Trial Outcomes & Findings for Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders (NCT NCT02742246)
NCT ID: NCT02742246
Last Updated: 2023-11-18
Results Overview
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Baseline up to 8 weeks
Results posted on
2023-11-18
Participant Flow
Initiated is the number that attended at least 1 treatment session. Every attempt was made to get post treatment and follow up interviews on everyone randomized, regardless of how much of the active treatment the participant received.
Participant milestones
| Measure |
Standard Treatment as Usual (TAU)
This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
|
Individual Clinician-provided Cognitive Behavioral Therapy (CBT)
This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT
|
Computer Based Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
33
|
|
Overall Study
COMPLETED
|
21
|
16
|
22
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
11
|
Reasons for withdrawal
| Measure |
Standard Treatment as Usual (TAU)
This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
|
Individual Clinician-provided Cognitive Behavioral Therapy (CBT)
This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT
|
Computer Based Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy
|
|---|---|---|---|
|
Overall Study
Never initiated treatment
|
5
|
3
|
1
|
|
Overall Study
dropped out during treatment
|
7
|
13
|
10
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders
Baseline characteristics by cohort
| Measure |
Standard Treatment as Usual (TAU)
n=34 Participants
This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
|
Individual Clinician-provided CBT
n=32 Participants
This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT
|
CBT4CBT
n=33 Participants
In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 14 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Minority
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknkown
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · African-American
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Marked Hispanic only
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
32 participants
n=7 Participants
|
33 participants
n=5 Participants
|
99 participants
n=4 Participants
|
|
Completed High School
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
never married/living alone
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Unemployed
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Lifetime anxiety disorder
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Lifetime major depression
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
AUD Severity Rating
Mild
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
AUD Severity Rating
Moderate
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
AUD Severity Rating
Severe
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Audit Score 16 or higher
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
On probation/ court referred
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Mean days of alcohol use during the past 28 days
|
14.2 days
STANDARD_DEVIATION 7.8 • n=5 Participants
|
12.8 days
STANDARD_DEVIATION 8.6 • n=7 Participants
|
14.5 days
STANDARD_DEVIATION 9.2 • n=5 Participants
|
13.8 days
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Mean days of heavy drinking during the past 28 days
|
8.9 days
STANDARD_DEVIATION 8.1 • n=5 Participants
|
9.1 days
STANDARD_DEVIATION 8.4 • n=7 Participants
|
10.8 days
STANDARD_DEVIATION 9 • n=5 Participants
|
9.6 days
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Mean number of Drinks per drinking day during the past 28 days
|
6.3 drinks per drinking day
STANDARD_DEVIATION 4 • n=5 Participants
|
7.1 drinks per drinking day
STANDARD_DEVIATION 4 • n=7 Participants
|
8.7 drinks per drinking day
STANDARD_DEVIATION 8 • n=5 Participants
|
7.4 drinks per drinking day
STANDARD_DEVIATION 5.7 • n=4 Participants
|
|
Mean number of Years of regular alcohol use
|
20.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
22 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
18.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
20.3 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Audit Score
|
20.7 units on a scale
STANDARD_DEVIATION 9 • n=5 Participants
|
21.4 units on a scale
STANDARD_DEVIATION 8.6 • n=7 Participants
|
23.9 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
22 units on a scale
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
pre-treatment SCID Alcohol Symptom Count
|
7.1 symptoms
STANDARD_DEVIATION 2.7 • n=5 Participants
|
7.8 symptoms
STANDARD_DEVIATION 2.4 • n=7 Participants
|
8.6 symptoms
STANDARD_DEVIATION 2.9 • n=5 Participants
|
7.8 symptoms
STANDARD_DEVIATION 2.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 8 weeksPopulation: Intention to treat analysis
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.
