Integrating Support Persons Into Recovery (INSPIRE)
Primary Purpose
Opioid Addiction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRAFT
Sponsored by
About this trial
This is an interventional supportive care trial for Opioid Addiction focused on measuring Opioid Medication Assisted Treatment, Community Reinforcement Approach and Family Training
Eligibility 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 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
Sites / Locations
- Lifelong Medical CareRecruiting
- Contra Costa Health ServicesRecruiting
- Venice Family ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Patient opioid and other substance use
Days of past month use
Patient opioid and other substance use
Days of past month use
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)
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)
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)
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)
Full Information
NCT ID
NCT04239235
First Posted
January 6, 2020
Last Updated
November 2, 2022
Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04239235
Brief Title
Integrating Support Persons Into Recovery
Acronym
INSPIRE
Official Title
Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Addiction
Keywords
Opioid Medication Assisted Treatment, Community Reinforcement Approach and Family Training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm RCT where participants are randomly assigned to intervention or control.
Masking
None (Open Label)
Masking Description
Participants will be told which condition they are in.
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.
Intervention Type
Behavioral
Intervention Name(s)
CRAFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient buprenorphine retention
Description
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
Time Frame
6 months after baseline
Title
Patient buprenorphine retention
Description
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
Time Frame
12 months after baseline
Secondary Outcome Measure Information:
Title
Patient opioid and other substance use
Description
Days of past month use
Time Frame
3 and 12 months after baseline
Title
Patient opioid and other substance use
Description
Days of past month use
Time Frame
3 months after baseline
Title
Patient and Support Person depression symptoms
Description
severity of depression (PHQ-9, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression)
Time Frame
3 months after baseline
Title
Patient and Support Person depression symptoms
Description
severity of depression (PHQ-9, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression)
Time Frame
12 months after baseline
Title
Patient and Support Person anxiety symptoms
Description
severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)
Time Frame
3 months after baseline
Title
Patient and Support Person anxiety symptoms
Description
severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)
Time Frame
12 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Osilla, PhD
Phone
3103930411
Email
kosilla@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Osilla, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lifelong Medical Care
City
Berkeley
State/Province
California
ZIP/Postal Code
94703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Osilla
Phone
310-393-0411
Email
kosilla@stanford.edu
Facility Name
Contra Costa Health Services
City
Concord
State/Province
California
ZIP/Postal Code
94553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Osilla
Phone
310-393-0411
Email
kosilla@stanford.edu
Facility Name
Venice Family Clinic
City
Venice
State/Province
California
ZIP/Postal Code
90291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Osilla, PhD
Phone
310-393-0411
Email
kosilla@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32653029
Citation
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.
Results Reference
derived
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Integrating Support Persons Into Recovery
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