Comprehensive Support Program for Opioid Addiction

(YHEROES Trial)

Overseen By James R Langabeer, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Opioid use disorder medications

Must not be taking: Alcohol, Benzodiazepines

Disqualifiers: Non-English, Alcohol dependence, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist young people in Houston struggling with opioid addiction. It tests a combination of medications, such as buprenorphine and naloxone, alongside counseling and peer support, to evaluate their effectiveness in keeping participants engaged in treatment. The goal is to identify the best ways to support youths in overcoming opioid use disorder. Suitable candidates for this trial include individuals who have tested positive for opioids, wish to quit using them, and are otherwise in good health. Participants must speak English and agree to the study's terms. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are dependent on alcohol, benzodiazepines, or other drugs that need immediate medical attention, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that using buprenorphine and naloxone together is effective and safe for treating opioid addiction. In one study, 538 people with opioid dependence used this combination, and its safety was well-documented. This treatment helps reduce cravings and withdrawal symptoms.

Buprenorphine, a type of medication, can cause mild feelings of euphoria or relaxation at low to moderate doses. Naloxone is included to prevent misuse. Together, they manage addiction without causing a high when taken as prescribed.

The FDA has already approved this combination for treating opioid addiction in adults, indicating a strong safety record. While some side effects like nausea or headaches might occur, they are generally mild. Overall, this treatment is considered well-tolerated and has a strong track record of safety for those with opioid addiction. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the buprenorphine and naloxone drug combination for opioid addiction because it combines medication with behavioral interventions, offering a comprehensive approach to treatment. While traditional options like methadone or standalone buprenorphine focus mainly on reducing withdrawal symptoms and cravings, this combination also emphasizes behavior change, which can enhance recovery outcomes. Additionally, the inclusion of naloxone helps prevent misuse by blocking opioid effects, promoting safer use of the medication.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that combining buprenorphine and naloxone effectively treats opioid use disorder (OUD). Studies have found that this combination significantly lowers the risk of death and aids more patients in achieving recovery. Specifically, one study discovered that continuing buprenorphine treatment can reduce the chance of an opioid overdose by 36%. Medications like buprenorphine greatly decrease both overdose-related deaths and overall mortality. Overall, buprenorphine-naloxone is a proven treatment option for reducing the dangers associated with opioid addiction. Participants in this trial will receive a comprehensive support program, including MOUD induction with buprenorphine-naloxone and behavioral interventions. ^{6 7 8 9 10}

Who Is on the Research Team?

James R Langabeer, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for youths and adolescents in Houston who have tested positive for opioid use, are in good health overall, can speak English, consent to the study (with guardian consent if a minor), want to stop using opioids, and meet criteria for opioid dependence. It's not open to non-English speakers or those with certain medical conditions like unstable heart disease or severe mental health risks.

Inclusion Criteria

I am willing and able to sign the informed consent form.

You have been diagnosed with opioid addiction according to the DSM-IV-TR.

Drug screen positive for opioids

Exclusion Criteria

You are allergic to buprenorphine or naloxone.

I do not have any health conditions that would make joining the study unsafe.

I am not severely depressed, acutely psychotic, or at immediate risk of suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive same-day induction into medication for opioid use disorder (MOUD) and behavioral interventions

30 days

Ongoing visits as needed for MOUD induction and behavioral counseling

Follow-up

Participants are monitored for engagement and retention in treatment, as well as quality of life and relapse prevention

3 years

Routine follow-up visits with peer recovery support and paramedic follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Assertive Outreach
• Buprenorphine, Naloxone Drug Combination
• Individual Counseling
• Peer Recovery Support Services
• Referral to Medication Management
• Support Group

Trial Overview The Young HEROES program tests an integrated approach combining assertive outreach, medication-assisted treatment (like Buprenorphine/Naloxone), counseling, and peer support. The goal is to see how well participants engage with and stick to treatments that help them overcome opioid addiction.

How Is the Trial Designed?

Group I: MOUD induction and behavioral interventions among opioid-dependent youths Experimental Treatment 6 Interventions

Induction into medication for opioid use disorder (MOUD) treatment and behavioral interventions

Buprenorphine, Naloxone Drug Combination is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Suboxone for:

• Opioid use disorder

Approved in European Union as Suboxone for:

• Opioid dependence

Approved in Canada as Suboxone for:

• Opioid use disorder

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Increasing access to buprenorphine, a treatment for opioid use disorder, is crucial for reducing overdose deaths, but limited availability of buprenorphine monoproduct is a significant barrier.

The requirement to prescribe buprenorphine as a combination product with naloxone may lead to adverse effects that are more serious than previously thought, potentially harming the patient-provider relationship and increasing stigma, which can hinder access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Naloxone Component of Buprenorphine/Naloxone: Discouraging Misuse, but at What Cost? Gregg, J., Hartley, J., Lawrence, D., et al.[2023]

The study will involve 280 adults with opioid use disorder and aims to improve adherence to buprenorphine-naloxone treatment through two psychological interventions: contingency management (CM) and brief motivational interviewing plus substance-free activities and mindfulness (BSM).

The primary goal is to assess which intervention is more effective in promoting medication adherence, measured by attendance at physician appointments and the presence of buprenorphine in urine toxicology, with follow-up occurring 8 months after randomization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. Peter, SC., Murphy, JG., Witkiewitz, K., et al.[2023]

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 12-month study involving 384 opioid-dependent patients in Germany showed that buprenorphine-naloxone is highly effective and safe, with low rates of serious adverse events (1.2%) and no reported deaths.

