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Integrating Support Persons Into Recovery (INSPIRE)

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ClinicalTrials.gov Identifier: NCT04239235
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : June 29, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Karen Osilla, Stanford University

Tracking Information
First Submitted Date  ICMJE January 6, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE February 15, 2021
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Patient buprenorphine retention [ Time Frame: 6 months after baseline ]
    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 [ Time Frame: 12 months after baseline ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Patient opioid and other substance use [ Time Frame: 3 and 12 months after baseline ]
    Days of past month use
  • Patient opioid and other substance use [ Time Frame: 3 months after baseline ]
    Days of past month use
  • Patient and Support Person depression symptoms [ Time Frame: 3 months after baseline ]
    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 [ Time Frame: 12 months after baseline ]
    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 [ Time Frame: 3 months after baseline ]
    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 [ Time Frame: 12 months after baseline ]
    severity of anxiety (GAD-7, Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, and severe anxiety)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrating Support Persons Into Recovery
Official Title  ICMJE Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Supportive Care
Condition  ICMJE Opioid Addiction
Intervention  ICMJE Behavioral: CRAFT
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.
Study Arms  ICMJE
  • Experimental: Intervention
    Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
    Intervention: Behavioral: CRAFT
  • No Intervention: Control
    This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Karen Osilla, PhD 3103930411 kosilla@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04239235
Other Study ID Numbers  ICMJE OBOT-2018C2-12876
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karen Osilla, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Karen Osilla, PhD Stanford University
PRS Account Stanford University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP