- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02180659
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants (PRO-814)
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Multicenter Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily Maintenance Dose of 8 mg or Less of Sublingual Buprenorphine or Buprenorphine/Naloxone to Four Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine (BPN), to 4 Probuphine implants compared to SL BPN.
The secondary objective of the study is to confirm safety of 4 Probuphine implants in adult outpatients with opioid dependence who are clinically stabilized on 8 mg or less of SL BPN.
Przegląd badań
Status
Warunki
Szczegółowy opis
This is a randomized, double-blind, double-dummy, active-controlled multi-center study to evaluate the efficacy of transition to four 80 mg Probuphine implants in adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of SL BPN. The study will include 3 Phases; Screening, Maintenance and Follow-up.
Medical and eligibility screening should occur within 2 weeks of the first Maintenance Phase visit. The Screening Visit will include standard medical screening procedures, complete medical/psychosocial history, urine toxicology and detailed substance use and treatment history.
All subjects who have provided written informed consent and have met the other study entry criteria will be eligible for randomization. Following confirmation of eligibility, subjects will be randomized to one of two treatment groups in a 1:1 ratio:
- Treatment Group A: Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
- Treatment Group B: Four 80 mg Probuphine implants + daily SL placebo tablets
Implants will be surgically inserted on Day 1 (Baseline and Initiation of Study Drugs Visit). On Post-Implant Visit, additional follow-up safety and implant assessment procedures will be conducted. Subjects will return for monthly study visits on Weeks 4, 8, 12, 16, 20, and 24 (End of Treatment Visit). In addition to the monthly scheduled visits, subjects will provide 4 random urine toxicology samples throughout the 24-week treatment period.
A total of 10 urine toxicology samples will be collected; 6 at scheduled visits (1 per month) and 4 at random urine toxicology visits throughout the 24-week treatment period. At the scheduled visits, other assessments of efficacy and safety will be collected. Implants will be removed at the End of Treatment Visit on Week 24.
Following Week 24, subjects will be re-transitioned back to usual care (pre-trial), as needed. During Week 25, telephone contact will be made with all subjects. and Week 26 will include an on-site visit to the clinic for final follow-up assessments (Follow-up Visit).
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Subject must provide written informed consent prior to the conduct of any study-related procedures.
- Male or female, 18-65 years of age, inclusive.
- Primary diagnosis of opioid dependence (DSM-IV-TR).
Subject is considered clinically stable by their treating healthcare provider and confirmed by the following:
- Subject must be on SL BPN treatment for at least 6 months.
- Subject must have been on a SL BPN dose of 8 mg or less daily for at least the last 90 days prior to Screening.
- No positive urine toxicology results for illicit opioids in the last 90 days.
- Free from significant withdrawal symptoms (score of ≤ 5 on the Clinical Opiate Withdrawal Scale [COWS]), as measured at the Screening Visit.
- Female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening Visit to Follow-Up Visit).
Exclusion Criteria:
- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).
- Current diagnosis of chronic pain syndrome requiring chronic opioid treatment, or conditions associated with acute episodic flares that require opioid treatment.
- Pregnant or lactating or planning to become pregnant during the study.
- Hypersensitivity or allergy to ethylene vinyl acetate (EVA)-containing substances or naloxone.
- Recent scarring or tattoos on their upper arms, or a history of keloid scarring.
- Requires current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).
- History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin.
- Current DSM-IV-TR diagnosis for substance dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, cocaine).
- Significant symptoms or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent.
- Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study.
- Any pending legal action that could prohibit participation or compliance in the study.
- Exposure to any investigational drug within the 8 weeks prior to Screening.
- Aspartate aminotransferase levels ≥3 X the upper limit of normal, alanine aminotransferase levels ≥ 3 X the upper limit of normal, total bilirubin ≥ 1.5 X the upper limit of normal, or creatinine ≥ 1.5 X upper limit of normal on the Screening laboratory assessments.
- Clinically significant low platelet count on the Screening laboratory assessments, according to the Investigator.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: buprenorphine implants + placebo tablets
Four 80 mg Probuphine implants + daily SL placebo tablets
|
|
Aktywny komparator: buprenorphine tablets + placebo implants
Daily SL BPN tablets (≤8 mg/daily) + four placebo implants
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use.
Ramy czasowe: 24 weeks
|
The primary efficacy endpoint is a responder analysis.
A subject will be designated as a responder (meaning they have maintained stability) if they have no more than 2 of 6 months with any evidence of illicit opioid use.
