Implementation of Genomics in Substance Use Disorder Treatment
Toward the Implementation of Genomics in Substance Use Disorder Treatment
2 other identifiers
interventional
148
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedStudy Start
First participant enrolled
March 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2022
CompletedResults Posted
Study results publicly available
January 3, 2024
CompletedJanuary 3, 2024
December 1, 2023
1.7 years
February 11, 2021
November 21, 2023
December 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Change in Readiness to Quit Smoking
Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
Change in Perceived Disease Risk
Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
Change in 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
Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
Change in Self-efficacy of Cessation
Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
- +1 more secondary outcomes
Study Arms (2)
Genetically-Informed RiskProfile
EXPERIMENTALBrief Cessation Advice
ACTIVE COMPARATORInterventions
* 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.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Smoked combustible cigarettes in past 30 days
- Computer access for remote-based study visits
You may not qualify if:
- Younger than 18 years of age
- No computer access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alex T. Ramsey, Ph.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Alex T Ramsey, Ph.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
February 24, 2021
Study Start
March 19, 2021
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Last Updated
January 3, 2024
Results First Posted
January 3, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Plan to publish within 12 months of ending data collection.
- 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.
* 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.