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CRAFT-EP for Psychosis and Substance Use

N/A
Recruiting
Led By Julie M McCarthy, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 4 days per month contact with the client
Be older than 18 years old
Must not have
Family members with lifetime psychotic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, mid-intervention (week 4), post-intervention (week 8)
Awards & highlights

Summary

This trial will test whether CRAFT-EP, a treatment for families experiencing early psychosis and substance use, is effective when delivered over video conferencing.

Who is the study for?
This trial is for individuals aged 18-70 who have used alcohol or cannabis in the past month, are not currently interested in quitting substance use, and have experienced early psychosis within the last six years. Family members concerned about their relative's substance use can participate if they speak English, can consent, and have video conferencing tools.
What is being tested?
The study is testing a program called CRAFT-EP delivered via telehealth to help families dealing with early psychosis and substance use. It compares this approach with typical support methods (TAU) to see which is more effective when conducted through video calls.
What are the potential side effects?
Since this trial involves family training and support rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional or psychological discomfort during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I interact with the client at least 4 days a month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
A family member has a lifelong psychotic disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, mid-intervention (week 4), post-intervention (week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-intervention (week 4), post-intervention (week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean readiness to change substance use
Secondary study objectives
Family Wellbeing: Anxiety
Family Wellbeing: Depression
Family Wellbeing: Relationship
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CRAFT-EP + TAUExperimental Treatment2 Interventions
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).
Group II: Treatment as UsualActive Control1 Intervention
Treatment as Usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAU
2013
Completed Phase 3
~8300

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,296 Total Patients Enrolled
153 Trials studying Substance Abuse
707,200 Patients Enrolled for Substance Abuse
Mclean HospitalLead Sponsor
215 Previous Clinical Trials
21,613 Total Patients Enrolled
Julie M McCarthy, PhDPrincipal InvestigatorMclean Hospital

Media Library

CRAFT-EP Clinical Trial Eligibility Overview. Trial Name: NCT05380583 — N/A
Substance Abuse Research Study Groups: CRAFT-EP + TAU, Treatment as Usual
Substance Abuse Clinical Trial 2023: CRAFT-EP Highlights & Side Effects. Trial Name: NCT05380583 — N/A
CRAFT-EP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05380583 — N/A
~19 spots leftby Jun 2025
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