Evidence of illicit opioid use is defined as a positive opioid urine toxicology result or self-reported illicit opioid use.
|
24 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Percent of Subjects With no Urine Illicit Opioid Use by Month;
Ramy czasowe: 24 weeks
|
The secondary outcome is the percent of subjects with no urine illicit opioid use by month.
|
24 weeks
|
Number of Participants With Evidence of Urine Illicit Opioid Use by Month
Ramy czasowe: 24 weeks
|
Secondary efficacy endpoint measures number of participants with evidence of urine illicit opioid use by month.
|
24 weeks
|
Percent of Subjects With no Self-reported Illicit Drug Use by Month
Ramy czasowe: 24 weeks
|
Subjects in the ITT population with no self-reported use of any illicit drugs (opioid or non-opioid) by month of evaluation
|
24 weeks
|
Measures of Craving: Desire to Use Visual Analogue Scale (VAS)
Ramy czasowe: 24 weeks
|
The secondary outcome of measures of craving: desire to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no desire, and 100 mm is strongest possible desire.
|
24 weeks
|
Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)
Ramy czasowe: 24 weeks
|
The secondary outcome measures the change in baseline in the Clinical opiate withdrawal scale (COWS), which is a scale consisting of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale with higher scores associated with greater withdrawal symptoms.
A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48.
Withdrawal severity was classified, based on the total score, as follows: 0-4=none/normal, 5-12=mild, 13-24=moderate, 25-36=moderately severe, more than 36=severe withdrawal.
|
24 weeks
|
Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)
Ramy czasowe: 24 weeks
|
The secondary outcome measures the change in baseline in the subjective opioid withdrawal scale (SOWS), which is a scale which is a subject self-assessment of withdrawal symptoms.
The scale consists of 16 questions that rate the intensity of withdrawal from 0 (not at all) to 4 (extremely) with a cumulative score ranging from 0-64 (0 =not at all, 64=extremely)
|
24 weeks
|
Measures of Craving: Need to Use Visual Analogue Scale (VAS)
Ramy czasowe: 24 weeks
|
The secondary outcome of measures of craving: Need to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no need, and 100 mm is strongest possible need.
|
24 weeks
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia wywołane chemicznie
- Zaburzenia związane z substancjami
- Zaburzenia związane z narkotykami
- Zaburzenia związane z opioidami
- Fizjologiczne skutki leków
- Depresanty ośrodkowego układu nerwowego
- Agenty obwodowego układu nerwowego
- Środki przeciwbólowe
- Agenci systemu sensorycznego
- Leki przeciwbólowe, Opioidy
- Narkotyki
- Narkotyczni antagoniści
- Buprenorfina
Inne numery identyfikacyjne badania
- PRO-814
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Uzależnienie od opioidów
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Alza Corporation, DE, USAZakończony
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Medical University of WarsawNieznanyBól porodowy | Znieczulenie, zewnątrzoponowe | OpioidPolska
-
Finnish Institute for Health and WelfareZakończonyNalokson | Hazard | Rozpylać | OpioidFinlandia
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Aswan UniversityRekrutacyjnyCesarskie cięcie | Świąd | Wlew lidokainy | Neuroksjalny opioidEgipt
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University of SaskatchewanZakończonyBól porodowy | Ból położniczy | Indukcja płodu/noworodka dotkniętego porodem | Zewnątrzoponowe | Problemy znieczulenia położniczego | OpioidKanada
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Fujian Cancer HospitalNieznanyOpioid, umiarkowany ból nowotworowy, transdermalny fentanyl, 12,5 ug/h, nieleczony opioidami
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VA Office of Research and DevelopmentRekrutacyjnyUzależnienie, OpioidStany Zjednoczone
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Texas Christian UniversityUniversity of New Mexico; Loyola UniversityRekrutacyjnyUzależnienie, OpioidStany Zjednoczone
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Salem Anaesthesia Pain ClinicRekrutacyjnyZaburzenia nastroju; Opioid | Bezsenność nastrojuKanada
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University of California, Los AngelesJeszcze nie rekrutacjaUzależnienie, Opioid
Badania kliniczne na Buprenorphine implant
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University of Sao PauloZakończonyZaćma | AstygmatyzmBrazylia
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ZimVieZakończonyCzęściowe bezzębie | Choroba zębaStany Zjednoczone
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Mentor Worldwide, LLCWycofanePowiększenie | Rewizja rozszerzenia | Ogólne powiększenie piersi | Inwolucja po laktacji | AsymetriaStany Zjednoczone
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Medical University of GrazRekrutacyjnyNatychmiastowa implantacja dwuczęściowych implantów dentystycznych z tlenku cyrkonuAustria
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ZimVieZakończonyCzęściowe bezzębie | Choroba zębaKolumbia
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ZimVieZakończonyCzęściowe bezzębie | Choroba zębaChile
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Cairo UniversityJeszcze nie rekrutacjaBezzębny; Wyrostek zębodołowy, atrofia
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ZimVieZakończonyCzęściowe bezzębie | Choroba zębaChile
-
Nobel BiocareZakończonyCzęściowe bezzębie | Całkowite bezzębie
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Cairo UniversityJeszcze nie rekrutacjaImplant dentystyczny nie powiódł się | Reakcja w miejscu implantu