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Integrating Support Persons Into Recovery (INSPIRE)

Stanford University logo

Stanford University

Status

Active, not recruiting

Conditions

Opioid Addiction

Treatments

Behavioral: CRAFT

Study type

Interventional

Funder types

Other

Identifiers

NCT04239235
IRB-62016

Details and patient eligibility

About

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.

Full 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.

Enrollment

422 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

422 participants in 2 patient groups

Intervention
Experimental group
Description:
Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
Treatment:
Behavioral: CRAFT
Control
No Intervention group
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.

Trial contacts and locations

6

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Central trial contact

Karen Osilla, PhD; Katherine Nameth

Data sourced from clinicaltrials.gov

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