Trial Outcomes & Findings for Implementation of Genomics in Substance Use Disorder Treatment (NCT NCT04768114)

NCT ID: NCT04768114

Last Updated: 2024-01-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

148 participants

Primary outcome timeframe

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

Results posted on

2024-01-03

Participant Flow

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

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
74
74
Overall Study
COMPLETED
69
63
Overall Study
NOT COMPLETED
5
11

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Lost to Follow-up
5
10
Overall Study
Withdrawal by Subject
0
1

Baseline Characteristics

Implementation of Genomics in Substance Use Disorder Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=74 Participants
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.
Total
n=148 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
68 Participants
n=5 Participants
62 Participants
n=7 Participants
130 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
12 Participants
n=7 Participants
18 Participants
n=5 Participants
Sex/Gender, Customized
Female
51 Participants
n=5 Participants
54 Participants
n=7 Participants
105 Participants
n=5 Participants
Sex/Gender, Customized
Male
21 Participants
n=5 Participants
19 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex/Gender, Customized
Trans female / trans w
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Sex/Gender, Customized
Non-binary
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
73 Participants
n=5 Participants
74 Participants
n=7 Participants
147 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
27 Participants
n=5 Participants
25 Participants
n=7 Participants
52 Participants
n=5 Participants
Race (NIH/OMB)
White
45 Participants
n=5 Participants
45 Participants
n=7 Participants
90 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
74 participants
n=5 Participants
74 participants
n=7 Participants
148 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=74 Participants
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.
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at baseline
11 Participants
9 Participants
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at prior to intervention
9 Participants
2 Participants
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at 30-day follow-up
16 Participants
8 Participants
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Self-reported use of any smoking cessation medications at 6-month follow-up
15 Participants
8 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=74 Participants
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.
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at baseline
13.1 cigarettes smoked per day
Standard Deviation 8.2
12.3 cigarettes smoked per day
Standard Deviation 7.7
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at prior to intervention
12.0 cigarettes smoked per day
Standard Deviation 8.5
11.5 cigarettes smoked per day
Standard Deviation 7.5
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at 30-day follow-up
9.2 cigarettes smoked per day
Standard Deviation 8.4
9.7 cigarettes smoked per day
Standard Deviation 7.5
Change in Number of Cigarettes Smoked Per Day
Self-reported cigarettes per day at 6-month follow-up
7.3 cigarettes smoked per day
Standard Deviation 7.3
9.1 cigarettes smoked per day
Standard Deviation 8.1

SECONDARY outcome

Timeframe: 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.

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. "

