PMID- 29627621
OWN - NLM
STAT- MEDLINE
DCOM- 20191017
LR  - 20200225
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Print)
IS  - 1551-7144 (Linking)
VI  - 69
DP  - 2018 Jun
TI  - The OPTIMA study, buprenorphine/naloxone and methadone models of care for the 
      treatment of prescription opioid use disorder: Study design and rationale.
PG  - 21-27
LID - S1551-7144(18)30035-1 [pii]
LID - 10.1016/j.cct.2018.04.001 [doi]
AB  - BACKGROUND: Rates of non-medical use of opioids, and opioid use disorders (OUD) 
      have been rising throughout North America. Methadone and buprenorphine/naloxone 
      are the recommended first-line treatment options for OUD in Canada. Most studies 
      to date have been conducted among heroin users, in controlled settings, and using 
      similar strict dosing schedules (i.e., daily witnessed ingestion) despite 
      buprenorphine/naloxone's superior safety profile, which allows a more flexible 
      take-home dosing schedule. This study was designed to assess the relative 
      effectiveness of buprenorphine/naloxone- and methadone-based models of opioid 
      agonist therapy (OAT) for the treatment of prescription opioid use disorder 
      (POUD) in routine clinical care. METHODS: OPTIMA is a multicenter, open-label, 
      pragmatic, randomized, two-arm, non-inferiority, 24-week study comparing the 
      relative effectiveness of buprenorphine/naloxone (provided via flexible take-home 
      doses) to methadone (provided via daily witnessed ingestion) models of OAT for 
      the treatment of POUD. Approximately 276 non-pregnant adults meeting DSM-5 
      criteria for OUD, currently not in OAT, will be randomized across 7 Canadian 
      sites. The primary outcome is reduction of non-medical opioid use, measured by 
      bi-weekly urine drug screens during the 24-week study period. Secondary outcomes 
      include treatment retention and satisfaction, safety, medication adherence, and 
      patient engagement. DISCUSSION: The OPTIMA study is the first randomized clinical 
      trial to compare the relative effectiveness of buprenorphine/naloxone (flexible 
      take-home doses) versus methadone (daily witnessed ingestion) models of OAT for 
      POUD in real-world clinical settings. This study will generate urgently needed 
      evidence towards treatment options to guide the health system response to the 
      ongoing opioid crisis. CLINICAL TRIAL REGISTRATION: NCT03033732.
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Socias, M Eugenia
AU  - Socias ME
AD  - British Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard 
      Street, Vancouver, BC V6Z 1Y6, Canada; Department of Medicine, Faculty of 
      Medicine, University of British Columbia, 608-1081 Burrard Street, Vancouver, BC 
      V6Z 1Y6, Canada. Electronic address: esocias@cfenet.ubc.ca.
FAU - Ahamad, Keith
AU  - Ahamad K
AD  - British Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard 
      Street, Vancouver, BC V6Z 1Y6, Canada; Department of Family Practice, Faculty of 
      Medicine, University of British Columbia, 3rd Floor David Strangway Building, 
      5950 University Boulevard, Vancouver, BC V6T 1Z3, Canada.
FAU - Le Foll, Bernard
AU  - Le Foll B
AD  - Centre for Addiction and Mental Health, 33 Russell Street, Toronto, ON M5S 2S1, 
      Canada; Department of Family and Community Practice, University of Toronto, 500 
      University Avenue, 5th floor, Toronto, ON M5G 1V7, Canada; Department of 
      Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, ON M5T 
      1R8, Canada.
FAU - Lim, Ron
AU  - Lim R
AD  - Department of Medicine, Cumming School of Medicine, University of Calgary, 2500 
      University Drive NW, Calgary, AB T2N 1N4, Canada.
FAU - Bruneau, Julie
AU  - Bruneau J
AD  - Research Center, Centre hospitalier de l'Universite de Montreal (CRCHUM), 900 
      Saint Denis Street, Montreal, QC H2X 0A9, Canada; Department of Family Medicine, 
      Faculty of Medicine, Universite de Montreal, C.P. 6128, Succursale Centre-ville, 
      Montreal, QC H3C 3J7, Canada.
