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Integrating Support Persons Into Recovery

Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04239235
Acronym
INSPIRE
Enrollment
439
Registered
2020-01-27
Start date
2021-02-15
Completion date
2026-01-31
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Addiction

Keywords

Opioid Medication Assisted Treatment, Community Reinforcement Approach and Family Training

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.

Interventions

BEHAVIORALCRAFT

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.

Sponsors

Stanford University
Lead SponsorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Participants will be told which condition they are in.

Intervention model description

Two-arm RCT where participants are randomly assigned to intervention or control.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Patient buprenorphine retention6 months after baselinePercentage 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

Secondary

MeasureTime frameDescription
Patient opioid and other substance use3 and 12 months after baselineDays of past month use
Patient and Support Person depression symptoms3 months after baselineseverity 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 symptoms3 months after baselineseverity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKaren Osilla, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026