferencing.

* Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed. * This is a fully remote trial, with brief cessation advice delivered via video conferencing.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* At least 18 years of age * Smoked combustible cigarettes in past 30 days * Computer access for remote-based study visits

Exclusion criteria

* Younger than 18 years of age * No computer access

Design outcomes

Primary

MeasureTime frameDescription
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysBaseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were asked about their use of several smoking cessation medications (Question: In the past 30 days, have you used any of the following prescription medications or over-the-counter aids to help you quit or cut back on smoking?; Response options: 1=Bupropion or Zyban; 2=Varenicline or Chantix; 3=Nicotine patch; 4=Nicotine gum or lozenge; 5=Other (Specify).
Change in Number of Cigarettes Smoked Per DayBaseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were asked In the past 30 days, how many days did you smoke cigarettes and On the days in which you smoked cigarettes in the past month, about how many cigarettes did you smoke. The values from these questions are multiplied together and then divided by 30 (days) to calculate the number of cigarettes smoked per day for each participant.

Secondary

MeasureTime frameDescription
Change in Perceived Benefits of CessationBaseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were assessed on self-reported perceptions of personal health benefits related to quitting smoking. This measure is based on 3 items from the Perceived Risks and Benefits Questionnaire (PRBQ) addressing benefits related to reduced risks of smoking-related diseases, avoidance of future health problems, and increased longevity if the participant were to quit smoking. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Very Unlikely to 5=Very Likely. Individual scores on the 3 items were then averaged together for a total scale range of 1 to 5. A higher score represents higher perceived benefits of cessation.
Change in Perceived Value of Cessation TreatmentsBaseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking. This measure includes 4 items modified from the Beliefs and Attitudes about Buproprion Scale which assesses perceived importance of using medications for smoking cessation, perceived confidence in medications as a smoking cessation aid, general expectancy that smoking cessation medications help people stop smoking, and perceived confidence in being able to use smoking cessation medications within the next month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Extremely. Individual scores on the 4 items were then averaged together for at total scale range of 1-5. A higher score represents a higher perceived value of cessation treatment.
Change in Readiness to Quit SmokingBaseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were assessed on self-reported stage of readiness to quit smoking. This measure includes one item based on the Transtheoretical Model of Change and measured along stages of Precontemplation, Contemplation, Preparation, and Action. (Question: Are you thinking of quitting smoking?; Response options: 1=No, I am not seriously considering quitting within the next 6 months (Precontemplation); 2=Yes, I am seriously considering quitting within the next 6 months (Contemplation); 3=Yes, I am seriously planning to quit within the next 30 days (Preparation); 4=I have quit smoking within the past 6 months (Action). A higher score represents a higher stage of readiness to quit smoking.
Personal Relevance of InterventionImmediately following intervention receiptParticipants in both groups were assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable. This measure includes 4 items modified from the Personal Relevance Scale and addresses the extent to which the intervention helped participants learn something about themselves, the role that their personal characteristics play in their smoking, how smoking affects their life, and the impact on their smoking cessation attempts. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Strongly Disagree to 5=Strongly Agree. Individual scores on the 4 items were then averaged together for a total scale range of 1 to 5. A higher score represents a higher perception of personal relevance of the intervention.
Change in Self-efficacy of CessationBaseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation. This measure is based on 3 items modified from the Skill Self-Efficacy Scale and 3 items modified from the Try Self-Efficacy Scale. Skill self-efficacy items address confidence to solicit social support, avoid situations with a high risk of relapse, and distract oneself when experiencing cravings during a quit attempt. Try self-efficacy items address perceived personal ability to smoke fewer cigarettes a day, resist smoking for one week, and resist smoking for one month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Very. Individual scores on the 3 items were then averaged together for a total scale range of 1-5. A higher score represents a higher perceived self-efficacy of cessation.
Change in Perceived Disease RiskBaseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-upParticipants in both groups were assessed on self-reported perceptions of personal susceptibility to smoking-related diseases. This measure includes one item comprising the perceived susceptibility scale (Question: How likely is it for you to develop a smoking-related disease such as lung cancer or chronic obstructive pulmonary disease (COPD), if you continue to smoke?; Response options: 1=Very unlikely; 2=Somewhat unlikely; 3=Neither unlikely nor likely; 4=Somewhat likely; 5=Very likely). A higher score represents a higher perceived disease risk.

Countries

United States

Participant flow

Recruitment details

The study opened to participant enrollment on 02/08/2021 and closed to participant enrollment on 05/29/2022.

