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

Opiate Addiction Clinical Trial

— H-SOAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01934751
• Other study ID #: BRIDGES
• Secondary ID: MOHLTC
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2013
• Last updated: December 10, 2014
• Start date: September 2013
• Est. completion date: April 2015

Study information

• Verified date: December 2014
• Source: Women's College Hospital
• Contact: Meldon Kahan, MDCCFP FRCPC
• Phone: 416-323-6400
• Email: meldon.kahan[@]wchospital.ca
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Addiction
• Alcoholism
• Behavior, Addictive
• Opiate Addiction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Women's College Hospital	St. Michael's Hospital, Toronto, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment retention	The number of subjects in each group that attend the addiction service, and the mean number of visits per subject.	12 months	No
Primary	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	36 months	No
Primary	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.	36 months	No
Primary	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.	12 months	No