START Program for Opioid Addiction

(START Trial)

Recruiting at 2 trial locations

Overseen By Mia Mazer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Opioid treatment medications

Disqualifiers: Less than 6 months life expectancy

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

Compensation: Varies

Number of Visits: 1

325 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a special hospital team (START) can help patients with opioid addiction by starting treatment in the hospital and planning for their care after they leave. The goal is to see if this approach improves treatment and reduces future health risks. The START intervention aims to improve care for hospitalized patients with opioid use disorder by initiating medication and linking them to post-discharge treatment.

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 cannot participate if you are already receiving FDA-approved medication for opioid use disorder.

What data supports the effectiveness of the START treatment for opioid addiction?

The START NOW psychotherapy, part of the START treatment, has been shown to reduce disciplinary issues and psychiatric hospital stays in other settings, suggesting it may help with opioid addiction as well. Additionally, a redesigned substance use disorder program improved patient outcomes and reduced wait times, indicating that systematic approaches like START can be effective. ^{1 2 3 4 5}

Is the START Program for Opioid Addiction safe for humans?

Research shows that buprenorphine-naloxone, used in the START Program, is generally safe for treating opioid dependence. In clinical trials, it was well tolerated with a good safety profile, and only one serious adverse event was possibly related to the medication. ^{3 6 7 8 9}

How is the START Program for Opioid Addiction different from other treatments?

The START Program for Opioid Addiction is unique because it integrates community-based treatment with buprenorphine-naloxone, a medication that can be used outside traditional opioid treatment programs, making it more accessible and practical for diverse settings. This approach combines medication with community support, which can enhance treatment engagement and success. ^{9 10 11 12 13}

Research Team

Itai Danovitch, MD

Principal Investigator

Cedars-Sinai Medical Center

Allison J Ober, PhD

Principal Investigator

RAND

Eligibility Criteria

This trial is for adults over 18 who are hospitalized with opioid use disorder (OUD) and not currently on FDA-approved medication for OUD. Participants must speak English or Spanish, be willing to do follow-up calls, and have a life expectancy of more than 6 months.

Inclusion Criteria

I am currently admitted as an inpatient at CSMC, UNM, or BH.

My primary language is either English or Spanish.

I am 18 years old or older.

Exclusion Criteria

I am currently on FDA-approved medication for opioid addiction.

< 6 months life expectancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Inpatient Treatment

Participants receive the START intervention, including MOUD initiation and OUD-focused discharge planning, during their hospital stay

1 week

Inpatient stay

Follow-up

Participants are monitored for linkage to follow-up OUD care and post-discharge MOUD utilization

4 weeks

At least 1 visit (in-person or virtual)

Post-discharge Monitoring

Participants' opioid use and outpatient medical care are tracked for 30 days post-discharge

4 weeks

Treatment Details

Interventions

• Substance Use Treatment and Recovery Team (START)

Trial Overview The START program is being tested at three hospitals. It involves an addiction specialist and care manager helping patients get medication for OUD and planning post-discharge care. Patients will either receive this special team support or usual care.

Participant Groups

Group I: Substance Use Treatment and Recovery Team (START) Active Control 1 Intervention

The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder.

Group II: Usual Care Active Control 1 Intervention

Usual care for people with opioid use disorder.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials

100

Recruited

32,100+

RAND

Collaborator

Trials

145

Recruited

617,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Baystate Health

Collaborator

Trials

9

Recruited

54,500+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Findings from Research

In a study involving 137 participants, the adapted START NOW psychotherapy was found to be as effective as standard treatment-as-usual (TAU) for opioid use disorder, with similar attendance and drug use outcomes over 32 weeks.

START NOW psychotherapy is freely available and could be particularly beneficial in low-resource settings, making it a valuable option for treating opioid use disorder alongside medications like buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. Truong, A., Kablinger, A., Hartman, C., et al.[2023]

The pilot buprenorphine treatment program (BTP) showed significant improvements in treatment engagement for detoxified heroin users, with increased referrals to intensive inpatient programs and higher completion rates of outpatient treatment.

Participants who completed the BTP reported greater challenges in achieving abstinence but were less likely to use cocaine or alcohol and had lower relapse rates, suggesting that buprenorphine may enhance the effectiveness of post-detoxification care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine from detox and beyond: preliminary evaluation of a pilot program to increase heroin dependent individuals' engagement in a full continuum of care. Donovan, DM., Knox, PC., Skytta, JA., et al.[2015]

Conventional methods for starting buprenorphine treatment for opioid use disorder, which require patients to be in withdrawal, are inadequate in the current fentanyl crisis, leading to challenges like precipitated withdrawal.

Involving people who use drugs in the development of new strategies for buprenorphine initiation is crucial, as their experiences can inform more effective and life-saving treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Plea From People Who Use Drugs to Clinicians: New Ways to Initiate Buprenorphine Are Urgently Needed in the Fentanyl Era. Sue, KL., Cohen, S., Tilley, J., et al.[2023]

Buprenorphine-naloxone (Suboxone) was found to be safe and well tolerated for short-term opioid detoxification in a study involving 234 opioid-dependent patients across twelve community-based treatment programs.

The treatment showed high medication compliance (81% of doses ingested) and successful induction, with 90% of patients reaching the target dose within three days, indicating its efficacy and practicality in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Amass, L., Ling, W., Freese, TE., 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]

A novel group prenatal care program for pregnant women with opioid use disorder combines prenatal care, substance use counseling, and medication-assisted treatment, showing improved satisfaction and adherence to care among participants.

Participants in the program reported increased trust in healthcare providers, better prenatal care experiences, and enhanced resilience against relapse, indicating that this model could lead to better outcomes for both mothers and their newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Prenatal Care for Women Receiving Medication-Assisted Treatment for Opioid Use Disorder in Pregnancy: An Interprofessional Approach. Sutter, MB., Watson, H., Bauers, A., et al.[2020]

Opioid addiction is a chronic disorder characterized by high relapse rates, with long-term studies showing that less than 30% of individuals achieve stable abstinence after 10-30 years, and overdose is the leading cause of increased mortality (6 to 20 times higher than the general population).

Factors such as longer treatment retention, family and social support, and stable employment significantly enhance recovery chances, while histories of abuse and comorbid mental disorders hinder progress; recent pharmacological treatments like buprenorphine and naltrexone show promise, but their long-term effects are still being evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term course of opioid addiction. Hser, YI., Evans, E., Grella, C., et al.[2015]

References

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

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Long-term recovery from opioid use disorder: recovery subgroups, transition states and their association with substance use, treatment and quality of life. [2023]

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

Improved Patient Outcomes and Reduced Wait Times: Transforming a VA Outpatient Substance Use Disorder Program. [2023]

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

Buprenorphine from detox and beyond: preliminary evaluation of a pilot program to increase heroin dependent individuals' engagement in a full continuum of care. [2015]

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

Naltrexone plus group therapy for the treatment of opiate-abusing health-care professionals. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Plea From People Who Use Drugs to Clinicians: New Ways to Initiate Buprenorphine Are Urgently Needed in the Fentanyl Era. [2023]

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

COVID-19: A new barrier to treatment for opioid use disorder in the emergency department. [2022]

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

The New Kid on the Block--Incorporating Buprenorphine into a Medical Toxicology Practice. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. [2022]

10. 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]

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

Group Prenatal Care for Women Receiving Medication-Assisted Treatment for Opioid Use Disorder in Pregnancy: An Interprofessional Approach. [2020]

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

The multi-site prescription opioid addiction treatment study: 18-month outcomes. [2021]

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

Long-term course of opioid addiction. [2015]