Implementation of Genomics in Substance Use Disorder Treatment

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.

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.

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: _____________________")

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".

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.

Participants in both groups will be assessed on self-reported perceptions of personal susceptibility to smoking-related diseases.

Participants in both groups will be assessed on self-reported perceptions of personal health benefits related to quitting smoking.

Participants in both groups will be assessed on self-reported perceptions of the importance of using smoking cessation medications to help quit smoking.

Participants in both groups will be assessed on self-reported perceptions of personal ability to engage in activities that promote smoking cessation.

Participants in both groups will be assessed on self-reported perceptions of the extent to which the intervention was personally significant and applicable.

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

Project data will be shared in de-identified form in accordance with NIH policies including the NIH Genomic Data Sharing Policy. The informed consent process will explain policies for sharing de-identified data with other investigators and NIH repositories. Even though the dataset to be shared will be stripped of identifiers prior to release for sharing, there may be the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the individual-level data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to use the data only for research purposes and not attempt to identify any individual participant; (2) a commitment to store the data on a secure server and take necessary precautions to protect the security of the data; and (3) a commitment to destroy the data after analyses are completed.

The investigators will disseminate study findings through manuscripts, presentations, and lay reports. The investigators will make available via publications the steps and programs needed to implement the intervention. The investigators will make the protocols and tools available to other researchers to be used as a model template for interventions bringing genetics to the treatment of other substance use disorders.

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine