Implementation of Genomics in Substance Use Disorder Treatment

Toward the 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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use Disorder; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Genetically-Informed RiskProfile; Other: Brief Cessation Advice

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 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.	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	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. "	Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	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 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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Immediately following intervention receipt

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Alex T Ramsey, Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 201704049; K12DA041449 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Plan to publish within 12 months of ending data collection.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No