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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

No Placebo-Only Group

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).

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of study (2 years).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-reported cannabis use

Secondary study objectives

Presence of cannabinoids in urine

The proportion of participants who complete the intervention after receiving an offer to participate (intervention acceptability)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met