Participants by arm

ArmCount
Genetically-Informed RiskProfile
Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change. This is a fully remote trial, with intervention delivered via video conferencing.
74
Brief Cessation Advice
Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed. This is a fully remote trial, with brief cessation advice delivered via video conferencing.
74
Total148

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up510
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicGenetically-Informed RiskProfileBrief Cessation AdviceTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants12 Participants18 Participants
Age, Categorical
Between 18 and 65 years
68 Participants62 Participants130 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
73 Participants74 Participants147 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
27 Participants25 Participants52 Participants
Race (NIH/OMB)
More than one race
1 Participants4 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
45 Participants45 Participants90 Participants
Region of Enrollment
United States
74 participants74 participants148 participants
Sex/Gender, Customized
Female
51 Participants54 Participants105 Participants
Sex/Gender, Customized
Male
21 Participants19 Participants40 Participants
Sex/Gender, Customized
Non-binary
2 Participants0 Participants2 Participants
Sex/Gender, Customized
Trans female / trans w
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 740 / 74
other
Total, other adverse events
1 / 740 / 74
serious
Total, serious adverse events
0 / 740 / 74

Outcome results

Primary

Change in Number of Cigarettes Smoked Per Day

Participants in both groups were asked In the past 30 days, how many days did you smoke cigarettes and On the days in which you smoked cigarettes in the past month, about how many cigarettes did you smoke. The values from these questions are multiplied together and then divided by 30 (days) to calculate the number of cigarettes smoked per day for each participant.

Time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (MEAN)Dispersion
Genetically-Informed RiskProfileChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at baseline13.1 cigarettes smoked per dayStandard Deviation 8.2
Genetically-Informed RiskProfileChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at prior to intervention12.0 cigarettes smoked per dayStandard Deviation 8.5
Genetically-Informed RiskProfileChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at 30-day follow-up9.2 cigarettes smoked per dayStandard Deviation 8.4
Genetically-Informed RiskProfileChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at 6-month follow-up7.3 cigarettes smoked per dayStandard Deviation 7.3
Brief Cessation AdviceChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at 6-month follow-up9.1 cigarettes smoked per dayStandard Deviation 8.1
Brief Cessation AdviceChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at baseline12.3 cigarettes smoked per dayStandard Deviation 7.7
Brief Cessation AdviceChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at 30-day follow-up9.7 cigarettes smoked per dayStandard Deviation 7.5
Brief Cessation AdviceChange in Number of Cigarettes Smoked Per DaySelf-reported cigarettes per day at prior to intervention11.5 cigarettes smoked per dayStandard Deviation 7.5
Primary

Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days

Participants in both groups were asked about their use of several smoking cessation medications (Question: In the past 30 days, have you used any of the following prescription medications or over-the-counter aids to help you quit or cut back on smoking?; Response options: 1=Bupropion or Zyban; 2=Varenicline or Chantix; 3=Nicotine patch; 4=Nicotine gum or lozenge; 5=Other (Specify).

Time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Genetically-Informed RiskProfileChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at baseline11 Participants
Genetically-Informed RiskProfileChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at prior to intervention9 Participants
Genetically-Informed RiskProfileChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at 30-day follow-up16 Participants
Genetically-Informed RiskProfileChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at 6-month follow-up15 Participants
Brief Cessation AdviceChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at 6-month follow-up8 Participants
Brief Cessation AdviceChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at baseline9 Participants
Brief Cessation AdviceChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at 30-day follow-up8 Participants
Brief Cessation AdviceChange in Use of Smoking Cessation Pharmacotherapy in Past 30 DaysSelf-reported use of any smoking cessation medications at prior to intervention2 Participants
Secondary

Change in Perceived Benefits of Cessation

Participants in both groups were assessed on self-reported perceptions of personal health benefits related to quitting smoking. This measure is based on 3 items from the Perceived Risks and Benefits Questionnaire (PRBQ) addressing benefits related to reduced risks of smoking-related diseases, avoidance of future health problems, and increased longevity if the participant were to quit smoking. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Very Unlikely to 5=Very Likely. Individual scores on the 3 items were then averaged together for a total scale range of 1 to 5. A higher score represents higher perceived benefits of cessation.

Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at baseline, immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (MEAN)Dispersion
Genetically-Informed RiskProfileChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation at baseline4.2 score on a scaleStandard Deviation 0.8
Genetically-Informed RiskProfileChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation immediately following intervention receipt4.2 score on a scaleStandard Deviation 1
Genetically-Informed RiskProfileChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation at 30-day follow-up4.6 score on a scaleStandard Deviation 0.7
Genetically-Informed RiskProfileChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation at 6-month follow-up4.6 score on a scaleStandard Deviation 0.6
Brief Cessation AdviceChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation at 6-month follow-up4.4 score on a scaleStandard Deviation 0.7
Brief Cessation AdviceChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation at baseline4.2 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation at 30-day follow-up4.4 score on a scaleStandard Deviation 0.7
Brief Cessation AdviceChange in Perceived Benefits of CessationSelf-reported perception of benefits of cessation immediately following intervention receipt4.2 score on a scaleStandard Deviation 0.8
Secondary

Change in Perceived Disease Risk

Participants in both groups were assessed on self-reported perceptions of personal susceptibility to smoking-related diseases. This measure includes one item comprising the perceived susceptibility scale (Question: How likely is it for you to develop a smoking-related disease such as lung cancer or chronic obstructive pulmonary disease (COPD), if you continue to smoke?; Response options: 1=Very unlikely; 2=Somewhat unlikely; 3=Neither unlikely nor likely; 4=Somewhat likely; 5=Very likely). A higher score represents a higher perceived disease risk.

Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at baseline, immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (MEAN)Dispersion
Genetically-Informed RiskProfileChange in Perceived Disease RiskBaseline4.5 score on a scaleStandard Deviation 0.8
Genetically-Informed RiskProfileChange in Perceived Disease RiskImmediately following intervention receipt4.7 score on a scaleStandard Deviation 0.7
Genetically-Informed RiskProfileChange in Perceived Disease Risk30-day follow-up4.6 score on a scaleStandard Deviation 0.6
Genetically-Informed RiskProfileChange in Perceived Disease Risk6-month follow-up4.6 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Perceived Disease Risk6-month follow-up4.5 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Perceived Disease RiskBaseline4.3 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Perceived Disease Risk30-day follow-up4.4 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Perceived Disease RiskImmediately following intervention receipt4.3 score on a scaleStandard Deviation 1
Secondary

Change in Perceived Value of Cessation Treatments

Participants in both groups were assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking. This measure includes 4 items modified from the Beliefs and Attitudes about Buproprion Scale which assesses perceived importance of using medications for smoking cessation, perceived confidence in medications as a smoking cessation aid, general expectancy that smoking cessation medications help people stop smoking, and perceived confidence in being able to use smoking cessation medications within the next month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Extremely. Individual scores on the 4 items were then averaged together for at total scale range of 1-5. A higher score represents a higher perceived value of cessation treatment.

Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (MEAN)Dispersion
Genetically-Informed RiskProfileChange in Perceived Value of Cessation TreatmentsBaseline3.0 score on a scaleStandard Deviation 0.9
Genetically-Informed RiskProfileChange in Perceived Value of Cessation TreatmentsImmediately following intervention receipt3.3 score on a scaleStandard Deviation 0.9
Genetically-Informed RiskProfileChange in Perceived Value of Cessation Treatments30-day follow-up3.2 score on a scaleStandard Deviation 1
Genetically-Informed RiskProfileChange in Perceived Value of Cessation Treatments6-month follow-up3.0 score on a scaleStandard Deviation 1.1
Brief Cessation AdviceChange in Perceived Value of Cessation Treatments6-month follow-up2.8 score on a scaleStandard Deviation 1
Brief Cessation AdviceChange in Perceived Value of Cessation TreatmentsBaseline3.0 score on a scaleStandard Deviation 0.9
Brief Cessation AdviceChange in Perceived Value of Cessation Treatments30-day follow-up2.9 score on a scaleStandard Deviation 0.9
Brief Cessation AdviceChange in Perceived Value of Cessation TreatmentsImmediately following intervention receipt2.9 score on a scaleStandard Deviation 0.8
Secondary

Change in Readiness to Quit Smoking

Participants in both groups were assessed on self-reported stage of readiness to quit smoking. This measure includes one item based on the Transtheoretical Model of Change and measured along stages of Precontemplation, Contemplation, Preparation, and Action. (Question: Are you thinking of quitting smoking?; Response options: 1=No, I am not seriously considering quitting within the next 6 months (Precontemplation); 2=Yes, I am seriously considering quitting within the next 6 months (Contemplation); 3=Yes, I am seriously planning to quit within the next 30 days (Preparation); 4=I have quit smoking within the past 6 months (Action). A higher score represents a higher stage of readiness to quit smoking.

