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Integrating Support Persons Into Recovery (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239235
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Karen Osilla, RAND

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.

Condition or disease Intervention/treatment Phase
Opioid Addiction Behavioral: CRAFT Not Applicable

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. About 500 patient and SP pairs will be recruited from 12 community health clinics throughout northern and southern California. Patients who are starting 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Official Title: Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
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.

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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Patient opioid and other substance use [ Time Frame: 3 and 12 months after baseline ]
    Days of past month use

  2. Patient opioid and other substance use [ Time Frame: 3 months after baseline ]
    Days of past month use

  3. 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)

  4. 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)

  5. 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)

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient inclusion criteria:

  • 18 and older
  • starting/restarting buprenorphine
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239235


Locations
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United States, California
RAND
Santa Monica, California, United States, 90407
Sponsors and Collaborators
RAND
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Karen Osilla, PhD RAND
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen Osilla, Senior Behavioral Scientist, RAND
ClinicalTrials.gov Identifier: NCT04239235    
Other Study ID Numbers: OBOT-2018C2-12876
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Osilla, RAND:
Opioid Medication Assisted Treatment
Community Reinforcement Approach and Family Training
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders