Alcohol AddictionH-SOAPNCT01934751
Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction
A study testing Delayed Intervention (DI) and Rapid Intervention (RI) in people with Alcohol Addiction and Opiate Addiction, run by Women's College Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Addiction, Opiate Addiction
- What is being tested?
- Delayed Intervention (DI) and Rapid Intervention (RI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant
- Currently receiving methadone or buprenorphine treatment
- Cognitively impaired
- Unable to speak or read English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B1
Kahan, meldon.kahan@wchospital.ca
Meldon Kahan, MDCCFP FRCPC
About this study
Official title: 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.
- Conditions
- Alcohol Addiction, Opiate Addiction
- Being tested
- Delayed Intervention (DI), Rapid Intervention (RI)
- Medical subject headings
- Alcoholism, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.). Receives: 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. Receives: Other: Delayed Intervention (DI); Other: Rapid Intervention (RI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention
The number of subjects in each group that attend the addiction service, and the mean number of visits per subject.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Alcohol AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, University Health Network, Toronto
- Responsible party
- Principal investigator, Meldon Kahan, Women's College Hospital
- Investigators
- Meldon Kahan, MDCCFP FRCPC, Principal investigator, Women's College HospitalAnita Srivastava, MD MSc CCFP, Principal investigator, St. Joseph's Health Centre TorontoRajesh Gupta, MD MEd FRCPC, Principal investigator, Unity Health TorontoLeslie Buckley, MD, MPH, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934751
- Sponsor's protocol ID
- BRIDGES
- Other IDs
- MOHLTC
- Acronym
- H-SOAP
- Status last verified
- Dec 2014
- First submitted
- 29 Aug 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shield, K. D., T. Kehoe, B. Taylor, J. Patra and J. Rehm (2011).
Taylor B, Rehm J, Patra J, Popova S, Baliunas D. Alcohol-attributable morbidity and resulting health care costs in Canada in 2002: recommendations for policy and prevention. J Stud Alcohol Drugs. 2007 Jan;68(1):36-47. doi: 10.15288/jsad.2007.68.36.
PubMed 17149516Center for Disease Control.
Dhalla IA, Mamdani MM, Sivilotti ML, Kopp A, Qureshi O, Juurlink DN. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ. 2009 Dec 8;181(12):891-6. doi: 10.1503/cmaj.090784. Epub 2009 Dec 7.
PubMed 19969578Domingo A, Anto JM, Cami J. Epidemiological surveillance of opioid-related episodes in an emergency room of Barcelona, Spain (1979-1989). Br J Addict. 1991 Nov;86(11):1459-66. doi: 10.1111/j.1360-0443.1991.tb01731.x.
PubMed 1777740Perez Gonzalez K, Domingo-Salvany A, Hartnoll R. [The characteristics of opiate users seen in an emergency service]. Gac Sanit. 1999 Mar-Apr;13(2):88-95. doi: 10.1016/s0213-9111(99)71332-4. Spanish.
PubMed 10354528Gowing, L., R. Ali and J. M. White (2009).
Hoffman, K. A., J. H. Ford, C. J. Tillotson, D. Choi and D. McCarty (2011).
Aszalos R, McDuff DR, Weintraub E, Montoya I, Schwartz R. Engaging hospitalized heroin-dependent patients into substance abuse treatment. J Subst Abuse Treat. 1999 Jul-Sep;17(1-2):149-58. doi: 10.1016/s0740-5472(98)00075-0.
PubMed 10435263Shanahan CW, Beers D, Alford DP, Brigandi E, Samet JH. A transitional opioid program to engage hospitalized drug users. J Gen Intern Med. 2010 Aug;25(8):803-8. doi: 10.1007/s11606-010-1311-3. Epub 2010 Mar 17.
PubMed 20237960Miller, P. M., S. W. Book and S. H. Stewart (2011).
Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Benefit-cost analysis of brief physician advice with problem drinkers in primary care settings. Med Care. 2000 Jan;38(1):7-18. doi: 10.1097/00005650-200001000-00003.
PubMed 10630716Alford DP, LaBelle CT, Kretsch N, Bergeron A, Winter M, Botticelli M, Samet JH. Collaborative care of opioid-addicted patients in primary care using buprenorphine: five-year experience. Arch Intern Med. 2011 Mar 14;171(5):425-31. doi: 10.1001/archinternmed.2010.541.
