- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00513708
Facilitating Aftercare for Alcohol Detox Patients
Helping Alcoholics Link to Substance Abuse Treatment Programs After Being in the Hospital for Detoxification
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For those with an alcohol use disorder, the decision to seek detoxification treatment often represents a desire or willingness to change drinking behavior. This gives clinicians with the opportunity to intervene and improve the lives of these individuals. Even patients admitted involuntarily or who have been coerced may be amenable to change. Therefore, inpatient alcohol detoxification treatment offers an opportunity to prepare these patients for and link them with aftercare treatment.
Unfortunately, clinicians have little to guide them on how the current standard of care for alcohol detoxification might be improved. Improvement in clinical practice is ideally driven by clinical research, but there is little recent published information to guide the development of evidence-based pharmacological or psychological practices or interventions in detoxification settings. As a result, alcohol detoxification treatment has changed little over the past 25 years.
Taken as a whole, the literature suggests that the outcomes of inpatient detoxification are less than optimal. A limited number of published studies suggest that a majority of these patients are not linked to any aftercare following inpatient detoxification treatment and return to drinking within a few weeks of hospital discharge. However, there is some evidence to suggest that interventions, performed while the patient is hospitalized, could encourage patients to initiate involvement in aftercare (i.e., professional treatment and/or mutual self-help following hospitalization) and to decrease drinking or initiate abstinence. Motivational Enhancement Therapy and Twelve-Step Facilitation are two interventions that show promise.
The study proposed in this study addresses this issue by testing two brief interventions, Motivation Enhancement Therapy (MET) and Peer-Twelve Step Facilitation (P-TSF, also known as "12th Step Calls"), which have shown potential to enhance initiation of a period of abstinence and engagement in treatment and/or self-help programs among alcohol detoxification patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14215
- Erie County Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female inpatients 18 years of age or older.
- Participants will have a current DSM-IV diagnosis of alcohol abuse or dependence.
- Able to understand/speak English
- Participants will have signed a witnessed informed consent.
Exclusion Criteria:
- Cognitive impairment (e.g., mental retardation)
- Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, or dementia
- Participants who are homeless, without contact person
- Participants enrolled in a methadone maintenance treatment program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment As Usual (TAU)
Treatment as Usual (TAU): Participants randomized to this arm will receive "usual care" (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification.
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Experimental: Motivational Enhancement Therapy (MET)
Participants randomized to this arm will receive "usual care" (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional.
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Participants assigned to this arm will receive a 60-minute MET intervention in addition to "usual care" while hospitalized for detoxification.
Other Names:
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Experimental: Peer-delivered Twelve Step Facilitation
Participants randomized to this arm will receive "usual care" (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program.
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In addition to "usual care" while hospitalized for detoxification, participants assigned to this arm will receive a 60-minute visit by peers who are "recovering from alcoholism" and who are active in 12-step oriented self-help programs.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare")
Time Frame: 1 month
|
Linkage to alcohol behavioral therapy counseling (i.e., "aftercare") was defined as: arriving for the first outpatient chemical dependency counseling visit, being admitted to an inpatient or residential chemical dependency treatment facility, or attending at least one meeting of a help-help program such as Alcoholics Anonymous.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse to Drinking
Time Frame: 30 days
|
Relapse to drinking was defined as the consumption of one or more standard drinks (approximately 12 grams of ethanol)during the first 30 days following discharge from the inpatient detoxification unit.
The date of discharge was considered to be "Day 1."
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30 days
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Completed Inpatient Treatment
Time Frame: 90 days
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Completion of inpatient treatment was defined as being admitted to and successfully discharged from an inpatient alcohol treatment program (e.g., a "28-day program").
Participants who left the inpatient program "against medical advice" or who received an "administrative discharge" were not considered to have successfully completed the inpatient program.
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90 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Richard D. Blondell, MD, State University of New York at Buffalo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BLO-NIAAA-015616
- K23AA015616 (U.S. NIH Grant/Contract)
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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