Alcohol AbuseNCT00513708
Facilitating Aftercare for Alcohol Detox Patients
A study testing Motivation Enhancement Therapy (MET) and Peer-Twelve Step Facilitation (P-TSF) in people with Alcohol Abuse and Alcohol Dependence, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to determine whether peer visits (known as "12th Step Calls") and professional counselors (using "Motivational Enhancement Therapy") are effective helping alcoholics link to substance abuse treatment programs after being in the hospital for detox. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol Dependence
- What is being tested?
- Motivation Enhancement Therapy (MET) and Peer-Twelve Step Facilitation (P-TSF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helping Alcoholics Link to Substance Abuse Treatment Programs After Being in the Hospital for Detoxification
The purpose of this study is to determine whether peer visits (known as "12th Step Calls") and professional counselors (using "Motivational Enhancement Therapy") are effective helping alcoholics link to substance abuse treatment programs after being in the hospital for detox.
Read the 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.
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Being tested
- Motivation Enhancement Therapy (MET), Peer-Twelve Step Facilitation (P-TSF)
- Keywords
- Detoxification, Treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation Enhancement Therapy (MET)Behavioural
Also called Brief Intervention
Participants assigned to this arm will receive a 60-minute MET intervention in addition to "usual care" while hospitalized for detoxification.
Peer-Twelve Step Facilitation (P-TSF)Behavioural
Also called "12th Step Calls"
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | 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. |
| Motivational Enhancement Therapy (MET) | Experimental | 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. Receives: Behavioral: Motivation Enhancement Therapy (MET) |
| Peer-delivered Twelve Step Facilitation | Experimental | 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. Receives: Behavioral: Peer-Twelve Step Facilitation (P-TSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare")
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.
Measured: 1 month
Secondary outcomes (2)
Relapse to Drinking
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."
Measured: 30 days
Completed Inpatient Treatment
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Richard Blondell, State University of New York at Buffalo
- Investigators
- Richard D. Blondell, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513708
- Sponsor's protocol ID
- BLO-NIAAA-015616
- Other IDs
- K23AA015616
- Status last verified
- Oct 2020
- First submitted
- 7 Aug 2007
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blondell RD, Frydrych LM, Jaanimagi U, Ashrafioun L, Homish GG, Foschio EM, Bashaw HL. A randomized trial of two behavioral interventions to improve outcomes following inpatient detoxification for alcohol dependence. J Addict Dis. 2011 Apr;30(2):136-48. doi: 10.1080/10550887.2011.554777.
PubMed 21491295
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Alcoholics Link to Substance Abuse Treatment Programs After Being in the Hospital for Detoxification
- ClinicalTrials.gov ID
- NCT00513708
- Acronym / sponsor ID
- BLO-NIAAA-015616
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Keywords
- Detoxification, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Posted 8 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether peer visits (known as "12th Step Calls") and professional counselors (using "Motivational Enhancement Therapy") are effective helping alcoholics link to substance abuse treatment programs after being in the hospital for detox.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –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. |
| Motivational Enhancement Therapy (MET) | Experimental | Behavioral: Motivation 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. |
| Peer-delivered Twelve Step Facilitation | Experimental | Behavioral: Peer-Twelve Step Facilitation (P-TSF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Motivation Enhancement Therapy (MET)Also: Brief InterventionParticipants assigned to this arm will receive a 60-minute MET intervention in addition to "usual care" while hospitalized for detoxification. | Behavioural | Motivational Enhancement Therapy (MET) |
| Peer-Twelve Step Facilitation (P-TSF)Also: "12th Step Calls"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. | Behavioural | Peer-delivered Twelve Step Facilitation |
Primary outcome
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.
2 secondary outcomes
Relapse to Drinking
Time frame: 30 days
Completed Inpatient Treatment
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21491295Blondell RD, Frydrych LM, Jaanimagi U, Ashrafioun L, Homish GG, Foschio EM, Bashaw HL. A randomized trial of two behavioral interventions to improve outcomes following inpatient detoxification for alcohol dependence. J Addict Dis. 2011 Apr;30(2):136-48. doi: 10.1080/10550887.2011.554777.
Related trials for Alcohol Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
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.
Richard D. Blondell, MD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivation Enhancement Therapy (MET) and Peer-Twelve Step Facilitation (P-TSF) in people with Alcohol Abuse and Alcohol Dependence, run by State University of New York at Buffalo at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 14 Oct 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (time frame: 1 month). 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 NCT00513708, which also lists 1 linked publication.
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 14 Oct 2020.