The treatment led to significant improvements in mental health and quality of life, with a 57.1% retention rate, and 96.7% of patients who remained in treatment continued with buprenorphine-naloxone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care. Apelt, SM., Scherbaum, N., Gölz, J., 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]

Only 26.6% of pregnant and parenting patients receiving buprenorphine-naloxone (BUP-NAL) for opioid use disorder reported safe medication storage practices at the start of the study, highlighting a significant safety concern.

After providing a lockbox for medication storage, 93.6% of participants used it, and 89.3% reported safe storage practices at follow-up, demonstrating that lockboxes are a feasible and effective intervention to improve medication safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm Reduction Approach to Increasing Self-reported Safe Medication Storage Among Pregnant and Parenting People Receiving Opioid Use Disorder Treatment. Grist, E., Thakkar, B., Dacha, P., et al.[2023]

After switching from sublingual buprenorphine-naloxone (SLBN) to buccal buprenorphine-naloxone (BBN), there was a significant decrease in overall buprenorphine-naloxone prescriptions by 68%, leading to approximately $3.5 million in quarterly savings for the Medicaid plan.

Toxicology results indicated a notable reduction in drug positivity for opioids and cocaine, suggesting improved adherence to treatment protocols and potentially less misuse or diversion of the medication following the switch to BBN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decline in Buprenorphine/Naloxone Prescriptions in a State Medicaid Population Following Formulary Conversion from Suboxone to Bunavail. Soper, R., Appajosyula, S., Deximo, C.[2019]

Patients on buprenorphine maintenance therapy showed significantly better engagement in intensive outpatient programs (IOP), remaining in treatment for an average of 8.5 weeks compared to just 0.4 weeks for those who underwent detoxification with tramadol.

The study suggests that buprenorphine maintenance not only alleviates withdrawal symptoms effectively but also enhances retention in comprehensive outpatient addiction treatment, indicating its potential as a more effective approach than traditional detoxification methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient initiation of buprenorphine maintenance vs. detoxification: can retention of opioid-dependent patients in outpatient counseling be improved? Caldiero, RM., Parran, TV., Adelman, CL., et al.[2016]

Buprenorphine-naloxone (bup/nal) is FDA-approved for addiction treatment and shows potential for pain relief in patients with chronic pain who also have opioid dependence, but it is a weak analgesic for those without addiction.

The pain relief mechanisms of bup/nal may involve reversing opioid-induced hyperalgesia and improving opioid tolerance, indicating a need for further research on its use in pain management and anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone therapy in pain management. Chen, KY., Chen, L., Mao, J.[2021]

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]

The Massachusetts initiative successfully expanded the Office-Based Opioid Treatment with buprenorphine (OBOT-B) model to 14 community health centers, increasing the number of physicians authorized to prescribe buprenorphine by 375% over three years.

This collaborative care model, which emphasizes the role of nurses alongside physicians, effectively improved access to treatment for opioid use disorders, leading to a significant rise in patient admissions to these health centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers. LaBelle, CT., Han, SC., Bergeron, A., et al.[2018]

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]

The novel weekly subcutaneous buprenorphine depot formulation, CAM2038, was found to effectively block the euphoric effects of opioids and suppress withdrawal symptoms in individuals with moderate-to-severe opioid use disorder, based on a study involving 47 participants.

Both doses of CAM2038 (24 mg and 32 mg) were well-tolerated and demonstrated significant efficacy in preventing opioid effects, making it a promising alternative to daily oral formulations that carry risks of misuse and nonadherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals With Opioid Use Disorder: A Randomized Clinical Trial. Walsh, SL., Comer, SD., Lofwall, MR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11610725/

Buprenorphine-Naloxone for Opioid Use Disorder Buprenorphine-naloxone was associated with significantly reduced mortality and increased remission rates for patients with opioid use disorder.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2825088

Buprenorphine/Naloxone vs Methadone for the Treatment ... The risk of treatment discontinuation was higher among recipients of buprenorphine/naloxone compared with methadone (88.8% vs 81.5% within 24 months).

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

Treatment for Opioid Use Disorder: Population Estimates Medications for opioid use disorder (OUD), particularly buprenorphine and methadone, substantially reduce overdose-related and overall mortality ...

4. mdpi.com mdpi.com/2813-0618/1/3/10

Evaluation of the Effectiveness of Buprenorphine-Naloxone ... Their results demonstrated that an additional 100-day buprenorphine treatment was associated with a 36% reduction in risk of opioid overdose ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871622003416

Buprenorphine/naloxone and methadone effectiveness for ... Compared to the standard methadone model of care, flexible take-home dosing of BUP/NX was associated with lower craving in individuals with POUD.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/204242s031lbl.pdf

Reference ID: 5593165 - accessdata.fda.gov In total, safety data were available for 538 opioid-dependent subjects exposed to ZUBSOLV. (buprenorphine/naloxone) sublingual tablets when used for initial ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603725/

Buprenorphine and Naloxone - StatPearls - NCBI Bookshelf Buprenorphine-naloxone is an effective and commonly prescribed combination medication created to treat opioid use disorder. Mechanism.

8. samhsa.gov samhsa.gov/substance-use/treatment/options/buprenorphine

What is Buprenorphine? Side Effects, Treatment & Use Buprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. With ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/buprenorphine-naloxone-oromucosal-route-sublingual-route/description/drg-20074097

Buprenorphine/naloxone (oromucosal route, sublingual ... Buprenorphine and naloxone sublingual tablet is used to treat opioid (narcotic) dependence or addiction.

10. health.ny.gov health.ny.gov/publications/0111.pdf

Buprenorphine for Opioid Use Disorder Medications To Treat. Opioid Use Disorder. 35. FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients ...