Integrating Support Persons Into Recovery

Not Applicable

Recruiting

• Conditions: Opioid Addiction
• Interventions: Behavioral: CRAFT

• Registration Number: NCT04239235
• Lead Sponsor: Stanford University

Brief 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.

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 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 Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2021-02-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient buprenorphine retention	12 months after baseline	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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Venice Family Clinic; 🇺🇸 Venice, California, United States

Contra Costa Health Services; 🇺🇸 Concord, California, United States

Open Door Community Health Centers; 🇺🇸 Arcata, California, United States

Lifelong Medical Care; 🇺🇸 Berkeley, California, United States

Behavioral Health Services; 🇺🇸 Gardena, California, United States

Family Health Centers of San Diego; 🇺🇸 San Diego, California, United States