Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-05 @ 10:12 AM
Study NCT ID:
NCT03033732
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-11', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': '24 weeks', 'description': 'Quality of Life (QoL) will be evaluated via the EQ5-D self-report questionnaires administered at Treatment Initiation and every 4 weeks.'}, {'measure': 'Pain', 'timeFrame': '24 weeks', 'description': 'Pain will be assessed via Brief Pain Inventory self-report questionnaire at Screening to determine eligibility, Treatment Initiation and every 4 weeks for the 24 week intervention period.'}, {'measure': 'Proportion of Participants who Initiate Taper', 'timeFrame': '24 weeks', 'description': 'The proportion of patients who initiate taper will be assessed by using a standardized induction case report form completed via both pharmacy abstraction and self-report. The pharmacy record abstraction will collect information on opioid agonist treatment use and on the days between follow up visits, as well as information on end or switching of opioid agonist treatments, missing doses and reason any change in medication status or dose change. The participant will also be asked about his/her use of opioid agonist treatments in the past 2 weeks or since the last study visit collecting information similar to that information collected in the pharmacy abstraction.'}, {'measure': 'Cost-effectiveness', 'timeFrame': '24 weeks', 'description': 'Information on health service utilization will be collected at baseline and every 4 weeks for the 24-week intervention period. Items were selected from modules selected from the European Addiction Severity Index which collect self-report data on income, medical/medication status, healthcare provider visits, and criminal activity. This information will either be collected on paper source or entered by the participant directly into the Electronic Data Capture (EDC) system.'}], 'primaryOutcomes': [{'measure': 'Opioid Use', 'timeFrame': '24 weeks', 'description': 'Opioid use will be measured by the overall proportion of opioid-free urine drug screens (UDS) during the 24 weeks of the trial (excluding the assigned metabolites of opioid agonist treatments, as appropriate), with missing values defined as positive UDS (binary, laboratory assay).'}], 'secondaryOutcomes': [{'measure': 'Retention in treatment', 'timeFrame': '24 weeks', 'description': 'Retention in treatment is defined as the proportion of participants on assigned opioid agonist treatment (OAT) at the end of the study, as defined by having both a) an active prescription for the assigned OAT at week 24, and b) a positive UDS result for the assigned OAT at week 24.'}, {'measure': 'Opioid Agonist Treatment (OAT) Medication Adherence', 'timeFrame': '24 weeks', 'description': 'OAT medication adherence is defined as the proportion of assigned treatment doses received over the 24-week trial period assessed by both Pharmacy Abstraction and participant self-report.'}, {'measure': 'Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': '24 weeks', 'description': 'Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the duration of the trial. Adverse events and SAEs will be collected during study visits by means of open questions (e.g., has there been any changes to your health since the last study visit?). Also, the observation of clinically significant change in lab test results, fatal or non-fatal overdoses, and precipitated withdrawal symptoms from buprenorphine/naloxone inductions will be used to document AEs and SAEs. All AEs and SAEs will be documented using an AE Log in which the date and time of onset, the end date and time (i.e., when the AE was resolved or stabilized), the severity of the event, any action taken with respect to the study medication (e.g., no treatment or dose adjustment), and the relationship with study protocol or study medication will be recorded.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '24 weeks', 'description': 'Patient satisfaction to the assigned treatment will be recorded on the Client Satisfaction Questionnaire (CSQ-8) and will be administered at 4, 12, and 24 weeks (end of study).'}, {'measure': 'Patient Engagement', 'timeFrame': '24 weeks', 'description': 'Patient engagement in treatment will be measured through self-report questionnaires administered at Treatment Initiation, week 4, week 12, and week 24 visits. The primary measure of ongoing patient engagement will be administered at Treatment Initiation and every 2 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid agonist treatment', 'pragmatic', 'prescription opioid use', 'patient engagement'], 'conditions': ['Opioid Use Disorder']}, 'referencesModule': {'references': [{'pmid': '40874578', 'type': 'DERIVED', 'citation': "Bastien G, Abboud A, McAnulty C, Mahroug A, Le Foll B, Socias ME, Juteau LC, Dubreucq S, Jutras-Aswad D. Concordance Between Urine Drug Screening and Self-Reported Use in the Context of a Pragmatic Randomized-Controlled Trial in People with Prescription-Type Opioid Use Disorder: Concordance entre le depistage de drogues dans l'urine et l'usage autodeclare dans le contexte d'un essai pragmatique controle a repartition aleatoire chez des personnes presentant un trouble lie a l'usage d'opioides vendus sur ordonnance. Can J Psychiatry. 2026 Jan;71(1):41-52. doi: 10.1177/07067437251367180. Epub 2025 Aug 28."}, {'pmid': '39923043', 'type': 'DERIVED', 'citation': 'Bouthillier A, Bastien G, McAnulty C, Bakouni H, Le Foll B, Socias ME, Jutras-Aswad D. Opioid consumption frequency and its associations with potential life problems during opioid agonist treatment in individuals with prescription-type opioid use disorder: exploratory results from the OPTIMA Study. Harm Reduct J. 2025 Feb 8;22(1):14. doi: 10.1186/s12954-025-01157-4.'}, {'pmid': '38721650', 'type': 'DERIVED', 'citation': 'Langlois J, Fairbairn N, Jutras-Aswad D, Le Foll B, Lim R, Socias ME. Characterising methamphetamine/amphetamine use among opioid agonist therapy-seeking adults with prescription-type opioid use disorder in Canada. Drug Alcohol Rev. 2024 Nov;43(7):1905-1912. doi: 10.1111/dar.13863. Epub 2024 May 9.'}, {'pmid': '38580298', 'type': 'DERIVED', 'citation': 'Bastien G, Abboud A, McAnulty C, Elkrief L, Ledjiar O, Socias ME, Le Foll B, Bahji A, Brissette S, Marsan S, Jutras-Aswad D. Impact of Depressive Symptom Severity on Buprenorphine/Naloxone and Methadone Outcomes in People With Prescription-Type Opioid Use Disorder: Results From a Pragmatic Randomized Controlled Trial. J Dual Diagn. 2024 Jul-Sep;20(3):189-200. doi: 10.1080/15504263.2024.2329267. Epub 2024 Apr 5.'}, {'pmid': '38506171', 'type': 'DERIVED', 'citation': 'Socias ME, Cui Z, Le Foll B, Lei J, Stewart S, Anand R, Jutras-Aswad D. Sexually transmitted and blood-borne infection risk reduction with methadone and buprenorphine/naloxone among people with prescription-type opioid use disorder: Findings from a Canadian pragmatic randomized trial. HIV Med. 2024 Jul;25(7):817-825. doi: 10.1111/hiv.13636. Epub 2024 Mar 20.'}, {'pmid': '37697811', 'type': 'DERIVED', 'citation': 'Bahji A, Bastien G, Bach P, Choi J, Le Foll B, Lim R, Jutras-Aswad D, Socias ME. The Association Between Self-Reported Anxiety and Retention in Opioid Agonist Therapy: Findings From a Canadian Pragmatic Trial. Can J Psychiatry. 2024 Mar;69(3):172-182. doi: 10.1177/07067437231194385. Epub 2023 Sep 12.'}, {'pmid': '37003540', 'type': 'DERIVED', 'citation': 'Elkrief L, Bastien G, McAnulty C, Bakouni H, Hebert FO, Socias ME, Le Foll B, Lim R, Ledjiar O, Marsan S, Brissette S, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Differential effect of cannabis use on opioid agonist treatment outcomes: Exploratory analyses from the OPTIMA study. J Subst Use Addict Treat. 2023 Jun;149:209031. doi: 10.1016/j.josat.2023.209031. Epub 2023 Mar 30.'}, {'pmid': '36519188', 'type': 'DERIVED', 'citation': 'Bastien G, McAnulty C, Ledjiar O, Socias ME, Le Foll B, Lim R, Hassan AN, Brissette S, Marsan S, Talbot A, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Effects of Buprenorphine/Naloxone and Methadone on Depressive Symptoms in People with Prescription Opioid Use Disorder: A Pragmatic Randomised Controlled Trial. Can J Psychiatry. 2023 Aug;68(8):572-585. doi: 10.1177/07067437221145013. Epub 2022 Dec 14.'}, {'pmid': '36037586', 'type': 'DERIVED', 'citation': 'McAnulty C, Bastien G, Eugenia Socias M, Bruneau J, Le Foll B, Lim R, Brissette S, Ledjiar O, Marsan S, Talbot A, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial. Drug Alcohol Depend. 