Time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at prior to intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking30-day follow-up, Precontemplation count8 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingBaseline, Action count0 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking30-day follow-up, Contemplation count37 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingBaseline, Contemplation count45 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking30-day follow-up, Preparation count22 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingPrior to intervention, Precontemplation count12 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking30-day follow-up, Action count4 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingBaseline, Precontemplation count16 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking6-month follow-up, Precontemplation count13 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingPrior to intervention, Contemplation count41 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking6-month follow-up, Contemplation count29 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingBaseline, Preparation count13 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking6-month follow-up, Preparation count16 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingPrior to intervention, Preparation count17 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit Smoking6-month follow-up, Action count10 Participants
Genetically-Informed RiskProfileChange in Readiness to Quit SmokingPrior to intervention, Action count1 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking6-month follow-up, Action count7 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingBaseline, Precontemplation count22 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingBaseline, Contemplation count37 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingBaseline, Preparation count15 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingBaseline, Action count0 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingPrior to intervention, Precontemplation count13 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingPrior to intervention, Contemplation count39 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingPrior to intervention, Action count1 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking30-day follow-up, Precontemplation count12 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking30-day follow-up, Contemplation count36 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking30-day follow-up, Preparation count13 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking30-day follow-up, Action count4 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking6-month follow-up, Precontemplation count4 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking6-month follow-up, Contemplation count43 Participants
Brief Cessation AdviceChange in Readiness to Quit Smoking6-month follow-up, Preparation count9 Participants
Brief Cessation AdviceChange in Readiness to Quit SmokingPrior to intervention, Preparation count13 Participants
Secondary

Change in Self-efficacy of Cessation

Participants in both groups were assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation. This measure is based on 3 items modified from the Skill Self-Efficacy Scale and 3 items modified from the Try Self-Efficacy Scale. Skill self-efficacy items address confidence to solicit social support, avoid situations with a high risk of relapse, and distract oneself when experiencing cravings during a quit attempt. Try self-efficacy items address perceived personal ability to smoke fewer cigarettes a day, resist smoking for one week, and resist smoking for one month. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Not at all to 5=Very. Individual scores on the 3 items were then averaged together for a total scale range of 1-5. A higher score represents a higher perceived self-efficacy of cessation.

Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up

Population: Some participants did not complete assessments at immediately following intervention, 30-day follow-up and 6 month follow-up so that is why the number of participants analyzed at these time points does not match the number of participants enrolled.

ArmMeasureGroupValue (MEAN)Dispersion
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported skill self-efficacy at baseline3.5 score on a scaleStandard Deviation 0.9
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported skill self-efficacy immediately following intervention receipt3.6 score on a scaleStandard Deviation 0.7
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported skill self-efficacy at 30-day follow-up3.8 score on a scaleStandard Deviation 1
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported skill self-efficacy at 6-month follow-up3.9 score on a scaleStandard Deviation 1
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported try self-efficacy at baseline2.6 score on a scaleStandard Deviation 1
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported try self-efficacy immediately following intervention receipt2.6 score on a scaleStandard Deviation 1
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported try self-efficacy at 30-day follow-up2.8 score on a scaleStandard Deviation 1.2
Genetically-Informed RiskProfileChange in Self-efficacy of CessationSelf-reported try self-efficacy at 6-month follow-up3.2 score on a scaleStandard Deviation 1.4
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported try self-efficacy at 6-month follow-up3.4 score on a scaleStandard Deviation 1.2
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported skill self-efficacy at baseline3.5 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported try self-efficacy at baseline2.6 score on a scaleStandard Deviation 1
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported skill self-efficacy immediately following intervention receipt3.7 score on a scaleStandard Deviation 0.7
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported try self-efficacy at 30-day follow-up3.0 score on a scaleStandard Deviation 1.1
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported skill self-efficacy at 30-day follow-up3.9 score on a scaleStandard Deviation 0.8
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported try self-efficacy immediately following intervention receipt2.6 score on a scaleStandard Deviation 1
Brief Cessation AdviceChange in Self-efficacy of CessationSelf-reported skill self-efficacy at 6-month follow-up3.9 score on a scaleStandard Deviation 0.9
Secondary

Personal Relevance of Intervention

Participants in both groups were assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable. This measure includes 4 items modified from the Personal Relevance Scale and addresses the extent to which the intervention helped participants learn something about themselves, the role that their personal characteristics play in their smoking, how smoking affects their life, and the impact on their smoking cessation attempts. Response options to individual items were assessed on a 5-point Likert-type scale ranging from 1=Strongly Disagree to 5=Strongly Agree. Individual scores on the 4 items were then averaged together for a total scale range of 1 to 5. A higher score represents a higher perception of personal relevance of the intervention.

Time frame: Immediately following intervention receipt

Population: Some participants did not complete the assessment immediately following intervention so that is why the number of participants analyzed does not match the number of participants enrolled.

ArmMeasureValue (MEAN)Dispersion
Genetically-Informed RiskProfilePersonal Relevance of Intervention4.5 score on a scaleStandard Deviation 0.6
Brief Cessation AdvicePersonal Relevance of Intervention3.7 score on a scaleStandard Deviation 0.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026