Integrating Support Persons Into Recovery (INSPIRE)

Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care

INtegrated Support Persons Into Recovery (INSPIRE) is a 4-year research project that tests whether integrating a patient's support person into a patient's treatment with Buprenorphine/Naloxone can improve outcomes. The study will examine whether a counseling program called CRAFT for a support person, such as a family member, spouse or friend, can improve patient outcomes.

Study Overview

• Status: Recruiting
• Conditions: Opioid Addiction
• Intervention / Treatment: Behavioral: CRAFT

Detailed Description

Opioid use disorders (OUDs) have reached an all-time high and have devastating effects on the individual, family, and community. While medication treatment for OUD saves lives, rates of treatment drop out are very high. In addition, existing OUD treatments neglect the impact of untreated OUD on the family, and ignore the potential role family members and support persons (SPs) could have on encouraging long-term recovery. Incorporating the patient's support system may be an important way to improve treatment retention. The proposed study evaluates a counseling program for concerned family members, spouses, and friends called Community Reinforcement and Family Training (CRAFT), which is successful at engaging and retaining patients in substance use treatment. While promising, no studies have evaluated whether CRAFT can help patients remain on medication treatment for OUD, provided by community health clinics. If effective, this could save lives and help both patient and family member health outcomes. Patient and SP pairs will be recruited from 17 community health clinics throughout northern and southern California. Patients taking OUD medication treatment will be recruited and randomly assign half of the SPs to receive CRAFT; the other half would receive treatment-as-usual. Patients and SPs will be interviewed three and twelve months later to evaluate whether patients with CRAFT SPs stay in OUD treatment longer, and whether patient and SP health outcomes improve.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Osilla, PhD; Phone Number: 3103930411; Email: kosilla@stanford.edu

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94703
      • Recruiting
      • Lifelong Medical Care
      • Contact: Karen Osilla; Phone Number: 310-393-0411; Email: kosilla@stanford.edu
    • Concord, California, United States, 94553
      • Recruiting
      • Contra Costa Health Services
      • Contact: Karen Osilla; Phone Number: 310-393-0411; Email: kosilla@stanford.edu
    • Venice, California, United States, 90291
      • Recruiting
      • Venice Family Clinic
      • Contact: Karen Osilla, PhD; Phone Number: 310-393-0411; Email: kosilla@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patient inclusion criteria:

• 18 and older
• on buprenorphine treatment for OUD
• has an eligible support person that participates

Support person inclusion criteria:

• 18 and older
• frequent contact with the patient
• willing and available to try CRAFT

Patient exclusion criteria:

• < 18 years and older
• not currently receiving buprenorphine
• not able to provide consent

Support person exclusion criteria:

• < 18 years and older
• currently has a problem with heroin or opioid pills
• not able to provide consent
• actively using other substances such that their presence in group would be contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.	Behavioral: CRAFT; CRAFT is an evidence-based and non-confrontational approach for teaching friends/family members strategies to help their loved one reduce/refrain from using substances. It focuses on improving the lives of both the friends/family members and the individual struggling with substance use.
No Intervention: Control; This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient buprenorphine retention	Percentage of patients who initiated OBOT who have at least 6 months of continuous treatment with buprenorphine with no more than a 7-day lapse between prescriptions	6 months after baseline
Patient buprenorphine retention	Percentage of patients who initiated OBOT who have at least 12 months of continuous treatment with buprenorphine with no more than a 7-day lapse between prescriptions	12 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient opioid and other substance use	Days of past month use	3 and 12 months after baseline
Patient opioid and other substance use	Days of past month use	3 months after baseline
Patient and Support Person depression symptoms	severity of depression (PHQ-9, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression)	3 months after baseline
Patient and Support Person depression symptoms	severity of depression (PHQ-9, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression)	12 months after baseline
Patient and Support Person anxiety symptoms	severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)	3 months after baseline
Patient and Support Person anxiety symptoms	severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)	12 months after baseline

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Karen Osilla, PhD, Stanford University

Publications and helpful links

General Publications

• Osilla KC, Becker K, Ecola L, Hurley B, Manuel JK, Ober A, Paddock SM, Watkins KE. Study design to evaluate a group-based therapy for support persons of adults on buprenorphine/naloxone. Addict Sci Clin Pract. 2020 Jul 11;15(1):25. doi: 10.1186/s13722-020-00199-2.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Opioid Medication Assisted Treatment; Community Reinforcement Approach and Family Training
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: OBOT-2018C2-12876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No