Trial Outcomes & Findings for Facilitating Aftercare for Alcohol Detox Patients (NCT NCT00513708)
NCT ID: NCT00513708
Last Updated: 2020-10-14
Results Overview
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.
COMPLETED
NA
150 participants
1 month
2020-10-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
4
|
Baseline Characteristics
Facilitating Aftercare for Alcohol Detox Patients
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=50 Participants
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
n=50 Participants
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
n=50 Participants
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
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
146 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Continuous
|
46.58 years
STANDARD_DEVIATION 9.92 • n=99 Participants
|
44.96 years
STANDARD_DEVIATION 10.75 • n=107 Participants
|
44.48 years
STANDARD_DEVIATION 12.36 • n=206 Participants
|
45.34 years
STANDARD_DEVIATION 11.02 • n=7 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
50 participants
n=206 Participants
|
150 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 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.
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.
Outcome measures
| Measure |
Treatment as Usual
n=44 Participants
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
n=44 Participants
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
n=43 Participants
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.
|
|---|---|---|---|
|
Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare")
|
36 participants
|
36 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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."
Outcome measures
| Measure |
Treatment as Usual
n=42 Participants
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
n=43 Participants
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
n=41 Participants
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.
|
|---|---|---|---|
|
Relapse to Drinking
|
23 participants
|
25 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 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").
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.
Outcome measures
| Measure |
Treatment as Usual
n=19 Participants
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
n=25 Participants
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
n=12 Participants
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.
|
|---|---|---|---|
|
Completed Inpatient Treatment
|
15 Participants
|
21 Participants
|
9 Participants
|
Adverse Events
Treatment as Usual
Motivational Enhancement Therapy
Peer-delivered Twelve Step Facilitation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place