Clinical trial NCT06287203: Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults
Official title: Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-01
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age).

Detailed description: There has been tremendous advances in gene identification. From large-scale, well-powered genome wide association studies (GWAS), polygenic scores (PGS) can now be calculated that sum risk alleles across the genome and weight them by their effect size, creating an index of genetic liability for any given individual. But genetic influences are only part of what contributes to substance use disorders; the environment also plays a critical role. Accordingly, understanding the development of substance use outcomes necessitates integrating both genetic and environmental information. The rationale for this line of research is that the integration of genetic and environmental information will provide the foundation for precision medicine, and that the provision of this personalized risk information will help prevent the development of problems and/or allow for earlier intervention before problems have become severe. Our research team is creating a new prevention/intervention program, consisting of an on-line platform for individuals to receive their personalized risk estimates for addiction risk, created by integrating information about their genetic, behavioral, and environmental risk factors followed by information about how to reduce risk.

The investigators are enrolling a sample of emerging adults (18-25 years of age) into a randomized controlled trial consisting of 4 conditions. All four conditions will involve completion of a behavioral/environmental risk survey and the provision of saliva to determine genetic risk. Three active conditions involve individuals receiving their personalized risk estimates, followed by (condition 1) psychoeducation about ways to reduce substance use and associated harm; (condition 2) the on-line CBT-based module to assist with controlling substance use; or (condition 3) a follow-up appointment with a genetic counselor (GC). The fourth condition will be a waitlist control, in which individuals will receive psychoeducation only at the time that the active conditions receive their personalized risk estimates.

At the first time point (T0), participants will be randomly selected into one of four conditions. Participants have an equal chance of being assigned to any one of the conditions. Across all conditions, the investigators will measure substance use and problems at enrollment (T0), at the time of receipt of risk estimates (\~8 weeks later; or at the time other participants receive their results (\~8 weeks later) in the case of control condition) (T1), 1 month (T2), and 3 months (T3) after completion of the program.

After the final survey (T3), participants in the control condition will receive their personalized risk estimates. All participants, regardless of their initial group, will be invited to receive access to the content of conditions in which they did not take part (e.g., online modules, appointment with a genetic counselor).

Findings from this study have great potential to enhance our ability to use precision medicine to prevent the development of substance use disorders and/or intervene earlier in the progression to disorder.

Eligibility criteria: Inclusion Criteria:

* This study is for emerging adults between 18-25 years who reside in the United States. These individuals must also be English-speaking.

Exclusion Criteria:

* Participants will be excluded from the study if they are younger than 18 years old, older than 25 years old, reside outside of the United States, or if they do not provide informed consent. These exclusion criteria have been chosen because we are targeting emerging adults (a particularly risky population in terms of substance use behaviors).

Primary outcomes:
measure: Alcohol Consumption
timeFrame: 3 months
measure: Alcohol Problems
timeFrame: 3 months
measure: Drug Use Problems
timeFrame: 3 months
measure: Readiness to change
timeFrame: 3 months
measure: Future substance use intentions
timeFrame: 3 months
Secondary outcomes:
measure: Worry About Substance Use Disorders
timeFrame: Baseline to 3 months
measure: Perceived Susceptibility
timeFrame: 3 months
measure: Well-Being
timeFrame: 3 months
measure: Anxiety and Depressive Symptoms
timeFrame: Baseline to 3 months
measure: Addiction Risk Program Satisfaction
timeFrame: immediately after the intervention
measure: Feelings About Results
timeFrame: immediately after the intervention
measure: Satisfaction with the Assigned Conditions
timeFrame: 3 months
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Danielle Dick, PhD
role: PRINCIPAL_INVESTIGATOR
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