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

NCT01934751 | Unknown

• 2 other identifiers: BRIDGESMOHLTC
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Addiction; Opiate Addiction

Outcome Measures

Primary Outcomes (4)

• Treatment retention

  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

  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

  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

  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

Study Arms (2)

Opioid dependent

OTHER

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); Other: Rapid Intervention (RI)

Alcohol dependent

OTHER

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); Other: Rapid Intervention (RI)

Interventions

Delayed Intervention (DI) OTHER

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.

Alcohol dependent; Opioid dependent

Rapid Intervention (RI) OTHER

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.

Alcohol dependent; Opioid dependent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Women's College Hospital: lead
• Unity Health Toronto: collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B1, Canada

RECRUITING

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MeSH Terms

Conditions

Alcoholism; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Meldon Kahan, MDCCFP FRCPC

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Anita Srivastava, MD MSc CCFP

  St. Joseph's Health Centre Toronto

  PRINCIPAL INVESTIGATOR

• Rajesh Gupta, MD MEd FRCPC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Leslie Buckley, MD, MPH

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meldon Kahan, MDCCFP FRCPC

CONTACT

416-323-6400; meldon.kahan@wchospital.ca

Kate Hardy, MSW RSW

CONTACT

416-323-6400; kate.hardy@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director, Substance Use Service

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

CA (1)