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=74 Participants
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.
Change in Readiness to Quit Smoking
Baseline, Precontemplation count
16 Participants
22 Participants
Change in Readiness to Quit Smoking
Baseline, Contemplation count
45 Participants
37 Participants
Change in Readiness to Quit Smoking
Baseline, Preparation count
13 Participants
15 Participants
Change in Readiness to Quit Smoking
Baseline, Action count
0 Participants
0 Participants
Change in Readiness to Quit Smoking
Prior to intervention, Precontemplation count
12 Participants
13 Participants
Change in Readiness to Quit Smoking
Prior to intervention, Contemplation count
41 Participants
39 Participants
Change in Readiness to Quit Smoking
Prior to intervention, Preparation count
17 Participants
13 Participants
Change in Readiness to Quit Smoking
Prior to intervention, Action count
1 Participants
1 Participants
Change in Readiness to Quit Smoking
30-day follow-up, Precontemplation count
8 Participants
12 Participants
Change in Readiness to Quit Smoking
30-day follow-up, Contemplation count
37 Participants
36 Participants
Change in Readiness to Quit Smoking
30-day follow-up, Preparation count
22 Participants
13 Participants
Change in Readiness to Quit Smoking
30-day follow-up, Action count
4 Participants
4 Participants
Change in Readiness to Quit Smoking
6-month follow-up, Precontemplation count
13 Participants
4 Participants
Change in Readiness to Quit Smoking
6-month follow-up, Contemplation count
29 Participants
43 Participants
Change in Readiness to Quit Smoking
6-month follow-up, Preparation count
16 Participants
9 Participants
Change in Readiness to Quit Smoking
6-month follow-up, Action count
10 Participants
7 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=72 Participants
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.
Brief Cessation Advice
n=72 Participants
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.
Change in Perceived Disease Risk
Baseline
4.5 score on a scale
Standard Deviation 0.8
4.3 score on a scale
Standard Deviation 0.8
Change in Perceived Disease Risk
Immediately following intervention receipt
4.7 score on a scale
Standard Deviation 0.7
4.3 score on a scale
Standard Deviation 1.0
Change in Perceived Disease Risk
30-day follow-up
4.6 score on a scale
Standard Deviation 0.6
4.4 score on a scale
Standard Deviation 0.8
Change in Perceived Disease Risk
6-month follow-up
4.6 score on a scale
Standard Deviation 0.8
4.5 score on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=73 Participants
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.
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation at baseline
4.2 score on a scale
Standard Deviation 0.8
4.2 score on a scale
Standard Deviation 0.8
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation immediately following intervention receipt
4.2 score on a scale
Standard Deviation 1.0
4.2 score on a scale
Standard Deviation 0.8
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation at 30-day follow-up
4.6 score on a scale
Standard Deviation 0.7
4.4 score on a scale
Standard Deviation 0.7
Change in Perceived Benefits of Cessation
Self-reported perception of benefits of cessation at 6-month follow-up
4.6 score on a scale
Standard Deviation 0.6
4.4 score on a scale
Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=74 Participants
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.
Change in Perceived Value of Cessation Treatments
Baseline
3.0 score on a scale
Standard Deviation 0.9
3.0 score on a scale
Standard Deviation 0.9
Change in Perceived Value of Cessation Treatments
Immediately following intervention receipt
3.3 score on a scale
Standard Deviation 0.9
2.9 score on a scale
Standard Deviation 0.8
Change in Perceived Value of Cessation Treatments
30-day follow-up
3.2 score on a scale
Standard Deviation 1.0
2.9 score on a scale
Standard Deviation 0.9
Change in Perceived Value of Cessation Treatments
6-month follow-up
3.0 score on a scale
Standard Deviation 1.1
2.8 score on a scale
Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=74 Participants
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.
Brief Cessation Advice
n=74 Participants
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.
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy at baseline
3.5 score on a scale
Standard Deviation 0.9
3.5 score on a scale
Standard Deviation 0.8
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy immediately following intervention receipt
3.6 score on a scale
Standard Deviation 0.7
3.7 score on a scale
Standard Deviation 0.7
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy at 30-day follow-up
3.8 score on a scale
Standard Deviation 1.0
3.9 score on a scale
Standard Deviation 0.8
Change in Self-efficacy of Cessation
Self-reported skill self-efficacy at 6-month follow-up
3.9 score on a scale
Standard Deviation 1.0
3.9 score on a scale
Standard Deviation 0.9
Change in Self-efficacy of Cessation
Self-reported try self-efficacy at baseline
2.6 score on a scale
Standard Deviation 1.0
2.6 score on a scale
Standard Deviation 1.0
Change in Self-efficacy of Cessation
Self-reported try self-efficacy immediately following intervention receipt
2.6 score on a scale
Standard Deviation 1.0
2.6 score on a scale
Standard Deviation 1.0
Change in Self-efficacy of Cessation
Self-reported try self-efficacy at 30-day follow-up
2.8 score on a scale
Standard Deviation 1.2
3.0 score on a scale
Standard Deviation 1.1
Change in Self-efficacy of Cessation
Self-reported try self-efficacy at 6-month follow-up
3.2 score on a scale
Standard Deviation 1.4
3.4 score on a scale
Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Genetically-Informed RiskProfile
n=72 Participants
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.
Brief Cessation Advice
n=66 Participants
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.
Personal Relevance of Intervention
4.5 score on a scale
Standard Deviation 0.6
3.7 score on a scale
Standard Deviation 0.8

Adverse Events

Genetically-Informed RiskProfile

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Brief Cessation Advice

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Genetically-Informed RiskProfile
n=74 participants at risk
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.
Brief Cessation Advice
n=74 participants at risk
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.
Psychiatric disorders
Anxiety
1.4%
1/74 • Adverse events were collected at baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up.
Adverse events were collected when self-reported by participants during the trial.
0.00%
0/74 • Adverse events were collected at baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up.
Adverse events were collected when self-reported by participants during the trial.

Additional Information

Alex T. Ramsey, Ph.D.

Washington University School of Medicine

Phone: 314-362-5370

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place