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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 6 months after baseline
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient buprenorphine retention
Secondary study objectives
Patient and Support Person anxiety symptoms
Patient and Support Person depression symptoms
Patient opioid and other substance use

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: 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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,518 Total Patients Enrolled
1 Trials studying Opioid Addiction
47 Patients Enrolled for Opioid Addiction
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,537 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
~95 spots leftby Dec 2025
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