FAU - Fischer, Benedikt
AU  - Fischer B
AD  - Centre for Addiction and Mental Health, 33 Russell Street, Toronto, ON M5S 2S1, 
      Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th 
      floor, Toronto, ON M5T 1R8, Canada; Centre for Applied Research in Mental Health 
      and Addiction, Faculty of Health Sciences, Simon Fraser University, Suite 2400, 
      515 W. Hastings Street, Vancouver, BC V6B 5K3, Canada.
FAU - Wild, T Cameron
AU  - Wild TC
AD  - School of Public Health, University of Alberta, 3-300 Edmonton Clinic Health 
      Academy 11405-87 Av, Edmonton, AL T6G 1C9, Canada.
FAU - Wood, Evan
AU  - Wood E
AD  - British Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard 
      Street, Vancouver, BC V6Z 1Y6, Canada; Department of Medicine, Faculty of 
      Medicine, University of British Columbia, 608-1081 Burrard Street, Vancouver, BC 
      V6Z 1Y6, Canada.
FAU - Jutras-Aswad, Didier
AU  - Jutras-Aswad D
AD  - Department of Medicine, Cumming School of Medicine, University of Calgary, 2500 
      University Drive NW, Calgary, AB T2N 1N4, Canada; Department of Psychiatry, 
      Faculty of Medicine, Universite de Montreal, C.P. 6128, Succursale Centre-ville, 
      Montreal, QC H3C 3J7, Canada.
LA  - eng
SI  - ClinicalTrials.gov/NCT03033732
GR  - R25 DA037756/DA/NIDA NIH HHS/United States
GR  - CIS-144301/CIHR/Canada
GR  - CIS-144302/CIHR/Canada
GR  - CIS-144303/CIHR/Canada
GR  - CIS-144304/CIHR/Canada
GR  - SMN-139148/CIHR/Canada
GR  - SMN-139149/CIHR/Canada
GR  - SMN-139150/CIHR/Canada
GR  - SMN-139151/CIHR/Canada
PT  - Journal Article
PT  - Multicenter Study
PT  - Pragmatic Clinical Trial
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180405
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Buprenorphine, Naloxone Drug Combination)
RN  - 0 (Narcotic Antagonists)
RN  - UC6VBE7V1Z (Methadone)
SB  - IM
MH  - Adult
MH  - Analgesics, Opioid/administration & dosage
MH  - Behavior Observation Techniques
MH  - Buprenorphine, Naloxone Drug Combination/*administration & dosage
MH  - Canada
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Methadone/*administration & dosage
MH  - Narcotic Antagonists/administration & dosage
MH  - Needs Assessment
MH  - Opiate Substitution Treatment/methods/psychology
MH  - *Opioid-Related Disorders/diagnosis/psychology/therapy
MH  - Prescription Drug Overuse/*prevention & control
MH  - Substance Abuse Detection/methods
PMC - PMC6625801
MID - NIHMS1039731
OTO - NOTNLM
OT  - Buprenorphine/naloxone
OT  - Canada
OT  - Fentanyl
OT  - Methadone
OT  - Opioid agonist therapy
OT  - Opioid use disorder
OT  - Prescription opioids
EDAT- 2018/04/09 06:00
MHDA- 2019/10/18 06:00
PMCR- 2019/07/12
CRDT- 2018/04/09 06:00
PHST- 2018/01/28 00:00 [received]
PHST- 2018/04/02 00:00 [revised]
PHST- 2018/04/03 00:00 [accepted]
PHST- 2018/04/09 06:00 [pubmed]
PHST- 2019/10/18 06:00 [medline]
PHST- 2018/04/09 06:00 [entrez]
PHST- 2019/07/12 00:00 [pmc-release]
AID - S1551-7144(18)30035-1 [pii]
AID - 10.1016/j.cct.2018.04.001 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2018 Jun;69:21-27. doi: 10.1016/j.cct.2018.04.001. Epub 2018 
      Apr 5.