Facilitating Aftercare for Alcohol Detox Patients

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00513708
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 13
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse; Alcohol Dependence	Behavioral: Motivation Enhancement Therapy (MET); Behavioral: Peer-Twelve Step Facilitation (P-TSF)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Helping Alcoholics Link to Substance Abuse Treatment Programs After Being in the Hospital for Detoxification
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

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.
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.	Behavioral: Motivation Enhancement Therapy (MET); Participants assigned to this arm will receive a 60-minute MET intervention in addition to "usual care" while hospitalized for detoxification.; Other Names: Brief Intervention
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.	Behavioral: Peer-Twelve Step Facilitation (P-TSF); 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: "12th Step Calls"

Outcome Measures

Primary Outcome Measures

1. Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") [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.

Secondary Outcome Measures

1. Relapse to Drinking [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."

2. Completed Inpatient Treatment [90 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erie County Medical Center	Buffalo	New York	United States	14215

Sponsors and Collaborators

• State University of New York at Buffalo
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Richard D. Blondell, MD, State University of New York at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Blondell, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT00513708
• Other Study ID Numbers: BLO-NIAAA-015616; K23AA015616
• First Posted: Aug 9, 2007
• Last Update Posted: Oct 14, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Richard Blondell, Principal Investigator, State University of New York at Buffalo: Detoxification; Treatment
• Additional relevant MeSH terms: Alcoholism

Study Results

Participant Flow

Arm/Group Title	Treatment as Usual	Motivational Enhancement Therapy	Peer-delivered Twelve Step Facilitation
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	50	50	50
COMPLETED	46	46	46
NOT COMPLETED	4	4	4

Baseline Characteristics

Arm/Group Title	Treatment as Usual	Motivational Enhancement Therapy	Peer-delivered Twelve Step Facilitation	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	50	50	50	150
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	49 98%	48 96%	49 98%	146 97.3%
>=65 years	1 2%	2 4%	1 2%	4 2.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.58 (9.92)	44.96 (10.75)	44.48 (12.36)	45.34 (11.02)
Sex: Female, Male (Count of Participants)
Female	20 40%	25 50%	33 66%	78 52%
Male	30 60%	25 50%	17 34%	72 48%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	50 100%	150 100%

Outcome Measures

1. Primary Outcome

Title	Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare")
Description	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.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

There were 50 participants in each arm. Per protocol, the "number of participants analyzed" represents the number that had outcome data (i.e, "linked to aftercare" or "not linked to aftercare") available at the 30-day follow-up.

Arm/Group Title	Treatment as Usual	Motivational Enhancement Therapy	Peer-delivered Twelve Step Facilitation
Arm/Group Description	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.	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.	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.
Measure Participants	44	44	43
Number [participants]	36 72%	36 72%	32 64%

2. Secondary Outcome

Title	Relapse to Drinking
Description	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."
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

There were 50 participants in each arm. Per protocol, the "number of participants analyzed" represents the number that had outcome data (i.e, "relapse" or "no relapse") available at the 30-day follow-up.

Arm/Group Title	Treatment as Usual	Motivational Enhancement Therapy	Peer-delivered Twelve Step Facilitation
Arm/Group Description	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.	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.	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.
Measure Participants	42	43	41
Number [participants]	23 46%	25 50%	20 40%

3. Secondary Outcome

Title	Completed Inpatient Treatment
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

There were 50 participants in each arm; the "number of participants analyzed" represents the number of those 50 in each arm who were admitted to an inpatient treatment program (e.g., a "28-day program").

Arm/Group Title	Treatment as Usual	Motivational Enhancement Therapy	Peer-delivered Twelve Step Facilitation
Arm/Group Description	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.	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.	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.
Measure Participants	19	25	12
Number [Participants]	15 30%	21 42%	9 18%

Adverse Events

Time Frame	During the initial 30-day follow-up one participant expressed suicidal ideation, which was reported to the IRB. Participant recruitment was suspended for approximately 2 weeks until a new protocol was developed.
Adverse Event Reporting Description	The participant, who expressed suicidal ideation, was referred to a counseling program, which resolved the problem. The participant was stable at the 90-day follow-up. It was determined that the participant used suicidal ideation in an attempt to ask the research for a date to have coffee.
Arm/Group Title	Treatment as Usual		Motivational Enhancement Therapy		Peer-delivered Twelve Step Facilitation
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Treatment as Usual		Motivational Enhancement Therapy		Peer-delivered Twelve Step Facilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment as Usual		Motivational Enhancement Therapy		Peer-delivered Twelve Step Facilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Treatment as Usual		Motivational Enhancement Therapy		Peer-delivered Twelve Step Facilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.