Pilot Testing the Check Up

Status Recruiting

Clinical Trial Summary

We propose to pilot test an adapted version of the Teen Marijuana Check Up (TMCU) for persistent cannabis users with first episode psychosis (FEP) in Coordinated Specialty Care (CSC). The adapted version of the TMCU will include tailoring to risks of persistent cannabis use in FEP, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use.

Clinical Trial Description

We propose to adapt the Teen Marijuana Check Up for persistent cannabis users with FEP in CSC. Dr. Walker, the developer of the TMCU, will be a consultant. Adaptations will include tailoring content of assessment and feedback to risks of persistent cannabis use in FEP, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use. We will also develop guidelines for integrating continued collaborative, harm-reduction focused discussion of cannabis use into CSC, consider adding booster or check-in sessions, and specify how family members can be brought into the check-up process. To inform these adaptations, we will collect quantitative data from cannabis-using FEP patients (n of 40) and conduct qualitative interviews with cannabis-using patients, family members, and CSC clinicians (15 of each) about their perspectives on cannabis use and CSC participation (Aim 1). We will use these data as part of an iterative process to specify the adapted intervention that will integrate information gathered from team discussion and focus groups with FEP patients and family members and vetting of intervention components by key stakeholders (Aim 2). Finally, we will conduct a pilot of the adapted intervention (n of 40 cannabis-using FEP patients compared to matched controls) to examine feasibility, acceptability, fidelity, and preliminary impact on intervention targets and outcomes (Aim 3). If results are promising, the intervention can be tested in a large RCT across the EPINET. ;

Study Design

Related Conditions & MeSH terms

Cannabis Use Disorder

Clinical Trial Details

NCT number	NCT04624074
Study type	Interventional
Source	University of Maryland, Baltimore
Contact	Melanie Bennett, PhD
Phone	410-706-0892
Email	mbennett@som.umaryland.edu
Status	Recruiting
Phase	N/A
Start date	January 1, 2021
Completion date	June 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.