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Opioid UsePhase 2NCT03744663

Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

A Phase 2 study testing Suboxone® SL and Sublocade® in people with Opioid Use, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Use
What is being tested?
Suboxone® SL and Sublocade®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2022to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who present to the WFBMC Medication-Assisted-Therapy (MAT) clinic seeking OBOT.

Who cannot join

  • Those patients who have:
  • history of cirrhosis, >= CKD stage 3
  • congenital long QT syndrome
  • those on antiarrhythmic medications
  • liver enzymes more than 2 times the upper normal value at baseline assessment
  • elevated bilirubin
Show all 10Show fewer
  • chronic pulmonary condition
  • current unstable and untreated psychiatry comorbid disorder
  • pregnant
  • use of benzodiazepines/other CNS depressant medications

About this study

Official title: A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. This study aims to determine the feasibility of enrolling and randomizing patients seeking treatment at an outpatient substance abuse clinic to buprenorphine/naloxone films which dissolve under the tongue vs. long acting buprenorphine injection with all other treatment aspects held constant. The study also aims to determine the effectiveness of monthly injections of Sublocade® compared to daily oral Suboxone® SL therapy in the treatment of moderate to severe opioid use disorder after twenty-four weeks of treatment.

Read the detailed description

While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. Fortunately, the FDA has recently approved a long acting subcutaneous injectable formulation of buprenorphine. While this drug has proven effective in retaining patients in care and decreasing drug cravings as compared to placebo, this drug has not been tested in a real world clinic setting and no studies exist comparing it to the current formulations of buprenorphine. The objective of this study is to perform a randomized pilot study directly comparing sublingual buprenorphine/naloxone to long acting buprenorphine subdermal injection in a standard Office-Based Opioid Agonist Treatment (OBOT) clinic. The study team will compare patient retention, percentage of negative urinary drug screens, and withdrawal scores between the two groups. The findings will provide insight for US providers seeking more effective and efficient ways to treat Opioid use disorder (OUD) in the outpatient setting.

Conditions
Opioid Use
Being tested
Suboxone® SL, Sublocade®
Keywords
opioid, Opioid Agonist Treatment, buprenorphine, substance abuse, drug, abstinence
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suboxone® SLDrug

    Also called Suboxone® SL films, buprenorphine naloxone

    Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized to two groups one of which will be Suboxone® SL.

  • Sublocade®Drug

    Also called buprenorphine extended-release

    Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized, either Suboxone® SL or Sublocade®. Subjects with significant opioid craving (> 20 mm on the Opioid Craving Visual Analog Scale) or withdrawal (a score of > 12 on the Clinical Opiate Withdrawal Scale) after 14 days of treatment will be started on Sublocade® only at the consensus of the research team. Otherwise they will undergo an additional 7 day titration period. Study drug with Sublocade® group: Patients assigned to this group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. The location and specifications of its application will follow the recommendations by the FDA previously published.

Study groups in NCT03744663
Study groupRoleWhat they receive
Suboxone® SLActive comparatorPatients assigned to this group will continue with their already established dose of Suboxone ® SL films for 24 weeks along with weekly therapy.
Receives: Drug: Suboxone® SL
Sublocade®ExperimentalPatients assigned to the Sublocade® group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy.
Receives: Drug: Sublocade®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Weeks patients continued in treatment during trial period

    Retention in weeks

    Measured: 26 weeks

  2. Number of Participants that Dropout during the first 28 days of Treatment

    Number of participants that leave the study

    Measured: first 28 days

  3. Number of participants that complete of the treatment phase

    Number of participants that complete the study

    Measured: 26 weeks

  4. Number of participants who did not complete the trial in their assigned group

    Total number of participants that changed arms

    Measured: 26 weeks

  5. Percentage of negative urinary drug screens

    percentage of participants that have a negative drug screen

    Measured: 26 weeks

  6. Liver enzyme values - ALP, AST, ALT

    Values of liver enzymes will be measured: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT). Values will be reported in IU/L

    Measured: 26 weeks

  7. Liver enzyme values- Total Bilirubin

    Values of liver enzymes will be measured: Total Bilirubin. Values will be reported in mg/dL

    Measured: 26 weeks

  8. Clinical Opiate Withdrawal Scale (COWS) scores trends

    Withdrawal symptoms scale- total score 0-48 with a lower score denoting no symptoms (better Outcomes) and higher score denoting more withdrawal symptoms

    Measured: 26 weeks

  9. Subjective Opiate Withdrawal Scale (SOWS) score trends

    Participant survey for how they are feeling during withdrawal period, score range from 0 to 64. Low score denotes no/less perceived symptoms (better outcomes) and higher score denotes high/ more personal perceived symptoms.

