Trial Outcomes & Findings for Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence (NCT NCT01055171)
NCT ID: NCT01055171
Last Updated: 2016-03-08
Results Overview
Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.
COMPLETED
PHASE2
44 participants
Multiple times throughout cue exposure during retrieval session (Session 1)
2016-03-08
Participant Flow
Participants were considered enrolled if they completed both the retrieval and testing procedure (44).
Participant milestones
| Measure |
Propranolol
Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
|
Placebo
Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
Retrieval Completion
|
25
|
24
|
|
Overall Study
Test Procedure Completion
|
21
|
23
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Propranolol
n=21 Participants
Patients will receive Propranolol in this condition.
Propranolol: 40 mg; Single Administration.
|
Placebo
n=23 Participants
Patient to receive placebo in this condition.
Placebo: 40 mg; Single Dose.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Greater than or equal to 35 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
Less than 35 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Multiple times throughout cue exposure during retrieval session (Session 1)Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.
Outcome measures
| Measure |
Propranolol
n=21 Participants
Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
|
Placebo
n=23 Participants
Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
|
|---|---|---|
|
Retrieval Session Distress Scores (Session 1)
|
54.5 units on a scale
Standard Error 26.8
|
73.9 units on a scale
Standard Error 20.9
|
PRIMARY outcome
Timeframe: Multiple times throughout cue exposure during retrieval session (Session 1)Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.
Outcome measures
| Measure |
Propranolol
n=21 Participants
Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
|
Placebo
n=23 Participants
Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
|
|---|---|---|
|
Retrieval Session Craving Scores (Session 1)
|
49.1 units on a scale
Standard Error 31.3
|
71.6 units on a scale
Standard Error 20.4
|
PRIMARY outcome
Timeframe: Multiple times throughout cue exposure during test session (Session 2)Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.
Outcome measures
| Measure |
Propranolol
n=21 Participants
Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
|
Placebo
n=23 Participants
Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
|
|---|---|---|
|
Test Session Distress Scores (Session 2)
|
35.1 units on a scale
Standard Error 3.7
|
48.0 units on a scale
Standard Error 3.5
|
PRIMARY outcome
Timeframe: Multiple times throughout cue exposure during test session (Session 2)Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.
Outcome measures
| Measure |
Propranolol
n=21 Participants
Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
|
Placebo
n=23 Participants
Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
|
|---|---|---|
|
Test Session Craving Scores (Session 2)
|
51.0 units on a scale
Standard Error 3.7
|
53.9 units on a scale
Standard Error 3.5
|
SECONDARY outcome
Timeframe: 90 days prior to participation in study up to 2-week follow up session (Session 3)Proportion of drinking days from 90 days prior to the screening to the follow-up period.
Outcome measures
| Measure |
Propranolol
n=21 Participants
Patients will receive Propranolol in this condition.
Propranolol : 40 mg; Single Administration.
The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
|
Placebo
n=23 Participants
Patient to receive placebo in this condition.
Placebo : 40 mg; Single Dose.
The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)
|
|---|---|---|
|
Proportion of Drinking Days
|
42.2 Drinking days
Standard Error 6.4
|
45.9 Drinking days
Standard Error 6.8
|
Adverse Events
Propranolol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Saladin
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place