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Support Person Involvement for Opioid Addiction (INSPIRE Trial)

N/A

Recruiting

Led By Karen Osilla, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

on buprenorphine treatment for OUD

18 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after baseline

Awards & highlights

INSPIRE Trial Summary

This trial is testing whether involving a patient's support person in their Buprenorphine/Naloxone treatment can improve outcomes.

Who is the study for?

This trial is for adults over 18 with Opioid Use Disorder (OUD) who are currently on buprenorphine treatment. They must be willing to try the CRAFT counseling program and have frequent contact with a support person, such as family or friend, who will participate in the study.Check my eligibility

What is being tested?

The INSPIRE project is testing if involving a patient's support person in their recovery process can improve outcomes. It focuses on whether the CRAFT counseling program for supporters enhances the effectiveness of Buprenorphine/Naloxone treatment for OUD.See study design

What are the potential side effects?

While this trial primarily involves counseling techniques rather than medication, participants may experience emotional discomfort or relationship strain during therapy sessions. The medications involved (Buprenorphine/Naloxone) may cause side effects like drowsiness, dizziness, constipation, or withdrawal-like symptoms.

INSPIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently on buprenorphine for opioid use disorder.

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I am 18 years old or older.

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INSPIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient buprenorphine retention

Secondary outcome measures

Patient and Support Person anxiety symptoms

Patient and Support Person depression symptoms

Patient opioid and other substance use

INSPIRE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.

Group II: ControlActive Control1 Intervention

This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,340,822 Total Patients Enrolled

1 Trials studying Opioid Addiction

47 Patients Enrolled for Opioid Addiction

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,996,448 Total Patients Enrolled

Karen Osilla, PhDPrincipal Investigator - Stanford University

Stanford University

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

CRAFT Clinical Trial Eligibility Overview. Trial Name: NCT04239235 — N/A

Opioid Addiction Research Study Groups: Intervention, Control

Opioid Addiction Clinical Trial 2023: CRAFT Highlights & Side Effects. Trial Name: NCT04239235 — N/A

CRAFT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04239235 — N/A

Opioid Addiction Patient Testimony for trial: Trial Name: NCT04239235 — N/A

Frequently Asked Questions

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

Are individuals still eligible to participate in this research endeavor?

"Affirmative. The information on clinicaltrials.gov conveys that the trial is recruiting participants, having been first posted in February 15th 2021 and most recently updated November 2nd 2022. There are 500 individuals required across 3 distinct medical centres to take part in this experiment."

Answered by AI

How many participants are eligible to partake in this research?

"Affirmative. According to clinicaltrials.gov, this medical experiment is enrolling patients as of now. It was initially posted on February 15th 2021 and the latest update occurred November 2nd 2022. The research project needs 500 individuals from three different sites."

Answered by AI