Integrating Support Persons Into Recovery

Opioid Addiction Clinical Trial

— INSPIRE  

Official title:

Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239235
• Other study ID #: OBOT-2018C2-12876
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2022
• Source: Stanford University
• Contact: Karen Osilla, PhD
• Phone: 3103930411
• Email: kosilla[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Addiction
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Lifelong Medical Care	Berkeley	California
United States	Contra Costa Health Services	Concord	California
United States	Venice Family Clinic	Venice	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient opioid and other substance use	Days of past month use	3 and 12 months after baseline
Secondary	Patient opioid and other substance use	Days of past month use	3 months after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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