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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, mid-intervention (week 4), post-intervention (week 8)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean readiness to change substance use
Secondary outcome measures
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
2016
Completed Phase 3
~8350

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,268 Total Patients Enrolled
153 Trials studying Substance Abuse
707,142 Patients Enrolled for Substance Abuse
Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,614 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers currently enrolling in this experiment?

"Affirmative. The clinicaltrials.gov website corroborates that this medical research project, which was first listed on May 19th 2022, is actively recruiting volunteers. Approximately 80 individuals need to be sourced from one location."

Answered by AI

To what demographic does this experiment appeal?

"This medical experiment is seeking 80 participants aged 18-70, diagnosed with early course psychosis (schizophrenia, schizoaffective disorder, etc.), who have consumed alcohol or cannabis in the past month and are not interested in complete abstinence. Consent must be provided by individuals familiar with the patient's condition and they need to possess a device capable of internet access/video conferencing as well as speak and read English fluently."

Answered by AI

Does the study permit applicants of all ages, including those under 30?

"This research is seeking volunteers who are at least 18 years of age but no older than 70."

Answered by AI

To what extent is the research participant pool participating in this investigation?

"Affirmative. Per information found on clinicaltrials.gov, this medical research is still in the process of recruiting participants. The investigation was initially posted on May 19th 2022 and most recently revisited June 2nd 2022. A total 80 patients need to be recruited at one single healthcare site."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
McLean Hospital
Recent research and studies
clinicaltrials.govStudy
Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study
Julie McCarthy, Ph.D. 2022. "Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) and Substance Use: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05380583.
All > Substance Abuse > Bipolar Disorder
~29 spots leftby Jun 2025
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