Opioid AddictionINSPIRENCT04239235
Integrating Support Persons Into Recovery
A study testing CRAFT in people with Opioid Addiction, run by Stanford University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Addiction
- What is being tested?
- CRAFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Feb 2021to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Open Door Community Health Centers
Arcata, California, 95521
Lifelong Medical Care
Berkeley, California, 94703
Contra Costa Health Services
Concord, California, 94553
Behavioral Health Services
Gardena, California, 90249
Family Health Centers of San Diego
San Diego, California, 92110
Venice Family Clinic
Venice, California, 90291
About this study
Official title: Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care
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.
Read the 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.
- Conditions
- Opioid Addiction
- Being tested
- CRAFT
- Keywords
- Opioid Medication Assisted Treatment, Community Reinforcement Approach and Family Training
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRAFTBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person. Receives: Behavioral: CRAFT |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months after baseline
Secondary outcomes (6)
Patient opioid and other substance use
Days of past month use
Measured: 3 and 12 months after baseline
Patient opioid and other substance use
Days of past month use
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Feb 2021
- Primary completion31 Oct 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid AddictionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm RCT where participants are randomly assigned to intervention or control.
- Masking
- None (open label)
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karen Osilla, Stanford University
- Investigators
- Karen Osilla, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239235
- Sponsor's protocol ID
- IRB-62016
- Acronym
- INSPIRE
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32653029
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Significant Other-Enhanced OBOT in Primary Care
- ClinicalTrials.gov ID
- NCT04239235
- Acronym / sponsor ID
- INSPIRE / IRB-62016
- Conditions
- Opioid Addiction
- Keywords
- Opioid Medication Assisted Treatment, Community Reinforcement Approach and Family Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm RCT where participants are randomly assigned to intervention or control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CRAFTCommunity Reinforcement Approach and Family Training is a 10-session rolling group for the support person. |
| Control | No intervention | –This condition is for support persons who do not receive CRAFT. They will receive no intervention or usual care services available at the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRAFTCRAFT 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. | Behavioural | Intervention |
Primary outcome
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
6 secondary outcomes
Patient opioid and other substance use
Time frame: 3 and 12 months after baseline
Patient opioid and other substance use
Time frame: 3 months after baseline
Patient and Support Person depression symptoms
Time frame: 3 months after baseline
Patient and Support Person depression symptoms
Time frame: 12 months after baseline
Patient and Support Person anxiety symptoms
Time frame: 3 months after baseline
Patient and Support Person anxiety symptoms
Time frame: 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 32653029Osilla 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Osilla, PhD principal investigator
Stanford University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRAFT in people with Opioid Addiction, run by Stanford University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient buprenorphine retention (time frame: 6 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.