A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA)
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|ClinicalTrials.gov Identifier: NCT03033732|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : June 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder||Drug: Methadone Drug: Buprenorphine-Naloxone||Phase 4|
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:
- Methadone provided via initial daily witnessed ingestion as per local guidelines.
- Buprenorphine/naloxone maintenance therapy provided via flexible take-home dose regimens dispensed as per the physician's discretion, once clinical stability is achieved.
Once 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||272 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)|
|Actual Study Start Date :||October 2, 2017|
|Actual Primary Completion Date :||March 31, 2020|
|Actual Study Completion Date :||December 31, 2020|
Opioid agonist treatment for opioid use disorder. Ingested in liquid oral form via strict initial daily witnessed ingestion as per local guidelines.
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.
Other Name: Methadose
Opioid agonist treatment for opioid use disorder. Ingested orally via sublingual tablet form, flexible take home dosing.
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.
Other Name: Suboxone
- Opioid Use [ Time Frame: 24 weeks ]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).
- Retention in treatment [ Time Frame: 24 weeks ]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.
- Opioid Agonist Treatment (OAT) Medication Adherence [ Time Frame: 24 weeks ]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.
- Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 weeks ]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.
- Patient Satisfaction [ Time Frame: 24 weeks ]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).
- Patient Engagement [ Time Frame: 24 weeks ]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.
- Quality of life [ Time Frame: 24 weeks ]Quality of Life (QoL) will be evaluated via the EQ5-D self-report questionnaires administered at Treatment Initiation and every 4 weeks.
- Pain [ Time Frame: 24 weeks ]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.
- Proportion of Participants who Initiate Taper [ Time Frame: 24 weeks ]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.
- Cost-effectiveness [ Time Frame: 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033732
|Calgary Opioid Dependency Program|
|Calgary, Alberta, Canada, T2R 0X7|
|Edmonton Opioid Dependency Program|
|Edmonton, Alberta, Canada, T5J 0G5|
|Canada, British Columbia|
|Rapid Access Addictions Clinic-St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Ontario Addiction Treatment Centres- Sudbury Clinic|
|Sudbury, Ontario, Canada, P3C 5K8|
|Addiction Medicine Service- Centre for Addictions and Mental Health|
|Toronto, Ontario, Canada, M6J 1H4|
|Centre de Recherche du CHUM|
|Montréal, Quebec, Canada, H2X 0A9|
|Centre de Recherche et d'Aide pour Narcomane|
|Montréal, Quebec, Canada, H2X 1S7|
|Principal Investigator:||Didier Jutras Aswad, MD||Canadian Research Initiative in Substance Misuse|
|Principal Investigator:||Maria E Socias, MD||British Columbia Centre on Substance Use|
|Principal Investigator:||Keith Ahamad, MD||British Columbia Centre on Substance use|
|Principal Investigator:||Bernard LeFoll, PhD||Centre for Addiction and Mental Health|
|Principal Investigator:||Ron Lim, MD||University of Calgary|
|Principal Investigator:||Julie Bruneau, MD||Centre hospitalier de l'Université de Montréal (CHUM)|
|Principal Investigator:||Evan Wood, MD||British Columbia Centre on Substance Use|
|Principal Investigator:||Cameron Wild, PhD||University of Alberta|
|Principal Investigator:||Jurgen Rehm, PhD||Centre for Addiction and Mental Health|