Outcome measures
| Measure |
Standard Treatment as Usual (TAU)
n=34 Participants
This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
|
Individual Clinician-provided CBT
n=32 Participants
This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT
|
CBT4CBT
n=33 Participants
In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy
|
|---|---|---|---|
|
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
Baseline
|
49.26 percentage of days abstinent
Standard Deviation 27.84
|
53.73 percentage of days abstinent
Standard Deviation 29.80
|
47.57 percentage of days abstinent
Standard Deviation 31.82
|
|
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
Week 4
|
63.25 percentage of days abstinent
Standard Deviation 29.81
|
69.93 percentage of days abstinent
Standard Deviation 29.42
|
71.07 percentage of days abstinent
Standard Deviation 28.24
|
|
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
Week 8
|
69.26 percentage of days abstinent
Standard Deviation 26.18
|
68.10 percentage of days abstinent
Standard Deviation 29.85
|
75.12 percentage of days abstinent
Standard Deviation 25.08
|
PRIMARY outcome
Timeframe: from end of treatment at week 8 up to 6 monthsPopulation: Intention to treat process was used for data collection. All randomized participants were tracked and follow up data collection was attempted for the 6 months post treatment. Contact attempts were at 1 month, 3 month and 6 month post treatment. Analysis population numbers start at the number of randomized participants that completed the 1 month post treatment interview. Months 2 and 3 numbers reflex number of randomized participants that attended the 3 month post treatment interview and so on.
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly.
Outcome measures
| Measure |
Standard Treatment as Usual (TAU)
n=28 Participants
This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
|
Individual Clinician-provided CBT
n=29 Participants
This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT
|
CBT4CBT
n=27 Participants
In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy
|
|---|---|---|---|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
End of Treatment
|
69.26 percentage of days abstinent
Standard Deviation 26.18
|
68.10 percentage of days abstinent
Standard Deviation 29.85
|
73.28 percentage of days abstinent
Standard Deviation 25.03
|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Follow Up Month 1
|
66.71 percentage of days abstinent
Standard Deviation 32.06
|
75.86 percentage of days abstinent
Standard Deviation 29.29
|
74.74 percentage of days abstinent
Standard Deviation 32.64
|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Follow Up Month 2
|
63.86 percentage of days abstinent
Standard Deviation 35.61
|
71.96 percentage of days abstinent
Standard Deviation 30.91
|
77.06 percentage of days abstinent
Standard Deviation 28.59
|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Follow Up Month 3
|
55.14 percentage of days abstinent
Standard Deviation 37.53
|
68.12 percentage of days abstinent
Standard Deviation 33.15
|
82.55 percentage of days abstinent
Standard Deviation 22.84
|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Follow Up Month 4
|
67.70 percentage of days abstinent
Standard Deviation 36.48
|
63.74 percentage of days abstinent
Standard Deviation 35.90
|
82.14 percentage of days abstinent
Standard Deviation 23.07
|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Follow Up Month 5
|
68.17 percentage of days abstinent
Standard Deviation 37.16
|
68.27 percentage of days abstinent
Standard Deviation 37.13
|
85.12 percentage of days abstinent
Standard Deviation 23.66
|
|
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Follow Up Month 6
|
69.57 percentage of days abstinent
Standard Deviation 34.39
|
70.19 percentage of days abstinent
Standard Deviation 35.11
|
82.59 percentage of days abstinent
Standard Deviation 25.26
|
Adverse Events
Standard Treatment as Usual (TAU)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Individual Clinician-provided CBT
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT4CBT
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Treatment as Usual (TAU)
n=34 participants at risk
This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
|
Individual Clinician-provided CBT
n=32 participants at risk
This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT
|
CBT4CBT
n=33 participants at risk
In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization for Alcohol Use symptoms
|
5.9%
2/34 • Number of events 5 • Up to 8 months
|
0.00%
0/32 • Up to 8 months
|
6.1%
2/33 • Number of events 2 • Up to 8 months
|
|
Psychiatric disorders
Hospitalization for Detox
|
11.8%
4/34 • Number of events 4 • Up to 8 months
|
0.00%
0/32 • Up to 8 months
|
6.1%
2/33 • Number of events 3 • Up to 8 months
|
|
Psychiatric disorders
Hospitalization for Mental health
|
2.9%
1/34 • Number of events 1 • Up to 8 months
|
3.1%
1/32 • Number of events 2 • Up to 8 months
|
3.0%
1/33 • Number of events 1 • Up to 8 months
|
|
General disorders
Hospitalization for Lacerations to body
|
2.9%
1/34 • Number of events 1 • Up to 8 months
|
0.00%
0/32 • Up to 8 months
|
3.0%
1/33 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
Hospitalization for Intestinal issue
|
0.00%
0/34 • Up to 8 months
|
0.00%
0/32 • Up to 8 months
|
3.0%
1/33 • Number of events 1 • Up to 8 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian Kiluk, Associate Professor of Psychiatry
Yale University School of Medicine
Phone: 203-737-1544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place