Support Person Involvement for Opioid Addiction

(INSPIRE Trial)

Recruiting at 5 trial locations

Overseen By Katherine Nameth

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: Buprenorphine

Disqualifiers: Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 6 months

422 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must already be on buprenorphine treatment for opioid use disorder to participate.

What data supports the effectiveness of the drug Suboxone for opioid addiction?

Research shows that buprenorphine, a key component of Suboxone, is effective in treating opioid dependence by reducing harms associated with opioid use disorder and improving patient retention in treatment. ^{1 2 3 4 5}

Is buprenorphine/naloxone safe for treating opioid addiction?

Research shows that buprenorphine/naloxone is generally safe for treating opioid addiction. Studies have demonstrated its safety in reducing withdrawal symptoms and cravings, and it has been used effectively in various treatment settings. ^{1 6 7 8 9}

How is the drug CRAFT (Suboxone, Zubsolv, Bunavail, Cassipa) unique for treating opioid addiction?

CRAFT involves the use of buprenorphine, a partial opioid agonist, which can be prescribed in an office-based setting, making it more accessible than traditional treatments like methadone. It combines buprenorphine with naloxone to reduce misuse potential, and it is effective in both maintenance and detoxification, offering flexibility in treatment. ^{1 10 11 12 13}

Research Team

Karen Osilla, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 with Opioid Use Disorder (OUD) who are currently on buprenorphine treatment. They must be willing to try the CRAFT counseling program and have frequent contact with a support person, such as family or friend, who will participate in the study.

Inclusion Criteria

I am currently on buprenorphine for opioid use disorder.

You have regular contact with the patient.

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Buprenorphine/Naloxone treatment and support persons may receive CRAFT intervention

6 months

10 sessions for support persons (CRAFT group)

Follow-up

Participants and support persons are monitored for health outcomes and treatment retention

12 months

Interviews at 3 and 12 months

Treatment Details

Interventions

• CRAFT

Trial Overview The INSPIRE project is testing if involving a patient's support person in their recovery process can improve outcomes. It focuses on whether the CRAFT counseling program for supporters enhances the effectiveness of Buprenorphine/Naloxone treatment for OUD.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.

Group II: Control Active Control 1 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.

CRAFT is already approved in United States, European Union for the following indications:

Approved in United States as Suboxone for:

• Opioid use disorder

Approved in European Union as Suboxone for:

• Opioid dependence

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

Buprenorphine and buprenorphine/naloxone have been approved for office-based treatment of opioid dependence, and a consensus among experts emphasizes the need for comprehensive training and support for healthcare providers to effectively use these medications.

Key recommendations include the importance of concurrent counseling, proper patient induction protocols, and the necessity of follow-up treatment to prevent relapse, highlighting the multifaceted approach required for successful opioid dependence management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus statement on office-based treatment of opioid dependence using buprenorphine. Fiellin, DA., Kleber, H., Trumble-Hejduk, JG., et al.[2013]

In a study involving 300 opioid-dependent African American participants, both outpatient (OP) and intensive outpatient (IOP) counseling levels provided alongside buprenorphine treatment led to significant improvements in various measures of substance use and quality of life over 6 months.

There were no significant differences in treatment outcomes between the OP and IOP groups, indicating that both levels of counseling are effective for patients receiving buprenorphine, regardless of the intensity of counseling provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans. Mitchell, SG., Gryczynski, J., Schwartz, RP., et al.[2022]

A community-based opioid-dependence treatment program in a remote First Nations community, combining traditional healing strategies with buprenorphine-naloxone substitution therapy, led to significant improvements in community wellness, including a 61.1% reduction in police criminal charges and a 58.3% decrease in child protection cases after one year.

The program also resulted in increased school attendance by 33.3% and a remarkable 350.0% rise in seasonal influenza immunizations, highlighting the positive impact of integrating culturally relevant treatment approaches in addressing opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-wide measures of wellness in a remote First Nations community experiencing opioid dependence: evaluating outpatient buprenorphine-naloxone substitution therapy in the context of a First Nations healing program. Kanate, D., Folk, D., Cirone, S., et al.[2022]

In a study of 255,726 Veterans with opioid use disorder (OUD), 15.8% received buprenorphine medication treatment (B-MOUD), with a significant increase in treatment courses over time, from 1550 in 2007 to 8146 in 2018.

Patients receiving B-MOUD had a median treatment duration of 157 days, with 33.8% undergoing multiple treatment courses, indicating that B-MOUD is a commonly utilized and persistent treatment option for managing OUD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. Gordon, AJ., Saxon, AJ., Kertesz, S., et al.[2023]

Buprenorphine implants were found to be noninferior to daily sublingual buprenorphine in maintaining opioid abstinence over a 6-month period, with 85.7% of implant users remaining abstinent compared to 71.9% of those on sublingual treatment.

