325 Participants Needed

START Program for Opioid Addiction

(START Trial)

Recruiting at 2 trial locations
MM
Overseen ByMia Mazer
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.36789

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.910111213

Research Team

ID

Itai Danovitch, MD

Principal Investigator

Cedars-Sinai Medical Center

AJ

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.
See 3 more

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 OverviewThe 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
2Treatment groups
Active Control
Group I: Substance Use Treatment and Recovery Team (START)Active Control1 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 CareActive Control1 Intervention
Usual care for people with opioid use disorder.

Find a Clinic Near You

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.
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.
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.
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]

References

Noninferiority Clinical Trial of Adapted START NOW Psychotherapy for Outpatient Opioid Treatment. [2023]
Long-term recovery from opioid use disorder: recovery subgroups, transition states and their association with substance use, treatment and quality of life. [2023]
Improved Patient Outcomes and Reduced Wait Times: Transforming a VA Outpatient Substance Use Disorder Program. [2023]
Buprenorphine from detox and beyond: preliminary evaluation of a pilot program to increase heroin dependent individuals' engagement in a full continuum of care. [2015]
Naltrexone plus group therapy for the treatment of opiate-abusing health-care professionals. [2019]
A Plea From People Who Use Drugs to Clinicians: New Ways to Initiate Buprenorphine Are Urgently Needed in the Fentanyl Era. [2023]
COVID-19: A new barrier to treatment for opioid use disorder in the emergency department. [2022]
The New Kid on the Block--Incorporating Buprenorphine into a Medical Toxicology Practice. [2018]
Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. [2022]
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 Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
The multi-site prescription opioid addiction treatment study: 18-month outcomes. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Long-term course of opioid addiction. [2015]