Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction (H-SOAP)

December 10, 2014 updated by: Meldon Kahan, Women's College Hospital

Randomized Controlled Trial on the Effectiveness of Immediate Versus Delayed Access to Hospital-based Addiction Services

Hypothesis: Patients who are addicted to opioids or alcohol will have reduced substance use, health care utilization if they have immediate and convenient access to pharmacotherapy and addiction counselling.

Summary: This randomized trial will compare two different interventions for 124 alcohol and opioid-addicted patients admitted to either Women's Own Detox (WOD) at the University Health Network or the Withdrawal Management Service (WMS) at Saint Michael's Hospital (SMH. The Delayed Intervention group will receive a card with contact information for the St. Michael's Hospital and Women's College Hospital addiction medicine services. The Rapid Intervention group will be seen by an addiction physician from one of these services, within a day or two of their admission to the WOD or the SMH WMS. The addiction physician will prescribe buprenorphine or anti-alcohol medications, and the physician, nurse and/or therapist will provide ongoing counseling, follow-up and shared care with the family physician. Outcomes (measured at 6 and 12 months) include treatment retention, health care utilization and cost, medications prescribed, and alcohol and opioid use.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 1B1
        • Recruiting
        • Women's College Hospital
        • Contact:
        • Principal Investigator:
          • Meldon Kahan, MDCCFP FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a possible alcohol use disorder, as determined by a score of 8 or above on the AUDIT (Alcohol Use Disorders Identification Test); or, a possible opioid use disorder, as determined by positive responses on the eligibility form: within the past 30 days, opioid use has been a problem, and at least one harmful consequence of opioid use has been present, eg withdrawal symptoms, or problems with family, friends, work, money etc. If the addiction physician who assesses the patient at the first visit to the addiction service concludes that these screening tests were falsely positive and the patient does not have an alcohol or opioid use disorder, the physician will contact the RA to discharge the patient from the study.
  • Interested in receiving treatment at an addiction medicine service.
  • is alert and able to provide informed consent (ie is not confused, agitated, hostile, intoxicated, sedated or in severe withdrawal)
  • Has attended a hospital Emergency Department or has been admitted to hospital in Ontario within the past year.
  • Can speak and read English.

Exclusion Criteria:

  • Pregnant
  • Currently receiving methadone or buprenorphine treatment
  • Cognitively impaired
  • Unable to speak or read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Opioid dependent
Subjects with a possible opioid use disorder, as determined by positive responses on the eligibility form: has used opioids within the past 30 days, opioid use has been a problem, and at least one harmful consequence of opioid use has been present (eg. withdrawal symptoms, or problems with family, friends, work, money etc.).
Other: Delayed Intervention (DI)
Subjects randomized to the DI group will be given a card with the number for the usual Substance Use Service, where they will be seen within 2-4 weeks (standard practice). If they attend the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
Other: Rapid Intervention (RI)
Subjects randomized to the RI group will be seen in the Substance Use Service at within 1-2 days of study enrolment. The Research Assistant will book the appointment and arrange transportation. At the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
Other: Alcohol dependent
Patients who indicate they have a problem with alcohol will be asked to complete the AUDIT, a validated, 10-item instrument that measures the severity of an alcohol problem. The AUDIT enquires about core features of alcohol dependence, such as failure to fulfill obligations. A score of 8 or more indicates possible alcohol dependence.
Other: Delayed Intervention (DI)
Subjects randomized to the DI group will be given a card with the number for the usual Substance Use Service, where they will be seen within 2-4 weeks (standard practice). If they attend the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
Other: Rapid Intervention (RI)
Subjects randomized to the RI group will be seen in the Substance Use Service at within 1-2 days of study enrolment. The Research Assistant will book the appointment and arrange transportation. At the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment retention
Time Frame: 12 months
The number of subjects in each group that attend the addiction service, and the mean number of visits per subject.
12 months
Healthcare utilization and cost
Time Frame: 36 months
For each subject the ICES (Institute for Clinical Evaluative Sciences) linked administrative databases will be used to track, from 24 months before to 12 months after the initial visit: a) the number of hospitalizations and number of hospital days (Canadian Institute for Health Information (CIHI) Discharge Abstract Database), b) Emergency Department (ED) visits (CIHI National Ambulatory Care Reporting System), c) primary care visits and outpatient laboratory services (Ontario Health Information Plan Database). During the monthly telephone calls and at the 6 and 12 month visits, the Research Assistant (RA) will ask subjects about recent ED visits, hospitalizations and outpatient medical visits
36 months
Prescriptions
Time Frame: 36 months
For patients eligible for pharmacotherapy, ICES will be used to evaluate pre-post (prescribing from 24 months before study entry to 12 months after) changes in opioid and benzodiazepine prescribing, and prescribing of buprenorphine, methadone, and anti-alcohol drugs.
36 months
Substance use
Time Frame: 12 months
The research assistant will conduct interviews at baseline, 6, and 12 months during which subjects will be asked about changes in substance use.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

University Health Network, Toronto
Unity Health Toronto

Investigators

  • Principal Investigator: Meldon Kahan, MDCCFP FRCPC, Women's College Hospital
  • Principal Investigator: Anita Srivastava, MD MSc CCFP, St. Joseph's Health Centre
  • Principal Investigator: Rajesh Gupta, MD MEd FRCPC, Unity Health Toronto
  • Principal Investigator: Leslie Buckley, MD, MPH, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIDGES
  • MOHLTC (Other Identifier: University of Toronto, Ontario Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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