Integrating Support Persons Into Recovery

Study Overview
=================
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.

Official Title
-----------------
Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care

Conditions
-----------------
Opioid Addiction

Intervention / Treatment
-----------------
* Behavioral: CRAFT


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm RCT where participants are randomly assigned to intervention or control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person. | Behavioral: CRAFT<br>* 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.<br>|
| No Intervention: Control<br>This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient opioid and other substance use | Days of past month use | 3 and 12 months after baseline | 
| Patient opioid and other substance use | Days of past month use | 3 months after baseline | 
| 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) | 3 months after baseline | 
| 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) | 12 months after baseline | 
| 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) | 3 months after baseline | 
| 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) | 12 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid Medication Assisted Treatment, Community Reinforcement Approach and Family Training