START Program for Opioid Addiction

(START Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist people with opioid addiction (a strong urge to use opioids despite harmful effects) during their hospital stay. It compares the usual care with a special care team, the Substance Use Treatment and Recovery Team (START), which includes an addiction expert and a care manager. This team focuses on initiating medication for opioid use disorder (MOUD) and planning follow-up care after hospital discharge. People diagnosed with opioid use disorder and hospitalized at one of three specific sites are suitable for this trial. Participants must be willing to join follow-up calls and interviews. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for opioid addiction.

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 prior data suggests that the START program is safe for patients with opioid use disorder?

Research shows that the Substance Use Treatment and Recovery Team (START) has participated in past studies to assist people with opioid use disorder (OUD). In one study with 38 patients, nearly all met with the addiction medicine specialist and care manager, and 89% received most of the planned treatment steps.

These studies indicate that the treatment is well-organized and that patients generally adhere to it. However, the available information does not mention specific details about side effects or safety issues. Since this trial is not in an early phase, the treatment is considered safe enough for testing on more people. Prospective participants can find reassurance in knowing that the treatment has already undergone some safety testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the START Program for opioid addiction because it takes a collaborative care approach that is different from usual care methods. Unlike typical treatments that often involve isolated interventions, the START team integrates a comprehensive support system for inpatients. This means patients receive coordinated care from various specialists, all working together to address the complexities of opioid use disorder. This team-based strategy aims to improve patient outcomes by offering more personalized and continuous support, which is a promising shift from conventional approaches.

What evidence suggests that the START program is effective for opioid addiction?

Research has shown that the Substance Use Treatment and Recovery Team (START), which participants in this trial may work with, can treat opioid use disorder (OUD) more effectively. START is a hospital team that helps patients obtain the right medication for OUD. Studies indicate that this team can lower the risk of overdose and increase the use of effective treatments. Patients who work with START are more likely to begin medication for OUD in the hospital and continue their treatment after discharge. This approach connects hospital care with ongoing recovery support. ^{1 6 7 8 9}

Who Is on the Research Team?

Allison J Ober, PhD

Principal Investigator

RAND

Itai Danovitch, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Able to provide informed consent

Exclusion Criteria

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

< 6 months life expectancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

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Opioid Use Disorder: Evaluation and Management - NCBI - NIH

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cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates

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Psychiatry.org - Opioid Use Disorder

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START, a hospital-based addiction consultation service, can improve receipt of evidence-based treatment for people with OUD, potentially reducing overdose and ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2949875923001133

Pilot randomized controlled trial of a hospital-based ...

Of 38 START patients, 97 % met with the addiction medicine specialist and care manager; 89 % received ≥8 of 10 intervention components. All patients receiving ...

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pubmed.ncbi.nlm.nih.gov

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Study Details | NCT05086796 | Substance Use Treatment ...

The START study is a multi-site, randomized trial that will evaluate the intervention improves MOUD initiation and linkage to follow-up care among hospitalized ...