2022 Oct 1;239:109604. doi: 10.1016/j.drugalcdep.2022.109604. Epub 2022 Aug 17.'}, {'pmid': '35702828', 'type': 'DERIVED', 'citation': 'Jutras-Aswad D, Le Foll B, Ahamad K, Lim R, Bruneau J, Fischer B, Rehm J, Wild TC, Wood E, Brissette S, Gagnon L, Fikowski J, Ledjiar O, Masse B, Socias ME; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Flexible Buprenorphine/Naloxone Model of Care for Reducing Opioid Use in Individuals With Prescription-Type Opioid Use Disorder: An Open-Label, Pragmatic, Noninferiority Randomized Controlled Trial. Am J Psychiatry. 2022 Oct;179(10):726-739. doi: 10.1176/appi.ajp.21090964. Epub 2022 Jun 15.'}, {'pmid': '29627621', 'type': 'DERIVED', 'citation': 'Socias ME, Ahamad K, Le Foll B, Lim R, Bruneau J, Fischer B, Wild TC, Wood E, Jutras-Aswad D. The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale. Contemp Clin Trials. 2018 Jun;69:21-27. doi: 10.1016/j.cct.2018.04.001. Epub 2018 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for buprenorphine/naloxone. The OPTIMA study is designed with the intention to support patient-provider decision-making and evaluate health related outcomes with the overall aim of improving treatment outcomes through enhancing patient-centered approaches in clinical care.', 'detailedDescription': "This is a multicenter, open-label, 2-arm, randomized trial with a pragmatic design involving 276 individuals with prescription opioid use disorder. Participants will be randomized to receive either:\n\n1. Methadone provided via initial daily witnessed ingestion as per local guidelines.\n2. Buprenorphine/naloxone maintenance therapy provided via flexible take-home dose regimens dispensed as per the physician's discretion, once clinical stability is achieved.\n\nOnce randomized to a study medication and treatment initiation and induction has begun, study physicians and participants will discuss the treatment plans and procedures going forward. Once treatment initiation has taken place, the participant will attend study visits every 2 weeks (including collection of urine samples) for the 24-week intervention period. For all study sites, standardized guidelines exist and will be adhered to for the safe induction of both medications. Frequency of illicit opioid use, intensity of craving and other secondary endpoints will also be assessed via standardized questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be aged between 18 and 64 years of age inclusively;\n2. Prescription opioid use disorder (as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 criteria), which requires opioid agonist therapy as per the discretion of the physician;\n3. Female participants may be eligible if:\n\n 1. Is of non-childbearing potential, defined as (i) post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age); or (ii) documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy).\n 2. Is of childbearing potential, has a negative pregnancy test at screening and and agrees to use an acceptable method of birth control throughout study;\n4. Be willing to be randomized to 24 weeks of either methadone or buprenorphine/naloxone adapted model of care, and to be followed for the duration of the trial;\n5. Be able to provide written informed consent;\n6. Be willing to comply with study procedures;\n7. Be able to communicate in English or French.\n\nExclusion Criteria:\n\n1. Any disabling medical condition as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes the safe participation in the study or the ability to provide fully informed consent;\n2. Any disabling, unstable or acute mental condition that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent;\n3. Heroin reported as the most frequently used opioid in the past 30 days;\n4. Taken methadone or buprenorphine/naloxone for Opioid Use Disorder maintenance treatment in the four weeks prior to screening;\n5. Pain of sufficient severity as to require ongoing pain management with opioids;\n6. History of a severe adverse event, hypersensitivity reaction, or allergic reaction to either methadone or buprenorphine/naloxone;\n7. Pregnant, nursing, or planning to become pregnant during the study period;\n8. Currently taking or have