Clinical trial NCT04768114: Implementation of Genomics in Substance Use Disorder Treatment
Official title: Toward the Implementation of Genomics in Substance Use Disorder Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Smoking Cessation
Tobacco Use Cessation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-02-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Use of Smoking Cessation Pharmacotherapy in Past 30 Days
timeFrame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
measure: Change in Number of Cigarettes Smoked Per Day
timeFrame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
Secondary outcomes:
measure: Change in Readiness to Quit Smoking
timeFrame: Baseline, immediately prior to intervention receipt, 30-day follow-up, and 6-month follow-up
measure: Change in Perceived Disease Risk
timeFrame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
measure: Change in Perceived Benefits of Cessation
timeFrame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
measure: Change in Perceived Value of Cessation Treatments
timeFrame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
measure: Change in Self-efficacy of Cessation
timeFrame: Baseline, immediately following intervention receipt, 30-day follow-up, and 6-month follow-up
measure: Personal Relevance of Intervention
timeFrame: Immediately following intervention receipt
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alex T Ramsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: