Trial Outcomes & Findings for Family Based Contingency Management for Adolescent Alcohol Abuse (NCT NCT00595478)
NCT ID: NCT00595478
Last Updated: 2018-03-29
Results Overview
Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Weekly up to 14 weeks
Results posted on
2018-03-29
Participant Flow
Participant milestones
| Measure |
(MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment
|
(MET)/CBT
Motivational Enhancement Therapy (MET)/CBT
Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment
|
|---|---|---|
|
Treatment
STARTED
|
37
|
38
|
|
Treatment
COMPLETED
|
37
|
38
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
|
36-week Follow-up Period
STARTED
|
37
|
38
|
|
36-week Follow-up Period
COMPLETED
|
28
|
30
|
|
36-week Follow-up Period
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
(MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment
|
(MET)/CBT
Motivational Enhancement Therapy (MET)/CBT
Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment
|
|---|---|---|
|
36-week Follow-up Period
Lost to Follow-up
|
5
|
4
|
|
36-week Follow-up Period
Withdrawal by Subject
|
4
|
4
|
Baseline Characteristics
Family Based Contingency Management for Adolescent Alcohol Abuse
Baseline characteristics by cohort
| Measure |
(MET)/CBT+CM/BPT
n=37 Participants
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment
|
(MET)/CBT
n=38 Participants
Motivational Enhancement Therapy (MET)/CBT
Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.1 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
16.2 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
16.1 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Tobacco user
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Mean intake proportion of days used alcohol in past 30 days
|
0.12 proportion of days used alcohol
STANDARD_DEVIATION 0.16 • n=5 Participants
|
0.12 proportion of days used alcohol
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.12 proportion of days used alcohol
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Mean drinks per drinking day
|
5.7 Drinks
STANDARD_DEVIATION 4.9 • n=5 Participants
|
6.4 Drinks
STANDARD_DEVIATION 4.5 • n=7 Participants
|
6.0 Drinks
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
DSM Alcohol Use Disorder
Dependence
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
DSM Alcohol Use Disorder
Abuse only
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
DSM Alcohol Use Disorder
None
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly up to 14 weeksNumber of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)
Outcome measures
| Measure |
(MET)/CBT+CM/BPT
n=37 Participants
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment
|
(MET)/CBT
n=38 Participants
Motivational Enhancement Therapy (MET)/CBT
Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment
|
|---|---|---|
|
Alcohol Abstinence
|
2.9 Samples
Standard Deviation 3.5
|
2.6 Samples
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Monthly up to 9 months (36 weeks)Population: The analysis population consisted of only participants with follow-up (alcohol use) data on at least 85% of the days in the 36-week follow-up period.
Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.
Outcome measures
| Measure |
(MET)/CBT+CM/BPT
n=28 Participants
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment
|
(MET)/CBT
n=30 Participants
Motivational Enhancement Therapy (MET)/CBT
Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment
|
|---|---|---|
|
Days of Alcohol Use During 36-week Follow-up Period
|
5.6 percentage of days used
Standard Deviation 8.8
|
7.6 percentage of days used
Standard Deviation 10.6
|
Adverse Events
(MET)/CBT+CM/BPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
(MET)/CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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