Clinical trial NCT04239235: Integrating Support Persons Into Recovery
Official title: Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Addiction
Keywords: Opioid Medication Assisted Treatment
Community Reinforcement Approach and Family Training
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-01-27
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm RCT where participants are randomly assigned to intervention or control.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient buprenorphine retention
timeFrame: 6 months after baseline
measure: Patient buprenorphine retention
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Patient opioid and other substance use
timeFrame: 3 and 12 months after baseline
measure: Patient opioid and other substance use
timeFrame: 3 months after baseline
measure: Patient and Support Person depression symptoms
timeFrame: 3 months after baseline
measure: Patient and Support Person depression symptoms
timeFrame: 12 months after baseline
measure: Patient and Support Person anxiety symptoms
timeFrame: 3 months after baseline
measure: Patient and Support Person anxiety symptoms
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Arcata
country: United States
facility: Open Door Community Health Centers
state: California
city: Berkeley
country: United States
facility: Lifelong Medical Care
state: California
city: Concord
country: United States
facility: Contra Costa Health Services
state: California
city: Gardena
country: United States
facility: Behavioral Health Services
state: California
city: San Diego
country: United States
facility: Family Health Centers of San Diego
state: California
city: Venice
country: United States
facility: Venice Family Clinic
state: California
Study officials:
affiliation: Stanford University
name: Karen Osilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.