    Measured: 26 weeks

  10. Number or patients still in medication assisted therapy (MAT) clinic 6 months after trial period ends.

    Number of patients still in MAT clinics at 6 months

    Measured: 6 months

  11. Number of participants death

    Number of Participants deaths 6 months after initial participant consent is given.as measured by Vital Statistics database

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2018
  2. Study startJun 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Why it stopped: Funding for uninsured subjects could not be realized and staffing after COVID hit was also a problem.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients admitted to the WFBMC Medication-Assisted-Therapy (MAT) clinic with a diagnosis of moderate/severe Opioid-Use Disorders (OUD) who are more than 18 years old will be approached for enrollment in this study. Because of the nature of a pilot study, it's proposed a total of 30 patients, 15 in each group. Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day, the subject will be started on the treatment to which they are randomized, either Suboxone® SL or Sublocade®. Control group -Suboxone®SL: Patients assigned to this group will continue with their already established dose of Suboxone ®SL films for 24 weeks along with weekly therapy. Study drug-Sublocade® group: Patients assigned to this group will receive the study drug (subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. At the end of the 24-weeks subjects will continue the medication of their choice within the constraints of their insurance provider.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03744663
Sponsor's protocol ID
IRB00054516
Status last verified
Jun 2022
First submitted
9 Nov 2018
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.

    PubMed 26720857

  • Prevention CfDCa. Heroin Overdose Data. US Department of Health and Human Services. https://www.cdc.gov/drugoverdose/data/heroin.html. Published Jan 2017. Updated 2018-08-31T12:47:34Z. Accessed September 3 2018.

  • Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

    PubMed 28033313

  • Fleischauer AT, Ruhl L, Rhea S, Barnes E. Hospitalizations for Endocarditis and Associated Health Care Costs Among Persons with Diagnosed Drug Dependence - North Carolina, 2010-2015. MMWR Morb Mortal Wkly Rep. 2017 Jun 9;66(22):569-573. doi: 10.15585/mmwr.mm6622a1.

    PubMed 28594786

  • Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, Sanders KJ, Moore-Moravian L, Serrecchia J, Blankenship S, Ward JW, Holtzman D; Centers for Disease Control and Prevention (CDC). Increases in hepatitis C virus infection related to injection drug use among persons aged </=30 years - Kentucky, Tennessee, Virginia, and West Virginia, 2006-2012. MMWR Morb Mortal Wkly Rep. 2015 May 8;64(17):453-8.

    PubMed 25950251

  • Peters PJ, Pontones P, Hoover KW, Patel MR, Galang RR, Shields J, Blosser SJ, Spiller MW, Combs B, Switzer WM, Conrad C, Gentry J, Khudyakov Y, Waterhouse D, Owen SM, Chapman E, Roseberry JC, McCants V, Weidle PJ, Broz D, Samandari T, Mermin J, Walthall J, Brooks JT, Duwve JM; Indiana HIV Outbreak Investigation Team. HIV Infection Linked to Injection Use of Oxymorphone in Indiana, 2014-2015. N Engl J Med. 2016 Jul 21;375(3):229-39. doi: 10.1056/NEJMoa1515195.

    PubMed 27468059

  • Drug Enforcement Administration, Department of Justice.. Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder. Final rule. Fed Regist. 2018 Jan 23;83(15):3071-5.

    PubMed 29359892

  • Public policy statement on Office-Based Opioid Agonist Treatment (OBOT). J Addict Dis. 2005;24(3):153-61. doi: 10.1300/J069v24n03_12. No abstract available.

    PubMed 16186090

  • Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, Jacobs P, Teruya C, McLaughlin P, Wiest K, Cohen A, Ling W. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014 Jan;109(1):79-87. doi: 10.1111/add.12333. Epub 2013 Oct 9.

    PubMed 23961726

  • Kakko J, Svanborg KD, Kreek MJ, Heilig M. 1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trial. Lancet. 2003 Feb 22;361(9358):662-8. doi: 10.1016/S0140-6736(03)12600-1.

    PubMed 12606177

  • Yokell MA, Zaller ND, Green TC, Rich JD. Buprenorphine and buprenorphine/naloxone diversion, misuse, and illicit use: an international review. Curr Drug Abuse Rev. 2011 Mar;4(1):28-41. doi: 10.2174/1874473711104010028.

    PubMed 21466501

  • Winchell C. Cross-Discipline Team Leader Review and Summary Basis for Approval. In: Administration FD, ed: Federal Drug Administration; 2017.

  • (2017) USFDA. Press Announcements - FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. 2018.

  • Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.

    PubMed 11058673

  • Surgeon General's Report: Facing Addiction in America. In: Services USDoHaH, ed. 200 Independence Avenue SW Washington DC 20201: U.S. Department of Health and Human Services; 2017.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Suboxone® SL and Sublocade® in people with Opioid Use, run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Weeks patients continued in treatment during trial period (time frame: 26 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03744663, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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