The study involved 177 participants and showed that both treatment methods had similar response rates, but the implant group experienced fewer non-implant-related adverse events, suggesting a potentially safer option for long-term maintenance treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. Rosenthal, RN., Lofwall, MR., Kim, S., et al.[2016]

In a study of 313 opioid-dependent adults, the sublingual buprenorphine/naloxone rapidly dissolving tablet was found to be less effective than generic buprenorphine for treatment retention at day 3, with 88.3% retention compared to 95.3% for generic buprenorphine.

Despite the lower retention rate, both treatments showed similar effectiveness in reducing withdrawal symptoms and cravings, indicating that buprenorphine/naloxone is generally safe and can still help manage withdrawal despite not being non-inferior to generic buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a sublingual buprenorphine/naloxone rapidly dissolving tablet for the treatment of adults with opioid dependence: A randomized trial. Webster, L., Hjelmström, P., Sumner, M., et al.[2017]

In a study of 78 patients over six years at the High-Risk Pain Clinic, buprenorphine/naloxone was found to significantly reduce pain scores, indicating its efficacy in managing chronic pain for patients with a history of substance use disorder.

The clinic had a retention rate of 41%, suggesting that while many patients continued treatment, there is still a notable number who may not stay engaged in this multimodal approach to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. Kaski, S., Marshalek, P., Herschler, J., et al.[2021]

A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved for treating opioid dependency, offering advantages like rapid dissolution and better taste compared to traditional tablets.

In a study with 34 opioid-dependent volunteers, both buprenorphine and buprenorphine/naloxone films significantly reduced withdrawal symptoms, indicating that both formulations are safe and effective for opioid induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. Strain, EC., Harrison, JA., Bigelow, GE.[2022]

The Buprenorphine Pilot Program in San Francisco successfully treated 57 opioid-dependent patients, achieving a one-year retention rate of 61% and a significant reduction in opioid use, highlighting the efficacy of buprenorphine in a challenging patient population.

Patients reported very positive impressions of the program and buprenorphine, while providers showed significant changes in their practices over time, indicating increased acceptance and support for buprenorphine treatment in public health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating buprenorphine treatment into a public healthcare system: the San Francisco Department of Public Health's office-based Buprenorphine Pilot Program. Hersh, D., Little, SL., Gleghorn, A.[2022]

Prescription opioid abuse is now more prevalent than heroin abuse in the U.S., with about 1.6 million people affected, yet 80% of those with opioid dependence remain untreated.

Buprenorphine, a partial opioid agonist, offers a promising treatment option for opioid dependence and can be prescribed in office settings, allowing for greater accessibility and potentially improving treatment rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrative review: buprenorphine for opioid-dependent patients in office practice. Sullivan, LE., Fiellin, DA.[2021]

Patients receiving buprenorphine treatment for opioid addiction found it effective in achieving their treatment goals, appreciating the flexibility, accessibility, and privacy it offered.

Strong physician-patient relationships and team-based care models were highly valued by patients, suggesting that buprenorphine-prescribing physicians can enhance treatment by fostering a supportive environment and maintaining open communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing psychosocial support during office-based buprenorphine treatment in primary care: Patients' experiences and preferences. Fox, AD., Masyukova, M., Cunningham, CO.[2018]

Buprenorphine is an effective alternative to methadone for managing opioid dependence, providing a viable option for patients who may benefit from different treatment approaches.

The review highlights the increasing need for opioid substitution treatments in England and Wales, where around 250,000 individuals struggle with serious drug problems, emphasizing the importance of effective management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine for opioid dependence. [2019]

Buprenorphine, a partial mu-opioid receptor agonist, is an effective and well-tolerated treatment for opioid dependence, comparable to methadone, and can now be prescribed by all physicians in office-based settings due to the Drug Addiction Treatment Act of 2000.

It is available in two formulations: Subutex (buprenorphine only) and Suboxone (buprenorphine with naloxone), but physicians must obtain a special waiver to prescribe it and are limited to 30 patients at a time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine: a (relatively) new treatment for opioid dependence. Welsh, C., Valadez-Meltzer, A.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Consensus statement on office-based treatment of opioid dependence using buprenorphine. [2013]

2. Ireland pubmed.ncbi.nlm.nih.gov

A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Community-wide measures of wellness in a remote First Nations community experiencing opioid dependence: evaluating outpatient buprenorphine-naloxone substitution therapy in the context of a First Nations healing program. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a sublingual buprenorphine/naloxone rapidly dissolving tablet for the treatment of adults with opioid dependence: A randomized trial. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Integrating buprenorphine treatment into a public healthcare system: the San Francisco Department of Public Health's office-based Buprenorphine Pilot Program. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Narrative review: buprenorphine for opioid-dependent patients in office practice. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Optimizing psychosocial support during office-based buprenorphine treatment in primary care: Patients' experiences and preferences. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Buprenorphine for opioid dependence. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Buprenorphine: a (relatively) new treatment for opioid dependence. [2021]