Implementation of Genomics in Substance Use Disorder Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Toward the Implementation of Genomics in Substance Use Disorder Treatment

Conditions
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Tobacco Use Disorder, Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Genetically-Informed RiskProfile
* Other: Brief Cessation Advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genetically-Informed RiskProfile<br> | Behavioral: Genetically-Informed RiskProfile<br>* 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.<br>|
| Active Comparator: Brief Cessation Advice<br> | Other: Brief Cessation Advice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in use of smoking cessation pharmacotherapy in past 30 days | Participants in both groups will be 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: _____________________) | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up | 
| Change in number of cigarettes smoked per day | Participants in both groups will be 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. | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in readiness to quit smoking (Stage of Change) | Participants in both groups will be assessed on self-reported stage of readiness to quit. The investigators will examine progression to a higher stage of readiness to quit in both groups. | Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up | 
| Change in perceived disease risk | Participants in both groups will be assessed on self-reported perceptions of personal susceptibility to smoking-related diseases. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up | 
| Change in perceived benefits of cessation | Participants in both groups will be assessed on self-reported perceptions of personal health benefits related to quitting smoking. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up | 
| Change in perceived value of cessation treatments | Participants in both groups will be assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up | 
| Change in self-efficacy of cessation | Participants in both groups will be assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation. | Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up | 
| Personal relevance of intervention | Participants in both groups will be assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable. | Immediately following intervention receipt |