NCT04239235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

January 6, 2020

Last Update Submit

April 22, 2026

Conditions

Opioid Addiction

Keywords

Opioid Medication Assisted TreatmentCommunity Reinforcement Approach and Family Training

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Patient opioid and other substance use

    3 and 12 months after baseline

  • Patient opioid and other substance use

    3 months after baseline

  • Patient and Support Person depression symptoms

    3 months after baseline

  • Patient and Support Person depression symptoms

    12 months after baseline

  • Patient and Support Person anxiety symptoms

    3 months after baseline

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: CRAFT

Control

NO INTERVENTION

This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.

Interventions

CRAFTBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and older
  • on buprenorphine treatment for OUD
  • has an eligible support person that participates
  • and older
  • frequent contact with the patient
  • willing and available to try CRAFT

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Open Door Community Health Centers

Arcata, California, 95521, United States

Location

Lifelong Medical Care

Berkeley, California, 94703, United States

Location

Contra Costa Health Services

Concord, California, 94553, United States

Location

Behavioral Health Services

Gardena, California, 90249, United States

Location

Family Health Centers of San Diego

San Diego, California, 92110, United States

Location

Venice Family Clinic

Venice, California, 90291, United States

Location

Related Publications (1)

  • 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.

    PMID: 32653029DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Karen Osilla, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be told which condition they are in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm RCT where participants are randomly assigned to intervention or control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 27, 2020

Study Start

February 15, 2021

Primary Completion

October 31, 2025

Study Completion

January 31, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)