PubMed 21403039Soeffing JM, Martin LD, Fingerhood MI, Jasinski DR, Rastegar DA. Buprenorphine maintenance treatment in a primary care setting: outcomes at 1 year. J Subst Abuse Treat. 2009 Dec;37(4):426-30. doi: 10.1016/j.jsat.2009.05.003. Epub 2009 Jun 23.
PubMed 19553061Mark TL, Montejano LB, Kranzler HR, Chalk M, Gastfriend DR. Comparison of healthcare utilization among patients treated with alcoholism medications. Am J Manag Care. 2010;16(12):879-88.
PubMed 21348558
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effectiveness of Immediate Versus Delayed Access to Hospital-based Addiction Services
- ClinicalTrials.gov ID
- NCT01934751
- Acronym / sponsor ID
- H-SOAP / BRIDGES
- Conditions
- Alcohol Addiction, Opiate Addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Unity Health Toronto, University Health Network, Toronto
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid dependent | Other | Other: Delayed Intervention (DI), Other: Rapid Intervention (RI)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.). |
| Alcohol dependent | Other | Other: Delayed Intervention (DI), Other: Rapid Intervention (RI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant
- Currently receiving methadone or buprenorphine treatment
- Cognitively impaired
- Unable to speak or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Alcohol dependent, Opioid dependent |
| 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, Opioid dependent |
Primary outcome
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.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- BackgroundShield, K. D., T. Kehoe, B. Taylor, J. Patra and J. Rehm (2011).
- Background: PubMed 17149516Taylor B, Rehm J, Patra J, Popova S, Baliunas D. Alcohol-attributable morbidity and resulting health care costs in Canada in 2002: recommendations for policy and prevention. J Stud Alcohol Drugs. 2007 Jan;68(1):36-47. doi: 10.15288/jsad.2007.68.36.
- BackgroundCenter for Disease Control.
- Background: PubMed 19969578Dhalla IA, Mamdani MM, Sivilotti ML, Kopp A, Qureshi O, Juurlink DN. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ. 2009 Dec 8;181(12):891-6. doi: 10.1503/cmaj.090784. Epub 2009 Dec 7.
- Background: PubMed 1777740Domingo A, Anto JM, Cami J. Epidemiological surveillance of opioid-related episodes in an emergency room of Barcelona, Spain (1979-1989). Br J Addict. 1991 Nov;86(11):1459-66. doi: 10.1111/j.1360-0443.1991.tb01731.x.
- Background: PubMed 10354528Perez Gonzalez K, Domingo-Salvany A, Hartnoll R. [The characteristics of opiate users seen in an emergency service]. Gac Sanit. 1999 Mar-Apr;13(2):88-95. doi: 10.1016/s0213-9111(99)71332-4. Spanish.
- BackgroundGowing, L., R. Ali and J. M. White (2009).
- BackgroundHoffman, K. A., J. H. Ford, C. J. Tillotson, D. Choi and D. McCarty (2011).
- Background: PubMed 10435263Aszalos R, McDuff DR, Weintraub E, Montoya I, Schwartz R. Engaging hospitalized heroin-dependent patients into substance abuse treatment. J Subst Abuse Treat. 1999 Jul-Sep;17(1-2):149-58. doi: 10.1016/s0740-5472(98)00075-0.
- Background: PubMed 20237960Shanahan CW, Beers D, Alford DP, Brigandi E, Samet JH. A transitional opioid program to engage hospitalized drug users. J Gen Intern Med. 2010 Aug;25(8):803-8. doi: 10.1007/s11606-010-1311-3. Epub 2010 Mar 17.
- BackgroundMiller, P. M., S. W. Book and S. H. Stewart (2011).
- Background: PubMed 10630716Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Benefit-cost analysis of brief physician advice with problem drinkers in primary care settings. Med Care. 2000 Jan;38(1):7-18. doi: 10.1097/00005650-200001000-00003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meldon Kahan, MDCCFP FRCPC principal investigator
Women's College Hospital
Anita Srivastava, MD MSc CCFP principal investigator
St. Joseph's Health Centre Toronto
Rajesh Gupta, MD MEd FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Intervention (DI) and Rapid Intervention (RI) in people with Alcohol Addiction and Opiate Addiction, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meldon Kahan, MDCCFP FRCPC (416-323-6400 ext. 7511, meldon.kahan@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment retention (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01934751, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.