Tobacco Use DisorderNCT04768114
Implementation of Genomics in Substance Use Disorder Treatment
A study testing Genetically-Informed RiskProfile and Brief Cessation Advice in people with Tobacco Use Disorder and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation, Tobacco Use Cessation
- What is being tested?
- Genetically-Informed RiskProfile and Brief Cessation Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 7 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Smoked combustible cigarettes in past 30 days
- Computer access for remote-based study visits
Who cannot join
- Younger than 18 years of age
- No computer access
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Being tested
- Genetically-Informed RiskProfile, Brief Cessation Advice
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetically-Informed RiskProfileBehavioural
- 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 AdviceOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Genetically-Informed RiskProfile | Experimental | Not described Receives: Behavioral: Genetically-Informed RiskProfile |
| Brief Cessation Advice | Active comparator | Not described Receives: Other: Brief Cessation Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
Secondary outcomes (6)
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. "
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately following intervention receipt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start19 Mar 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alex T Ramsey, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768114
- Sponsor's protocol ID
- 201704049
- Other IDs
- K12DA041449
- Status last verified
- Dec 2023
- First submitted
- 11 Feb 2021
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward the Implementation of Genomics in Substance Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT04768114
- Acronym / sponsor ID
- 201704049
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Posted 3 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetically-Informed RiskProfile | Experimental | Behavioral: Genetically-Informed RiskProfile |
| Brief Cessation Advice | Active comparator | Other: Brief Cessation Advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Smoked combustible cigarettes in past 30 days
- Computer access for remote-based study visits
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- No computer access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Genetically-Informed RiskProfile |
| 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. | Other | Brief Cessation Advice |
Primary outcome
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
Time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
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).
Change in Number of Cigarettes Smoked Per Day
Time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
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.
6 secondary outcomes
Change in Readiness to Quit Smoking
Time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
Change in Perceived Disease Risk
Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
Change in Perceived Benefits of Cessation
Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
Change in Perceived Value of Cessation Treatments
Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
Change in Self-efficacy of Cessation
Time frame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
Personal Relevance of Intervention
Time frame: Immediately following intervention receipt
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. * 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex T Ramsey, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetically-Informed RiskProfile and Brief Cessation Advice in people with Tobacco Use Disorder and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days (time frame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.