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Behavioral Intervention

Genetic Counseling for Mental Health Risks Associated with Cannabis Use (IMAGINE Trial)

N/A
Recruiting
Led By Rudolf Uher, MD, PhD
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capacity to provide informed consent at most recent FORBOW assessment.
Age between 12 and 21 years.
Must not have
A diagnosis of severe mental illness (psychotic disorder, bipolar disorder, severe/recurrent depression) at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study (2 years).
Awards & highlights

Summary

This trialwill look at how genetic counselling can reduce cannabis use & lower risk of severe mental illness.

Who is the study for?
This trial is for English-speaking individuals aged 12-21 who are part of the FORBOW study, can consent to future contact, and have the capacity to give informed consent. It excludes those with severe mental illness, autism, or intellectual disability (IQ < 70).Check my eligibility
What is being tested?
The trial tests if genetic counselling can help young people understand their personal risk of developing severe mental illness due to cannabis use. Participants may learn about their own genetic predisposition towards such risks.See study design
What are the potential side effects?
Genetic counselling is a discussion-based intervention and typically does not involve physical side effects. However, learning about one's genetic risks could potentially cause anxiety or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was able to understand and agree to the study's requirements recently.
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I am between 12 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a severe mental illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of study (2 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of study (2 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-reported cannabis use
Secondary outcome measures
Presence of cannabinoids in urine
The proportion of participants who complete the intervention after receiving an offer to participate (intervention acceptability)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Genetic counsellingExperimental Treatment1 Intervention
Eligible participants who are randomized will be contacted and offered an invitation to attend the intervention. Genetic counselling will be provided to participants who accept the intervention as a single 1-2 hour session by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype at rs2494732. Participants will be counselled regarding their individualized risk of developing and of NOT developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if they accept the genetic test results). Approximately 1 month after the intervention, participants will receive a follow-up interview.
Group II: Control groupActive Control1 Intervention
Eligible participants who are not randomized to be offered the intervention will continue with their annual assessments as part of the parent study. These participants will receive the current standard of care (no intervention), and will not be offered or informed of the intervention.

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
264 Previous Clinical Trials
85,796 Total Patients Enrolled
1 Trials studying Psychosis
22 Patients Enrolled for Psychosis
Rudolf Uher, MD, PhDPrincipal InvestigatorNova Scotia Health Authority, Dalhousie University
4 Previous Clinical Trials
30,764 Total Patients Enrolled

Media Library

Genetic counselling (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03601026 — N/A
Psychosis Research Study Groups: Genetic counselling, Control group
Psychosis Clinical Trial 2023: Genetic counselling Highlights & Side Effects. Trial Name: NCT03601026 — N/A
Genetic counselling (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03601026 — N/A
~2 spots leftby Sep 2024