Support Person Involvement for Opioid Addiction
(INSPIRE Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must be taking: Buprenorphine
Disqualifiers: Substance use, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
26789How 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.
210111213Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Community Reinforcement Approach and Family Training is a 10-session rolling group for the support person.
Group II: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Open Door Community Health CentersArcata, CA
Lifelong Medical CareBerkeley, CA
Behavioral Health ServicesGardena, CA
Family Health Centers of San DiegoSan Diego, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans. [2022]Buprenorphine is increasingly being used in community-based treatment programs, but little is known about the optimal level of psychosocial counseling in these settings. The aim of this study was to compare the effectiveness of OP and IOP level counseling when provided as part of buprenorphine treatment for opioid-dependent African Americans.
Consensus statement on office-based treatment of opioid dependence using buprenorphine. [2013]Buprenorphine and buprenorphine/naloxone (BUP) are newly approved for office-based treatment of opioid dependence. Federal and non-federal regulatory and monitoring agencies, national and international researchers, national professional organizations, researchers involved in monitoring, opioid treatment programs and the pharmaceutical industry met to synthesize and disseminate practical information to guide training, practice, monitoring, regulation and evaluation efforts with these medications. We performed a review of the literature, training curricula and practice guidelines and commissioned manuscripts describing recently completed, or still in progress, studies or field experiences with BUP treatment. A consensus process generated fifteen statements: (1) The federal government should collect baseline data on opioid-related deaths and morbidity to assess the effect of BUP on public health, (2) the patient limit for group practices should apply to individual physicians rather than group practices, (3 and 4) telephone and Internet-based physician and pharmacist support is needed, (5) clinicians who provide psychosocial services to opioid dependent patients should be informed of the role of BUP, (6) opioid-dependent patients should be instructed to present for induction in mild withdrawal, (7) the existing Center for Substance Abuse Treatment guidelines provide a reasonable induction protocol, (8) physicians should be prepared to use ancillary medications with BUP induction, (9) a physician or nurse must be available to the patient during the induction period, (10) concurrent counseling and support services are necessary, (11) detoxification without appropriate followup addiction treatment leads to rapid relapse and is not as effective as maintenance, (12) pregnant opioid-dependent women should be treated using good clinical practice including specialist addiction care and prenatal care, (13) BUP induction and withdrawal treatment may benefit from different designations for payment, (14) take-home medication options should be tailored to patients' needs, (15) there is a need for clinical and policy research in unique patient populations.
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]To document the development of unique opioid-dependence treatment in remote communities that combines First Nations healing strategies and substitution therapy with buprenorphine-naloxone.
Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. [2023]Retention of patients in buprenorphine medication treatment for opioid use disorder (B-MOUD) reduces harms associated with opioid use disorder (OUD). We sought to characterize the patients receiving B-MOUD and courses of B-MOUD in a large healthcare system.
Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial. [2016]The effectiveness of buprenorphine treatment of opioid dependence is limited by suboptimal medication adherence, abuse, and diversion.
Sublingual Buprenorphine/Naloxone and Multi-Modal Management for High-Risk Chronic Pain Patients. [2021]Patients with chronic pain managed with opioid medications are at high risk for opioid overuse or misuse. West Virginia University (WVU) established a High-Risk Pain Clinic to use sublingual buprenorphine/naloxone (bup/nal) plus a multimodal approach to help chronic pain patients with history of Substance Use Disorder (SUD) or aberrant drug-related behavior. The objective of this study was to report overall retention rates and indicators of efficacy in pain control from approximately six years of High-Risk Pain Clinic data. A retrospective chart review was conducted for a total of 78 patients who enrolled in the High-Risk Pain Clinic between 2014 and 2020. Data gathered include psychiatric diagnoses, prescribed medications, pain score, buprenorphine/naloxone dosing, time in clinic, and reason for dismissal. A linear mixed effects model was used to assess the pain score from the Defense and Veterans Pain Rating Scale (DVPRS) and daily bup/nal dose across time. The overall retention of the High-Risk Pain Clinic was 41%. The mean pain score demonstrated a significant downward trend across treatment time (p < 0.001), while the opposite trend was seen with buprenorphine dose (p < 0.001). With the benefit of six years of observation, this study supports buprenorphine/naloxone as a safe and efficacious component of comprehensive chronic pain treatment in patients with SUD or high-risk of opioid overuse or misuse.
Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. [2022]A sublingual soluble-film formulation of buprenorphine/naloxone (B/N) has been approved by the US Food and Drug Administration for the treatment of opioid dependency. This preparation provides unit-dose, child-resistant packaging amenable to tracking and accountability, offers more rapid dissolution, and has a potentially preferred taste vs. tablets. This study compared the ability of buprenorphine (B) and B/N films to suppress spontaneous withdrawal in opioid-dependent volunteers. Participants were maintained on morphine and underwent challenge sessions to confirm sensitivity to naloxone-induced opioid withdrawal. Subjects were randomized to receive either B (16 mg, n = 18) or B/N (16/4 mg, n = 16) soluble films for 5 days. The primary outcome measure was the Clinical Opiate Withdrawal Scale (COWS) score. Thirty-four subjects completed induction onto soluble films. There was a significant decrease in COWS scores but no significant differences between the groups. The results support the use of B and B/N soluble films as safe and effective delivery methods for opioid induction.
Integrating buprenorphine treatment into a public healthcare system: the San Francisco Department of Public Health's office-based Buprenorphine Pilot Program. [2022]Despite well-documented efficacy, US physicians have been relatively slow to embrace the use of buprenorphine for the treatment of opioid dependence. In order to introduce and support the use of buprenorphine across the San Francisco Department of Public Health system of care, the Buprenorphine Pilot Program was initiated in 2003. Program treatment sites included a centralized buprenorphine induction clinic and program pharmacy, and three community-based treatment sites; two primary care clinics and a private dual diagnosis group practice. The target patient population consisted of opioid-dependent patients typically seen in an urban, public health setting, including individuals experiencing extreme poverty, homelessness/unstable housing, unemployment, polysubstance abuse/dependence, coexisting mental health disorders, and/or little psychosocial support. This program evaluation reviews patient characteristics, treatment retention, substance use over time, patient impressions, and provider practices for the 57 patients admitted between 9/1/03 and 8/31/05. At baseline, over 80% of patients were injecting heroin, over 40% were homeless, and over one-third were using cocaine. Outcomes included an overall one-year retention rate of 61%, a rapid and dramatic decline in opioid use, very positive patient impressions of the program and of buprenorphine, and significant shifts in provider practices over time.
Efficacy and safety of a sublingual buprenorphine/naloxone rapidly dissolving tablet for the treatment of adults with opioid dependence: A randomized trial. [2017]This prospective, randomized, active-controlled, non-inferiority study evaluated the efficacy and safety of a sublingual buprenorphine/naloxone rapidly dissolving tablet (Zubsolv®; buprenorphine/naloxone rapidly dissolving tablet) versus generic buprenorphine for induction of opioid maintenance among dependent adults. The study, conducted at 13 sites from June 2013 to January 2014, included a 2-day blinded induction phase and a 27-day open-label stabilization/maintenance phase. During the blinded induction, patients received fixed doses of buprenorphine/naloxone rapidly dissolving tablets or generic buprenorphine. During open-label stabilization/early maintenance, all patients received buprenorphine/naloxone rapidly dissolving tablets. The primary efficacy assessment was treatment retention at day 3; buprenorphine/naloxone rapidly dissolving tablets were considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between the treatments was ≥-10% in patients retained on day 3. Secondary assessments included opioid withdrawal symptoms and cravings as measured using the Clinical Opiate Withdrawal Scale, the Subjective Opiate Withdrawal Scale, and the opioid cravings visual analogue scale. Safety was also assessed. A total of 313 patients were randomly assigned to induction with generic buprenorphine or buprenorphine/naloxone rapidly dissolving tablets. The mean age was 38.4 years, and the mean duration of opioid dependence was 12.4 years. For the primary efficacy assessment, 235 of 256 patients (91.8%) were retained at day 3 and continued to the maintenance phase. The lower limit of the 95% confidence interval was -13.7; thus, buprenorphine/naloxone rapidly dissolving tablets did not demonstrate non-inferiority to generic buprenorphine, and significantly more patients who received induction with generic buprenorphine (122/128 [95.3%]) were retained at day 3 compared with those who received induction with buprenorphine/naloxone rapidly dissolving tablets (113/128 [88.3%]; 95% confidence interval: -13.7, -0.4; p = 0.040). The rates of clinical response, as measured by the Clinical Opiate Withdrawal Scale, the Subjective Opiate Withdrawal Scale, and the visual analogue scale, were comparable among patients regardless of the induction medication. Treatment with buprenorphine/naloxone rapidly dissolving tablets was generally safe and reduced the severity of withdrawal symptoms and cravings.
