Alcohol Abuse, Alcohol Dependence
Conditions
Keywords
Detoxification, Treatment
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.
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.
Interventions
BEHAVIORALMotivation Enhancement Therapy (MET)
Participants assigned to this arm will receive a 60-minute MET intervention in addition to usual care while hospitalized for detoxification.
BEHAVIORALPeer-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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual 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. | 50 |
| Motivational Enhancement Therapy 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. | 50 |
| 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. | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Motivational Enhancement Therapy | Peer-delivered Twelve Step Facilitation | Treatment as Usual | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 49 Participants | 49 Participants | 146 Participants |
| Age, Continuous | 44.96 years STANDARD_DEVIATION 10.75 | 44.48 years STANDARD_DEVIATION 12.36 | 46.58 years STANDARD_DEVIATION 9.92 | 45.34 years STANDARD_DEVIATION 11.02 |
| Region of Enrollment United States | 50 participants | 50 participants | 50 participants | 150 participants |
| Sex: Female, Male Female | 25 Participants | 33 Participants | 20 Participants | 78 Participants |
| Sex: Female, Male Male | 25 Participants | 17 Participants | 30 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
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.
Time frame: 1 month
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare) | 36 participants |
| Motivational Enhancement Therapy | Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare) | 36 participants |
| Peer-delivered Twelve Step Facilitation | Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare) | 32 participants |
Secondary
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.
Time frame: 90 days
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Completed Inpatient Treatment | 15 Participants |
| Motivational Enhancement Therapy | Completed Inpatient Treatment | 21 Participants |
| Peer-delivered Twelve Step Facilitation | Completed Inpatient Treatment | 9 Participants |
Secondary
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.
Time frame: 30 days
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Relapse to Drinking | 23 participants |
| Motivational Enhancement Therapy | Relapse to Drinking | 25 participants |
| Peer-delivered Twelve Step Facilitation | Relapse to Drinking | 20 participants |