taken an investigational drug in another study in the last 30 days, confirmed via self-report;\n9. Pending legal action or other reasons in the opinion of the study physician that might prevent completion of the study;\n10. Presence of a substance use disorder that, in the opinion of the study physician, precludes safe participation in the study (e.g. unstable or severe alcohol use disorder, unstable or severe benzodiazepine use disorder);\n11. Current treatment with medications that may interact with either methadone or buprenorphine/naloxone (e.g. Clonazepam, Benzodiazepines) OR anticipation that the patient may need to initiate such treatment during the trial that is deemed unsafe by the study physician or could prevent study completion;'}, 'identificationModule': {'nctId': 'NCT03033732', 'acronym': 'OPTIMA', 'briefTitle': 'A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Research Initiative in Substance Misuse'}, 'officialTitle': 'Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)', 'orgStudyIdInfo': {'id': 'CRISM 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Methadone', 'description': 'Opioid agonist treatment for opioid use disorder. Ingested in liquid oral form via strict initial daily witnessed ingestion as per local guidelines.', 'interventionNames': ['Drug: Methadone']}, {'type': 'OTHER', 'label': 'Buprenorphine/Naloxone', 'description': 'Opioid agonist treatment for opioid use disorder. Ingested orally via sublingual tablet form, flexible take home dosing.', 'interventionNames': ['Drug: Buprenorphine-Naloxone']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'otherNames': ['Methadose'], 'description': 'Methadone is a synthetic analgesic drug used as a substitute drug in the treatment of opioid use disorder. Methadone is administered via strict daily witnessed ingestion.', 'armGroupLabels': ['Methadone']}, {'name': 'Buprenorphine-Naloxone', 'type': 'DRUG', 'otherNames': ['Suboxone'], 'description': 'Buprenorphine/Naloxone is an opioid agonist treatment used to treat opioid use disorder. Buprenorphine/Naloxone is administered via flexible take home dosing once the patient has reached stabilization as per physician discretion.', 'armGroupLabels': ['Buprenorphine/Naloxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2R 0X7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Calgary Opioid Dependency Program', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5J 0G5', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Edmonton Opioid Dependency Program', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Rapid Access Addictions Clinic-St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'P3C 5K8', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ontario Addiction Treatment Centres- Sudbury Clinic', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'M6J 1H4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Addiction Medicine Service- Centre for Addictions and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche du CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 1S7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre de Recherche et d'Aide pour Narcomane", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Didier Jutras Aswad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Canadian Research Initiative in Substance Misuse'}, {'name': 'Maria E Socias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Centre on Substance Use'}, {'name': 'Keith Ahamad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Centre on Substance use'}, {'name': 'Bernard LeFoll, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}, {'name': 'Ron Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Julie Bruneau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}, {'name': 'Evan Wood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Centre on Substance Use'}, {'name': 'Cameron Wild, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}, {'name': 'Jurgen Rehm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Didier Jutras Aswad', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Didier Jutras Aswad - Principal Investigator', 'investigatorFullName': 'Didier Jutras Aswad', 'investigatorAffiliation': 'Canadian Research Initiative in Substance Misuse'}}}}