Integrating Support Persons Into Recovery

NCT ID: NCT04239235

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Opioid Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Participants will be told which condition they are in.

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

CRAFT

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

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


* \< 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Karen Osilla

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Osilla, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Open Door Community Health Centers

Arcata, California, United States

Site Status

Lifelong Medical Care

Berkeley, California, United States

Site Status

Contra Costa Health Services

Concord, California, United States

Site Status

Behavioral Health Services

Gardena, California, United States

Site Status

Family Health Centers of San Diego

San Diego, California, United States

Site Status

Venice Family Clinic

Venice, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32653029 (View on PubMed)

Other Identifiers

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IRB-62016

Identifier Type: -

Identifier Source: org_study_id

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