Implementation of Genomics in Substance Use Disorder Treatment

Smoking Cessation Clinical Trial

Official title:

Toward the Implementation of Genomics in Substance Use Disorder Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768114
• Other study ID #: 201704049
• Secondary ID: K12DA041449
• Status: Completed
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: December 7, 2022

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Substance-Related Disorders
• Tobacco Use Cessation
• Tobacco Use Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
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. "	Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
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.	Immediately following intervention receipt

External Links

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