Narrative review: buprenorphine for opioid-dependent patients in office practice. [2021]The profile of opioid dependence in the United States is changing. Abuse of prescription opioids is more common than that of illicit opioids: Recent data indicate that approximately 1.6 million persons abuse or are dependent on prescription opioids, whereas 323,000 abuse or are dependent on heroin. Despite this prevalence, nearly 80% of opioid-dependent persons remain untreated. One option for expanding treatment is the use of buprenorphine and the buprenorphine-naloxone combination. Buprenorphine is a partial opioid agonist that can be prescribed by trained physicians and dispensed at pharmacies. This article addresses the clinical presentation of a patient with opioid dependence and describes the relatively new practice of office-based treatment with buprenorphine-naloxone. The different components of treatment; the role of the physician who provides this treatment; and the logistics of treating this growing, multifaceted patient population are also examined.
Optimizing psychosocial support during office-based buprenorphine treatment in primary care: Patients' experiences and preferences. [2018]Buprenorphine maintenance treatment is effective and has been successfully integrated into human immunodeficiency virus (HIV) and primary care settings. However, one key barrier to providers prescribing buprenorphine is their perception that they are unable to provide adequate counseling or psychosocial support to patients with opioid addiction. This qualitative study investigated supportive elements of office-based buprenorphine treatment that patients perceived to be most valuable.
Buprenorphine for opioid dependence. [2019]In England and Wales, estimates suggest around 250,000 people have serious drug problems such as dependency, that cause considerable harm to themselves and others, and give rise to high social and economic costs. The number of people receiving specialist treatment for drug problems has increased greatly in recent years. Many people dependent on opioids will require opioid substitution treatment at some time. This may involve long-term maintenance to reduce use of illicit drugs, and/or short-term detoxification to stop such use completely. Standard management involves methadone maintenance therapy. Buprenorphine (Subutex-Schering-Plough) is also licensed for the management of patients with opioid dependence. Here we review the evidence for the use of buprenorphine compared with methadone for opioid dependence.
Buprenorphine: a (relatively) new treatment for opioid dependence. [2021]Opioid dependence is a significant and growing problem in the United States. For nearly a century, federal regulations have made it illegal for psychiatrists and other physicians to pharmacologically manage this condition in an office-based setting using opioids. The passage of the Drug Addiction Treatment Act of 2000 has made it possible for all physicians to prescribe buprenorphine to patients in such a setting. Buprenorphine, a partial mu-opoid receptor agonist, has unique pharmacologic properties that distinguish it from methadone and other medications used in the treatment of opioid dependence. It has been shown to be as effective as methadone and is generally safe and well-tolerated. It is available in two sublingual formulations: Subutex, which contains only buprenorphine, and Suboxone, which also contains naloxone. Physicians who wish to prescribe either must obtain a special waiver from the federal government and are currently limited to prescribing it for 30 patients at a time.