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

Primary Purpose

Alcohol Addiction, Opiate Addiction

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Delayed Intervention (DI)

Rapid Intervention (RI)

About this trial

This is an interventional treatment trial for Alcohol Addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Women's College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Opioid dependent

Alcohol dependent

Arm Description

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.).

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.

Outcomes

Primary Outcome Measures

Treatment retention

The number of subjects in each group that attend the addiction service, and the mean number of visits per subject.

Healthcare utilization and cost

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

Prescriptions

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.

Substance use

The research assistant will conduct interviews at baseline, 6, and 12 months during which subjects will be asked about changes in substance use.

Secondary Outcome Measures

Full Information

NCT ID

NCT01934751

First Posted

August 29, 2013

Last Updated

December 10, 2014

Sponsor

Women's College Hospital

Collaborators

Unity Health Toronto, University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01934751

Brief Title

Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction

Acronym

H-SOAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Women's College Hospital

Collaborators

Unity Health Toronto, University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Addiction, Opiate Addiction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Opioid dependent

Arm Type

Other

Arm Description

Arm Title

Alcohol dependent

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Delayed Intervention (DI)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Rapid Intervention (RI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Treatment retention

Description

The number of subjects in each group that attend the addiction service, and the mean number of visits per subject.

Time Frame

12 months

Title

Healthcare utilization and cost

Description

Time Frame

36 months

Title

Prescriptions

Description

Time Frame

36 months

Title

Substance use

Description

The research assistant will conduct interviews at baseline, 6, and 12 months during which subjects will be asked about changes in substance use.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meldon Kahan, MDCCFP FRCPC

Phone

416-323-6400

Ext

7511

meldon.kahan@wchospital.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Kate Hardy, MSW RSW

Phone

416-323-6400

Ext

7511

kate.hardy@wchospital.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meldon Kahan, MDCCFP FRCPC

Organizational Affiliation

Women's College Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anita Srivastava, MD MSc CCFP

Organizational Affiliation

St. Joseph's Health Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rajesh Gupta, MD MEd FRCPC

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leslie Buckley, MD, MPH

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's College Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S 1B1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kahan

meldon.kahan@wchospital.ca

First Name & Middle Initial & Last Name & Degree

Meldon Kahan, MDCCFP FRCPC

12. IPD Sharing Statement

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Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction

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